18 results on '"Worp, H. Bart"'
Search Results
2. Current practice and attitudes of stroke physicians towards rhythm-control therapy for stroke prevention: results of an international survey
- Author
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Jensen, Märit, Al-Shahi Salman, Rustam, Ng, G. Andre, van der Worp, H. Bart, Loh, Peter, Campbell, Bruce C. V., Kalman, Jonathan M., Hill, Michael D., Sposato, Luciano A., Andrade, Jason G., Metzner, Andreas, Kirchhof, Paulus, and Thomalla, Götz
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- 2023
- Full Text
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3. Impact of the lockdown on acute stroke treatments during the first surge of the COVID-19 outbreak in the Netherlands
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Benali, Faysal, Stolze, Lotte J., Rozeman, Anouk D., Dinkelaar, Wouter, Coutinho, Jonathan M., Emmer, Bart J., Gons, Rob A. R., Yo, Lonneke F. S., van Tuijl, Julia H., Boukrab, Issam, van Dam-Nolen, Dianne H. K., van den Wijngaard, Ido R., Lycklama à Nijeholt, Geert J., de Laat, Karlijn F., van Dijk, Lukas C., den Hertog, Heleen M., Flach, H. Zwenneke, Wermer, Marieke J. H., van Walderveen, Marianne A. A., Brouwers, Paul J. A. M., Bulut, Tomas, Vermeer, Sarah E., Bernsen, Marie Louise E., Uyttenboogaart, Maarten, Bokkers, Reinoud P. H., Boogaarts, Jeroen D., de Leeuw, Frank-Erik, van der Worp, H. Bart, van der Schaaf, Irene C., Schonewille, Wouter J., Vos, Jan A., Remmers, Michel J. M., Imani, Farshad, Dippel, Diederik W. J., van Zwam, Wim H., Nederkoorn, Paul J., and van Oostenbrugge, Robert J.
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- 2022
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4. INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4): study protocol for a randomized controlled trial
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Song, Lili, Chen, Chen, Chen, Xiaoying, Guo, Yijia, Liu, Feifeng, Lin, Yapeng, Billot, Laurent, Li, Qiang, Liu, Hueiming, Si, Lei, Ouyang, Menglu, Arima, Hisatomi, Bath, Philip M., Ford, Gary A., Robinson, Thompson, Sandset, Else Charlotte, Saver, Jeffrey L., Sprigg, Nikola, van der Worp, H. Bart, Zhang, Chunfang, Yang, Jie, Li, Gang, and Anderson, Craig S.
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- 2021
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5. Multicentre Randomised trial of Acute Stroke treatment in the Ambulance with a nitroglycerin Patch (MR ASAP): study protocol for a randomised controlled trial
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van den Berg, Sophie A., Dippel, Diederik W. J., Hofmeijer, Jeannette, Fransen, Puck S. S., Caminada, Klaartje, Siegers, Arjen, Kruyt, Nyika D., Kerkhoff, Henk, de Leeuw, Frank-Erik, Nederkoorn, Paul J., van der Worp, H. Bart, and on behalf of the MR ASAP Investigators
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- 2019
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6. Statistical analysis plan for the EuroHYP-1 trial: European multicentre, randomised, phase III clinical trial of the therapeutic hypothermia plus best medical treatment versus best medical treatment alone for acute ischaemic stroke
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Winkel, Per, Bath, Philip M., Gluud, Christian, Lindschou, Jane, van der Worp, H. Bart, Macleod, Malcolm R., Szabo, Istvan, Durand-Zaleski, Isabelle, Schwab, Stefan, and for the EuroHYP-1 trial investigators
