Acute Coronary Syndrome Clinical Trial
— OVER-TIMEOfficial title:
A Randomized Controlled Trial of Dual Antiplatelet Therapy Versus Antiplatelet Monotherapy and Oral Anticoagulation in Patients With Acute Coronary Syndrome and Coronary Artery Ectasia: OVER-TIME
The optimal anti-thrombotic therapy to prevent recurrent ischemic events in patients with acute coronary syndrome and coronary artery ectasia (CAE) remains unclear. 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. The investigators aim to enroll 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. 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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | July 30, 2024 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - Informed consent obtained before any trial-related activities. - Hospitalized male or female aged >18 years. - First event of ACS (including both, ST- Segment Elevation or Non- ST Elevation Myocardial Infarction) with high sensitivity troponin T levels exceeding 99th percentile or segmental motion abnormalities by echocardiography. - Angiographic evidence of CAE involving the infarction culprit artery. - Hospital length of stay >24 hours. - Percutaneous revascularization or medical treatment according to the treating physician criteria. Exclusion Criteria: - Indication for temporary or permanent anticoagulation. - Relative or absolute contraindications to receive anticoagulation. - Chronic kidney disease (CKD) KDIGO > III or GFR <30 ml/min/1.73 m2 - Angiographic evidence of coronary aneurysms (saccular or fusiform) - Patients undergoing coronary artery bypass graft (CABG). - Left ventricular ejection fraction <40%. - History of major bleeding events. - Pregnant women. |
Country | Name | City | State |
---|---|---|---|
Mexico | Instituto Nacional de Cardiologia | Mexico City | |
Mexico | Instituto Nacional de Cardiología "Ignacio Chavez" | Mexico City |
Lead Sponsor | Collaborator |
---|---|
Instituto Nacional de Cardiologia Ignacio Chavez |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite of cardiovascular death, recurrent MI and repeated revascularization | Main efficacy combined outcome of cardiovascular death, recurrent MI and repeated revascularization | 1 year. | |
Primary | Composite of minor and major bleeding events. | Main safety combined outcome of minor and major events, measured by BARC scale. | 1 year | |
Secondary | Net clinical benefit composite endpoint, including cardiovascular death, recurrent MI, repeated revascularization and minor/major bleeding | Composite of cardiovascular death, recurrent MI, repeated revascularization and minor/major bleeding | 1 year | |
Secondary | Clot lysis time by turbidimetry | Time (in seconds) taken for turbidity to drop by 50% from maximum as a measure of lysis potential | 6 months |
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