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RECRUITING
NCT07511257
PHASE4

Multicenter Trial of Antithrombotic Strategies in Acute Coronary Syndrome With Coronary Artery Ectasia

Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez

View on ClinicalTrials.gov

Summary

Coronary artery ectasia (CAE) is a condition in which a coronary artery becomes abnormally dilated, measuring at least 50% larger than the adjacent normal segment. Although relatively uncommon, CAE is clinically important because it can lead to abnormal blood flow and increase the risk of blood clot formation. Patients with CAE are at higher risk of angina, myocardial infarction, and complications during coronary interventions. Despite these risks, the optimal antithrombotic treatment for patients with acute coronary syndrome (ACS) and CAE remains uncertain. Dual antiplatelet therapy (aspirin plus clopidogrel) is currently the most commonly used treatment. However, the abnormal blood flow patterns observed in CAE may promote clot formation through mechanisms that could potentially be better addressed with anticoagulant therapy. The OVER-TIME II trial is a multicenter randomized clinical trial designed to compare two antithrombotic strategies in patients with ACS and CAE: standard dual antiplatelet therapy versus antiplatelet monotherapy combined with anticoagulation. The study aims to determine whether the addition of anticoagulation reduces major cardiovascular events without significantly increasing bleeding risk.

Official title: Dual Antiplatelet Therapy Versus Antiplatelet Monotherapy Plus Anticoagulation in Patients With Acute Coronary Syndrome and Coronary Artery Ectasia: A Multicenter Randomized Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

326

Start Date

2026-02-11

Completion Date

2029-06

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

DRUG

Aspirin 100 mg

Participants receive aspirin 100 mg once daily

DRUG

Clopidogrel 75 mg

Participants receive clopidogrel 75 mg once daily

DRUG

Rivaroxaban 15 mg

Participants receive oral anticoagulation using rivaroxaban 15 mg once daily

Locations (1)

Instituto Nacional de Cardiologia "Ignacio Chávez"

Mexico City, Tlalpan, Mexico