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Male ,Time Factors ,Cost effectiveness ,Modified Ranking scale ,Medicine (miscellaneous) ,Logistic regression ,Randomised clinical trial ,Brain Ischemia ,Disability Evaluation ,0302 clinical medicine ,Clinical Protocols ,Medizinische Fakultät ,Hypothermia, Induced ,Risk Factors ,Odds Ratio ,Medicine ,Pharmacology (medical) ,030212 general & internal medicine ,education.field_of_study ,lcsh:R5-920 ,Acute ischaemic stroke – Randomised clinical trial – Modified Ranking scale – Quality of life – Cooling – Cost-effectiveness ,Middle Aged ,Combined Modality Therapy ,3. Good health ,Intention to Treat Analysis ,Europe ,Stroke ,Treatment Outcome ,Research Design ,Acute ischaemic stroke ,Data Interpretation, Statistical ,Female ,lcsh:Medicine (General) ,Cooling ,Quality of life ,medicine.medical_specialty ,Population ,Minimisation (clinical trials) ,Ordinal regression ,Update ,03 medical and health sciences ,Humans ,ddc:610 ,Adverse effect ,education ,Aged ,business.industry ,Recovery of Function ,Clinical trial ,Logistic Models ,Sample size determination ,Physical therapy ,Linear Models ,Cost-effectiveness ,business ,030217 neurology & neurosurgery - Abstract
Background: Cooling may reduce infarct size and improve neurological outcomes in patients with ischaemic stroke. In phase II trials, cooling awake patients with ischaemic stroke has been shown to be feasible and safe, but the effects in functional outcomes has not yet been investigated in an adequately sized randomised clinical trial.Methods/design: The EuroHYP-1 trial is a multinational, randomised, superiority phase III clinical trial with masked outcome assessment testing the benefits and harms of therapeutic cooling in awake adult patients with acute ischaemic stroke. The outcomes dealt with here include the primary outcome the Rankin score (mRS) at day 91 +/-14 days after randomisation. The secondary and exploratory outcomes at day 91 +/-14 days unless otherwise stated encompassing: (1) death or dependency, defined as mRS score > 2; (2) death; (3) National Institutes of Health Stroke Score; (4) brain infarct size at 48 +/-24 hours; (5) EQ-5D-5 L score, and (6) WHODAS 2.0 score. Other outcomes are: the primary safety outcome serious adverse events; and the incremental cost-effectiveness, and cost utility ratios. The analysis sets include (1) the intention-to-treat population, and (2) the per protocol population. The sample size is estimated to 800 patients (5% type 1 and 20% type 2 errors). All analyses are adjusted for the protocol-specified stratification variables (nationality of centre), and the minimisation variables. In the analysis, we use ordinal regression (the primary outcome), logistic regression (binary outcomes), general linear model (continuous outcomes), and the Poisson or negative binomial model (rate outcomes).Discussion: Major adjustments compared with the original statistical analysis plan encompass: (1) adjustment of analyses by nationality; (2) power calculations for the secondary outcomes; (3) to address the multiplicity problem using of a fixed-sequence testing procedure starting with the primary outcome followed by the secondary outcomes ordered according to falling power; (4) assignment of worst possible score to patients who are not alive at the planned date of measurement of the continuous scores; (5) improved imputations; (6) outline of a supplementary exploratory analysis of the temperature measurements and time to death; and (7) substantial reduction of sample size.Trial registration: Clinicaltrials.gov, identifier: NCT01833312. 4 April 2013.
