Search

Abstract Background Both severe stenosis and completed occlusion in internal carotid artery or its distal branches have been considered the main reasons of cerebral hypoperfusion, which contributes to the washout disturbances of embolism in low perfusion territories distal to stenosis. An aggravated hypoperfusion state in certain brain region may induce ischemic stroke and further cognitive decline. However, the effective medication for cerebral hypoperfusion is largely unsettled. Methods/design By using computed tomography perfusion (CTP) imaging, the trial will evaluate the effectiveness, safety and tolerability of hydroxyethyl starch (HES) 130/0.4 for patients with extra-/intra-cranial artery stenosis and cerebral hypoperfusion. From 5 neurological inpatient wards, 300 patients will be randomly recruited for administered routine medications plus intravascular volume therapies using the equal volume of HES 130/0.4 or 0.9% sodium chloride solution. Cerebral hypoperfusion state after 7-day intervention is the primary outcome measure. The secondary outcome measures includes, impaired renal function, abnormal heart function, hematological changes, neurological dysfunctions and cerebrovascular events in peri-intervention period and/or 3-month follow-up. The sample size will allow the detection of a two-sided 5% significance level between groups in the endpoint with a power of 80%. Discussion The trial would provide important efficacy and safety data on the intravascular administration of HES 130/0.4 in patients with unilateral cerebral hypoperfusion. The effects on kidney function, heart function, coagulation, neurological function and cerebralvascular events will be assessed. Trial registration ClinicalTrials.gov (Identifier: NCT01192581)

Background: Transient ischemic attack (TIA) or minor ischemic stroke represents the largest group of cerebrovascular disease, and those patients have a high risk of early recurrent stroke. Over decades, anticoagulation therapy has been used prudently in them for likely increasing the risk of intra-/extra-cranial hemorrhagic complications. However, recently rivaroxaban, a new oral anticoagulant, is proved to be as effective as traditional anticoagulants, while carrying significantly less risk of intracranial hemorrhage. Therefore, we assumed that patients may benefit from rivaroxaban if treated soon after TIA or minor stroke, and designed this adequately powered randomized study, TRACE.Methods and Design: The Treatment of Rivaroxaban versus Aspirin in Non-disabling Cerebrovascular Events (TRACE) study is a randomized, double-blind clinical trial with a target enrollment of 4400 patients. A 14-days regimen of rivaroxaban 10 mg daily or a 14-days regimen of aspirin 100 mg daily will be administrated to randomized participants with acute TIA or minor stroke, defined as National Institute of Health Stroke Scale scores ≤ 3. The primary efficacy end point is percentage of patients with any stroke (ischemic or hemorrhage) at 14 days. Study visits will be performed at the day of randomization, day 14 and day 90.Discussion: Even though the new oral anticoagulants seem to be both safe and effective, few clinical trials have been carried out to test their effect on non-disabling cerebrovascular events. Treatment with rivaroxaban may prevent more cerebrovascular events with an acceptable risk profile after TIA or minor stroke, compared with aspirin, thus helping to improve the outcome of the disease.Trial Registration: No. NCT01923818. [ABSTRACT FROM AUTHOR]