Back to Search
Start Over
Dual Antiplatelet Therapy Versus Antiplatelet Monotherapy Plus Oral Anticoagulation in Patients with Acute Coronary Syndrome and Coronary Artery Ectasia: Design and Rationale of OVER-TIME Randomized Clinical Trial.
- Source :
-
High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension [High Blood Press Cardiovasc Prev] 2022 Sep; Vol. 29 (5), pp. 463-468. Date of Electronic Publication: 2022 Jul 29. - Publication Year :
- 2022
-
Abstract
- Introduction: The optimal anti-thrombotic therapy to prevent recurrent ischemic events in patients with acute coronary syndrome and coronary artery ectasia (CAE) remains unclear.<br />Aim: To assess the efficacy and safety of antiplatelet plus anticoagulant therapy versus dual antiplatelet therapy in patients with acute coronary syndromes and coronary artery ectasia.<br />Methods: OVER-TIME is an investigator initiated, exploratory, open label, single center, randomized clinical trial comparing dual antiplatelet therapy (acetyl-salicylic acid plus a P2Y12 inhibitor) with the combination of an antiplatelet monotherapy (a P2Y12 inhibitor) plus a low dose anticoagulant (rivaroxaban, 15mg oral dose) for the prevention of recurrent ischemic events among patients with CAE. We aim to enroll approximately 60 patients with CAE and acute coronary syndromes. After recruitment, patients are randomized to (a) standard of care (dual antiplatelet regimen) or (b) the combination of antiplatelet monotherapy and low dose anticoagulant. Patients will be followed for at least 12 months. The OVER-TIME study aims to assess the efficacy of the regimen in prevention of major cardiovascular events and its security in bleeding events in acute coronary syndromes among patients with CAE. Expected results and conclusions: OVER-TIME is the first randomized controlled trial to assess different antithrombotic strategies in patients with CAE and acute coronary syndrome, and its results will offer preliminary data for the prevention of major cardiovascular events and bleeding events in this group of patients.<br />Trial Registration Number: NCT05233124 (ClinicalTrials.gov), date of registration: February 10, 2022.<br /> (© 2022. Italian Society of Hypertension.)
- Subjects :
- Anticoagulants adverse effects
Coronary Vessels
Dilatation, Pathologic chemically induced
Dilatation, Pathologic drug therapy
Drug Therapy, Combination
Fibrinolytic Agents adverse effects
Hemorrhage chemically induced
Humans
Platelet Aggregation Inhibitors adverse effects
Rivaroxaban
Salicylic Acid therapeutic use
Treatment Outcome
Acute Coronary Syndrome diagnosis
Acute Coronary Syndrome drug therapy
Percutaneous Coronary Intervention adverse effects
Percutaneous Coronary Intervention methods
Subjects
Details
- Language :
- English
- ISSN :
- 1179-1985
- Volume :
- 29
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension
- Publication Type :
- Academic Journal
- Accession number :
- 35904750
- Full Text :
- https://doi.org/10.1007/s40292-022-00535-4