- Published
- 2017
7. Advance directives, proxy opinions, and treatment restrictions in patients with severe stroke.
- Author
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de Kort, Floor A. S., Geurtsr, Marjolein, de Kort, Paul L. M., van Tuijl, Julia H., van Thiel, Ghislaine J. M. W., Kappelle, L. Jaap, and van der Worp, H. Bart
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INTERVIEWING ,LONGITUDINAL method ,RESEARCH methodology ,PROXY ,QUESTIONNAIRES ,TERMINAL care ,ADVANCE directives (Medical care) ,LIVING wills ,STROKE patients ,BARTHEL Index ,PATIENT autonomy ,PATIENT decision making - Abstract
Background: Patients with severe stroke often do not have the capacity to participate in discussions on treatment restrictions because of a reduced level of consciousness, aphasia, or another cognitive disorder. We assessed the role of advance directives and proxy opinions in the decision-making process of incapacitated patients. Methods: Sixty patients with severe functional dependence (Barthel Index ≤6) at day four after ischemic stroke or intracerebral hemorrhage were included in a prospective two-center cohort study. The decision-making process with respect to treatment restrictions was assessed by means of a semi-structured questionnaire administered to the treating physician at the day of inclusion. Results: Forty-nine patients (82%) did not have the capacity to participate in the decision-making process. In eight patients, there was no discussion on treatment restrictions and full care was installed. In 41 patients, the decision whether to install treatment restrictions was discussed with proxies. One patient had a written advance directive. In the remaining 40 patients, proxies based their opinion on previously expressed wishes of the patient (18 patients) or advised in the best interest of the patient (22 patients). In 36 of 41 patients, treatment restrictions were installed after agreement between physician and proxy. At six months, 23 of 49 patients had survived. In only three of them the decision on treatment restrictions was based on previously expressed wishes. Remarkably, two of these survivors could not recall any of their alleged previously expressed wishes. Conclusions: Treatment restrictions were installed in the majority of incapacitated patients after stroke. Proxy opinions frequently served as the best way to respect the patients' autonomy, but their accuracy remains unclear. [ABSTRACT FROM AUTHOR]
- Published
- 2017
- Full Text
- View/download PDF
8. Pioglitazone and the secondary prevention of cardiovascular disease. A meta-analysis of randomized-controlled trials.
- Author
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de Jong, Marit, van der Worp, H. Bart, van der Graaf, Yolanda, Visseren, Frank L. J., and Westerink, Jan
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PIOGLITAZONE , *CARDIOVASCULAR disease treatment , *RANDOMIZED controlled trials , *MYOCARDIAL infarction , *HEART failure , *THERAPEUTICS - Abstract
Background and aims: Pioglitazone targets multiple pathogenic pathways involved in the development of cardiovascular diseases (CVD). The aim of this systematic review and meta-analysis is to assess the effects of pioglitazone treatment on the secondary prevention of CVD. Methods: Randomized-controlled trials of pioglitazone in patients with CVD were identified through PubMed, Embase, Cochrane and CINAHL, in a search up to May 2016. Studies were included if pioglitazone was compared with any control (usual care, placebo or active comparator) and if patients were previously diagnosed with CVD. The outcomes of interest included major adverse cardiovascular events (MACE), myocardial infarction (MI), stroke, all-cause mortality and heart failure (HF). All outcomes were compared by pooled risk ratios (RR) with a 95% confidence interval (CI). Pooled estimates were calculated using a random-effects model. Results: Ten studies reported the effects of pioglitazone on any of the outcomes of interest. Pioglitazone reduced recurrent MACE (RR 0.74, 95% 0.60-0.92; I2 = 35), MI (RR 0.77, 95% CI 0.64-0.93; I2 = 0%), or stroke (RR 0.81, 95% CI 0.68-0.96; I2 = 0%). Pioglitazone did not reduce all-cause mortality (RR 0.94, 95% CI 0.81-1.08; I2 = 0%), whereas pioglitazone treatment was associated with an increased risk of HF (RR 1.33, 95% CI 1.14-1.54). Conclusions: Pioglitazone lowers the risk of recurrent MACE, stroke, or MI in patients with clinical manifest vascular disease. Pioglitazone does not lower the risk for all-cause mortality, and increases the risk for the development of HF. [ABSTRACT FROM AUTHOR]
- Published
- 2017
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9. Temporal profile of body temperature in acute ischemic stroke: relation to infarct size and outcome.
