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

NCT07511257 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 326

Last updated 2026-04-09

No results posted yet for this study

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.

Conditions

  • Coronary Artery Ectasia
  • Acute Coronary Syndromes (ACS)
  • STEMI - ST Elevation Myocardial Infarction
  • NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI)

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

Sponsors & Collaborators

  • Instituto Nacional de Cardiologia Ignacio Chavez

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-11
Primary Completion
2029-06-30
Completion
2029-06-30

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07511257 on ClinicalTrials.gov