Antithrombotic Therapy in Acute Coronary Syndromes and Coronary Artery Ectasia

• Status: Recruiting
• Trial end date: 2024-07-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
• Treatments: Aspirin; Clopidogrel; Rivaroxaban

Criteria

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.