- Author
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Geurts, Marjolein, Scheijmans, Féline E. V., van Seeters, Tom, Biessels, Geert J., Kappelle, L. Jaap, Velthuis, Birgitta K., and van der Worp, H. Bart
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BODY temperature ,COMPUTED tomography ,MAGNETIC resonance imaging ,REGRESSION analysis ,MYOCARDIAL infarction - Abstract
Background: High body temperatures after ischemic stroke have been associated with larger infarct size, but the temporal profile of this relation is unknown. We assess the relation between temporal profile of body temperature and infarct size and functional outcome in patients with acute ischemic stroke. Methods: In 419 patients with acute ischemic stroke we assessed the relation between body temperature on admission and during the first 3 days with both infarct size and functional outcome. Infarct size was measured in milliliters on CT or MRI after 3 days. Poor functional outcome was defined as a modified Rankin Scale score ≥3 at 3 months. Results: Body temperature on admission was not associated with infarct size or poor outcome in adjusted analyses. By contrast, each additional 1.0 °C in body temperature on day 1 was associated with 0.31 ml larger infarct size (95% confidence interval (CI) 0.04-0.59), on day 2 with 1.13 ml larger infarct size(95% CI, 0.83-1.43), and on day 3 with 0.80 ml larger infarct size (95% CI, 0.48-1.12), in adjusted linear regression analyses. Higher peak body temperatures on days two and three were also associated with poor outcome (adjusted relative risks per additional 1.0 °C in body temperature, 1.52 (95% CI, 1.17-1.99) and 1.47 (95% CI, 1.22-1.77), respectively). Conclusions: Higher peak body temperatures during the first days after ischemic stroke, rather than on admission, are associated with larger infarct size and poor functional outcome. This suggests that prevention of high temperatures may improve outcome if continued for at least 3 days. [ABSTRACT FROM AUTHOR]
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- 2016
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10. Apixaban versus Antiplatelet drugs or no antithrombotic drugs after anticoagulationassociated intraCerebral HaEmorrhage in patients with Atrial Fibrillation (APACHE-AF): study protocol for a randomised controlled trial.
- Author
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van Nieuwenhuizen, Koen M., van der Worp, H. Bart, Algra, Ale, Kappelle, L. Jaap, Rinkel, Gabriel J. E., van Gelder, Isabelle C., Schutgens, Roger E. G., and Klijn, Catharina J. M.
- Subjects
- *
PLATELET aggregation inhibitors , *APIXABAN , *ANTICOAGULANTS , *ATRIAL fibrillation , *RANDOMIZED controlled trials , *STROKE prevention - Abstract
Background: There is a marked lack of evidence on the optimal prevention of ischaemic stroke and other thromboembolic events in patients with non-valvular atrial fibrillation and a recent intracerebral haemorrhage during treatment with oral anticoagulation. These patients are currently treated with oral anticoagulants, antiplatelet drugs, or no antithrombotic treatment, depending on personal and institutional preferences. Compared with warfarin, the direct oral anticoagulant apixaban reduces the risk of stroke or systemic embolism, intracranial haemorrhage, and case fatality in patients with atrial fibrillation. Compared with aspirin, apixaban reduces the risk of stroke or systemic embolism in patients with atrial fibrillation, and has a similar risk of intracerebral haemorrhage. Novel oral anticoagulants have not been evaluated in patients with atrial fibrillation and a recent intracerebral haemorrhage. To inform a phase III trial, the phase II Apixaban versus Antiplatelet drugs or no antithrombotic drugs after anticoagulation-associated intraCerebral HaEmorrhage in patients with Atrial Fibrillation (APACHE-AF) trial aims to obtain estimates of the rates of vascular death or non-fatal stroke in patients with atrial fibrillation and a recent anticoagulation-associated intracerebral haemorrhage treated with apixaban and in those in whom oral anticoagulation is avoided. Methods/Design: APACHE-AF is a phase II, multicentre, open-label, parallel-group, randomised clinical trial with masked outcome assessment. One hundred adults with a history of atrial fibrillation and a recent intracerebral haemorrhage during treatment with anticoagulation in whom clinical equipoise exists on the optimal stroke prevention strategy will be enrolled in 14 hospitals in The Netherlands. These patients will be randomly assigned in a 1:1 ratio to either apixaban or to avoiding oral anticoagulation. Patients in the control group may be treated with antiplatelet drugs at the discretion of the treating physician. The primary outcome is the composite of vascular death or non-fatal stroke during follow-up. We aim to include 100 patients in 2.5 years. All patients will be followed-up for the duration of the study, but at least for 1 year. Recruitment commenced in September 2014 and is ongoing. This trial is funded by the Dutch Heart Foundation (2012 T077) and ZonMW (015008048). [ABSTRACT FROM AUTHOR]
- Published
- 2015
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11. Quality of life after surgical decompression for a space-occupying middle cerebral artery infarct: A cohort study.
