Actively Recruiting
Multicenter Trial of Antithrombotic Strategies in Acute Coronary Syndrome With Coronary Artery Ectasia
Led by Instituto Nacional de Cardiologia Ignacio Chavez · Updated on 2026-04-09
326
Participants Needed
1
Research Sites
172 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Multicenter Trial of Antithrombotic Strategies in Acute Coronary Syndrome With Coronary Artery Ectasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years, of either sex, hospitalized with acute coronary syndrome with or without ST-segment elevation
- Recent acute coronary syndrome within 7 days before enrollment, confirmed by clinical presentation and elevated high-sensitivity cardiac troponin
- Presence of coronary artery ectasia in the culprit coronary artery confirmed by two expert cardiologists and quantitative coronary angiography
- Identification of a culprit artery matching ECG territory or showing signs of atherothrombotic event
- Hospital admission lasting more than 24 hours
- Managed with percutaneous coronary intervention or medical therapy, including stent implantation, balloon angioplasty, or thrombus aspiration
- Ability and willingness to provide written informed consent and participate in the study
You will not qualify if you...
- Pregnant women
- Current need for temporary or long-term anticoagulation therapy at enrollment
- Severe chronic kidney disease, defined as KDIGO stage G4 or higher with eGFR below 30 mL/min/1.73 m²
- eGFR below 30 mL/min/1.73 m² at hospital discharge
- History of major bleeding, active bleeding, or high bleeding risk including gastrointestinal or intracranial hemorrhage
- Advanced heart failure with left ventricular ejection fraction below 30% plus either more than two hospitalizations or unplanned emergency visits for heart failure in the past year, or NYHA class III or IV symptoms despite optimal therapy within the last 3 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
Instituto Nacional de Cardiologia "Ignacio Chávez"
Mexico City, Tlalpan, Mexico, 14080
Actively Recruiting
Research Team
D
Direccion de Investigación Instituto Nacional de Cardiología
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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