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van Middelaar, Tessa, Richard, Edo, van der Worp, H. Bart, van den Munckhof, Pepijn, Nieuwkerk, Pythia T., Visser, Marieke C., Stam, Jan, and Nederkoorn, Paul J.
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QUALITY of life ,SURGICAL decompression ,DECOMPRESSIVE craniectomy ,CEREBRAL arteries ,INFARCTION - Abstract
Background: In patients with a space-occupying middle cerebral artery (MCA) infarct surgical decompression reduces the risk of death, but increases the chance of survival with severe disability. We assessed quality of life (QoL), symptoms of depression, and caregiver burden at long-term follow-up. Methods: Patients treated in two academic centres between 2007 and 2012 were included. Follow-up was at least six months. Patients and caregivers were interviewed separately. QoL was assessed with a visual analogue scale and the 36-item Short-Form health survey (SF-36); depression with the Hospital Anxiety and Depression Scale; and caregiver burden with the Caregiver Strain Index. Results: Twenty five patients were enrolled, of whom seven had an infarct in the dominant hemisphere. After a median follow-up of 26 months (IQR 11-46) the median SF-36 mental component score was 54.4 (IQR 45-60), indicating a mental QoL comparable to that in the general population. The median SF-36 physical component score was 32.7 (IQR 22-38), indicating a worse physical QoL. Dominance of the hemisphere did not influence QoL. 79 % of patients and 65 % of caregivers would, in retrospect, again choose for surgery. 26 % of patients had signs of depression and 64 % of caregivers were substantially burdened in their daily life. Conclusions: Mental QoL after surgical decompression for space-occupying MCA infarct is comparable to that in the general population, whereas physical QoL is worse. Dominance of the hemisphere did not influence QoL. The majority of caregivers experience substantial burden. Most patients and caregivers stand by their decision for hemicraniectomy. [ABSTRACT FROM AUTHOR]
- Published
- 2015
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12. Ipsilateral foetal-type posterior cerebral artery is associated with cognitive decline after carotid revascularisation.
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Altinbas, Aysun, Hendrikse, Jeroen, Algra, Ale, van Zandvoort, Martine J. E., Brown, Martin M., Bonati, Leo H., de Borst, Gert Jan, Kappelle, L. Jaap, and van der Worp, H. Bart
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ANGIOPLASTY ,CAROTID endarterectomy ,CAROTID artery stenosis ,SYMPTOMATIC Parkinson's disease ,ANGIOGRAPHY ,POSTERIOR cerebral artery - Abstract
Background Stenosis of the internal carotid artery has been associated with cognitive impairment and decline. However, studies testing the effect of carotid revascularisation on cognition have had conflicting results. This may in part be explained by variation in the flow territory of the carotid artery. In 12 to 36% of the patients, the posterior cerebral artery is mainly or exclusively supplied by the internal carotid artery via a foetal-type posterior cerebral artery. In these patients, ipsilateral carotid artery stenosis is likely to result in a larger area with hypoperfusion than in case of a normal posterior cerebral artery. Patients with a foetal-type posterior cerebral artery could therefore benefit more from revascularisation. We compared the effects of carotid revascularisation on cognition between patients with a foetal-type and those with a normal posterior cerebral artery. Methods Patients with symptomatic internal carotid artery stenosis ⩾ 50%, enrolled in the International Carotid Stenting Study (ICSS) at a single centre, underwent detailed neuropsychological examinations before and 6 months after revascularisation. Cognitive test results were standardized into z-scores, from which a cognitive sumscore was calculated. The primary outcome was the change in cognitive sumscore between baseline and follow-up. Changes in cognitive sumscore were compared between patients with an ipsilateral foetal-type and those with a normal posterior cerebral artery, as assessed with CT or MR angiography. Results Of 145 patients enrolled in ICSS at the centre during the study period, 98 had both angiography at baseline and neuropsychological examination at baseline and at 6-months follow-up. The cognitive sum score decreased by 0.28 (95% confidence interval, 0.10 to 0.45) in 13 patients with an ipsilateral foetal-type posterior cerebral artery and by 0.07 (95% CI, 0.002 to 0.15) in 85 patients with a normal posterior cerebral artery (mean difference, - 0.20; 95% CI, -0.40 to -0.01). This did not change essentially after adjustment for baseline factors. Conclusion An ipsilateral foetal-type posterior cerebral artery appears to increase cognitive decline after carotid revascularisation. Our findings have to be reproduced in an independent study before further implications can be made. [ABSTRACT FROM AUTHOR]
- Published
- 2014
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13. Hemicraniectomy after middle cerebral artery infarction with life-threatening Edema trial (HAMLET). Protocol for a randomised controlled trial of decompressive surgery in space-occupying hemispheric infarction.
- Author
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Hofmeijer, Jeannette, Amelink, G. Johan, Algra, Ale, Van Gijn, Jan, Macleod, Malcolm R., Kappelle, L. Jaap, and Van der Worp, H. Bart
- Subjects
BRAIN blood-vessels ,MEDICAL research ,MEDICAL experimentation on humans ,CLINICAL trials ,EDEMA ,BODY fluid disorders - Abstract
Background: Patients with a hemispheric infarct and massive space-occupying brain oedema have a poor prognosis. Despite maximal conservative treatment, the case fatality rate may be as high as 80%, and most survivors are left severely disabled. Non-randomised studies suggest that decompressive surgery reduces mortality substantially and improves functional outcome of survivors. This study is designed to compare the efficacy of decompressive surgery to improve functional outcome with that of conservative treatment in patients with space-occupying supratentorial infarction Methods: The study design is that of a multi-centre, randomised clinical trial, which will include 112 patients aged between 18 and 60 years with a large hemispheric infarct with space-occupying oedema that leads to a decrease in consciousness. Patients will be randomised to receive either decompressive surgery in combination with medical treatment or best medical treatment alone. Randomisation will be stratified for the intended mode of conservative treatment (intensive care or stroke unit care). The primary outcome measure will be functional outcome, as determined by the score on the modified Rankin Scale, at one year. [ABSTRACT FROM AUTHOR]
- Published
- 2006
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14. PAIS: paracetamol (acetaminophen) in stroke; protocol for a randomized, double blind clinical trial. [ISCRTN 74418480].
- Author
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van Breda, Eric J, van der Worp, H Bart, van Gemert, H Maarten A, Algra, Ale, Kappelle, L Jaap, van Gijn, Jan, Koudstaal, Peter J, and Dippel, Diederik WJ
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CEREBROVASCULAR disease ,BRAIN diseases ,CLINICAL trials ,ACETAMINOPHEN ,ANTIPYRETICS - Abstract
Background: In patients with acute stroke, increased body temperature is associated with large lesion volumes, high case fatality, and poor functional outcome. A 1°C increase in body temperature may double the odds of poor outcome. Two randomized double-blind clinical trials in patients with acute ischemic stroke have shown that treatment with a daily dose of 6 g acetaminophen (paracetamol) results in a small but rapid and potentially worthwhile reduction of 0.3°C (95% CI: 0.1-0.5) in body temperature. We set out to test the hypothesis that early antipyretic therapy reduces the risk of death or dependency in patients with acute stroke, even if they are normothermic. Methods/design: Paracetamol (Acetaminophen) In Stroke (PAIS) is a randomized, double-blind clinical trial, comparing high-dose acetaminophen with placebo in 2500 patients. Inclusion criteria are a clinical diagnosis of hemorrhagic or ischemic stroke and the possibility to start treatment within 12 hours from onset of symptoms. The study will have a power of 86% to detect an absolute difference of 6% in the risk of death or dependency at three months, and a power of 72% to detect an absolute difference of 5%, at a 5% significance level. Discussion: This is a simple trial, with a drug that only has a small effect on body temperature in normothermic patients. However, when lowering body temperature with acetaminophen does have the expected effectiveness, 20 patients will have to be treated to prevent dependency or death in one. [ABSTRACT FROM AUTHOR]
- Published
- 2005
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15. Effect of paracetamol (acetaminophen) and ibuprofen on body temperature in acute ischemic stroke PISA, a phase II double-blind, randomized, placebo-controlled trial [ISRCTN98608690].
- Author
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Dippel, Diederik W. J., Van Breda, Eric J., Van Der Worp, H. Bart, Van Gemert, Maarten A., Meijer, Ron J., Kappelle, L. Jaap, and Koudstaal, Peter J.
- Subjects
ACETAMINOPHEN ,BODY temperature ,CEREBROVASCULAR disease ,RANDOMIZED controlled trials ,PATIENTS - Abstract
Background: Body temperature is a strong predictor of outcome in acute stroke. In a previous randomized trial we observed that treatment with high-dose acetaminophen (paracetamol) led to a reduction of body temperature in patients with acute ischemic stroke, even when they had no fever. The purpose of the present trial was to study whether this effect of acetaminophen could be reproduced, and whether ibuprofen would have a similar, or even stronger effect. Methods: Seventy-five patients with acute ischemic stroke confined to the anterior circulation were randomized to treatment with either 1000 mg acetaminophen, 400 mg ibuprofen, or placebo, given 6 times daily during 5 days. Treatment was started within 24 hours from the onset of symptoms. Body temperatures were measured at 2-hour intervals during the first 24 hours, and at 6-hour intervals thereafter. Results: No difference in body temperature at 24 hours was observed between the three treatment groups. However, treatment with high-dose acetaminophen resulted in a 0.3°C larger reduction in body temperature from baseline than placebo treatment (95% CI: 0.0 to 0.6 °C). Acetaminophen had no significant effect on body temperature during the subsequent four days compared to placebo, and ibuprofen had no statistically significant effect on body temperature during the entire study period. Conclusions: Treatment with a daily dose of 6000 mg acetaminophen results in a small, but potentially worthwhile decrease in body temperature after acute ischemic stroke, even in normothermic and subfebrile patients. Further large randomized clinical trials are needed to study whether early reduction of body temperature leads to improved outcome. [ABSTRACT FROM AUTHOR]
- Published
- 2003
16. PRECIOUS: PREvention of Complications to Improve OUtcome in elderly patients with acute Stroke-statistical analysis plan of a randomised, open, phase III, clinical trial with blinded outcome assessment.
- Author
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de Jonge, Jeroen C., Woodhouse, Lisa J., Reinink, Hendrik, van der Worp, H. Bart, Bath, Philip M., and PRECIOUS investigators
- Subjects
OLDER patients ,STROKE patients ,STATISTICS ,CLINICAL trials ,CEFTRIAXONE - Abstract
Rationale: Aspiration, infections, and fever are common in the first days after stroke, especially in older patients. The occurrence of these complications has been associated with an increased risk of death or dependency.Aims and Design: PREvention of Complications to Improve OUtcome in elderly patients with acute Stroke (PRECIOUS) is an international, multi-centre, 3 × 2 factorial, randomised, controlled, open-label clinical trial with blinded outcome assessment, which will assess whether prevention of aspiration, infections, or fever with metoclopramide, ceftriaxone, paracetamol, respectively, or any combination of these in the first 4 days after stroke onset improves functional outcome at 90 days in elderly patients with acute stroke.Discussion: This statistical analysis plan provides a technical description of the statistical methodology and unpopulated tables and figures. The paper is written prior to data lock and unblinding of treatment allocation.Trial Registration: ISRCTN registry ISRCTN82217627 . Registered on 22 September 2015. The trial was prospectively registered. [ABSTRACT FROM AUTHOR]- Published
- 2020
- Full Text
- View/download PDF
17. Apixaban versus Antiplatelet drugs or no antithrombotic drugs after anticoagulation-associated intraCerebral HaEmorrhage in patients with Atrial Fibrillation (APACHE-AF): study protocol for a randomised controlled trial.
- Author
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van Nieuwenhuizen, Koen M, van der Worp, H Bart, Algra, Ale, Kappelle, L Jaap, Rinkel, Gabriel J E, van Gelder, Isabelle C, Schutgens, Roger E G, Klijn, Catharina J M, and APACHE-AF investigators
- Abstract
Background: There is a marked lack of evidence on the optimal prevention of ischaemic stroke and other thromboembolic events in patients with non-valvular atrial fibrillation and a recent intracerebral haemorrhage during treatment with oral anticoagulation. These patients are currently treated with oral anticoagulants, antiplatelet drugs, or no antithrombotic treatment, depending on personal and institutional preferences. Compared with warfarin, the direct oral anticoagulant apixaban reduces the risk of stroke or systemic embolism, intracranial haemorrhage, and case fatality in patients with atrial fibrillation. Compared with aspirin, apixaban reduces the risk of stroke or systemic embolism in patients with atrial fibrillation, and has a similar risk of intracerebral haemorrhage. Novel oral anticoagulants have not been evaluated in patients with atrial fibrillation and a recent intracerebral haemorrhage. To inform a phase III trial, the phase II Apixaban versus Antiplatelet drugs or no antithrombotic drugs after anticoagulation-associated intraCerebral HaEmorrhage in patients with Atrial Fibrillation (APACHE-AF) trial aims to obtain estimates of the rates of vascular death or non-fatal stroke in patients with atrial fibrillation and a recent anticoagulation-associated intracerebral haemorrhage treated with apixaban and in those in whom oral anticoagulation is avoided.Methods/design: APACHE-AF is a phase II, multicentre, open-label, parallel-group, randomised clinical trial with masked outcome assessment. One hundred adults with a history of atrial fibrillation and a recent intracerebral haemorrhage during treatment with anticoagulation in whom clinical equipoise exists on the optimal stroke prevention strategy will be enrolled in 14 hospitals in The Netherlands. These patients will be randomly assigned in a 1:1 ratio to either apixaban or to avoiding oral anticoagulation. Patients in the control group may be treated with antiplatelet drugs at the discretion of the treating physician. The primary outcome is the composite of vascular death or non-fatal stroke during follow-up. We aim to include 100 patients in 2.5 years. All patients will be followed-up for the duration of the study, but at least for 1 year. Recruitment commenced in September 2014 and is ongoing. This trial is funded by the Dutch Heart Foundation (2012 T077) and ZonMW (015008048).Trial Registration: NTR4526 (16 April 2014). [ABSTRACT FROM AUTHOR]- Published
- 2015
- Full Text
- View/download PDF
18. Correction: PAIS: paracetamol (acetaminophen) in stroke; protocol for a randomized, double blind clinical trial. [ISCRTN74418480].
- Author
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den Hertog HM, van der Worp HB, van Gemert HM, Algra A, Kappelle LJ, van Gijn J, Koudstaal PJ, and Dippel DW
- Abstract
Background: The Paracetamol (Acetaminophen) In Stroke (PAIS) study is a phase III multicenter, double blind, randomized, placebo-controlled clinical trial of high-dose acetaminophen in patients with acute stroke. The trial compares treatment with a daily dose of 6 g acetaminophen, started within 12 hours after the onset of symptoms, with matched placebo. The purpose of this study is to assess whether treatment with acetaminophen for 3 days will result in improved functional outcome through a modest reduction in body temperature and prevention of fever.The previously planned statistical analysis based on a dichotomization of the scores on the modified Rankin Scale (mRS) may not make the most efficient use of the available baseline information. Therefore, the planned primary analysis of the PAIS study has been changed from fixed dichotomization of the mRS to a sliding dichotomy analysis., Methods: Instead of taking a single definition of good outcome for all patients, the definition is tailored to each individual patient's baseline prognosis on entry into the trial., Conclusion: The protocol change was initiated because of both advances in statistical approaches and to increase the efficiency of the trial by improving statistical power., Trial Registration: Current Controlled Trials [ISCRTN74418480].
- Published
- 2008
- Full Text
- View/download PDF
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