Antithrombotic options for acute coronary syndrome with coronary artery ectasia

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

This trial tests whether using rivaroxaban instead of the usual aspirin plus clopidogrel better prevents clot-related complications in adults hospitalized with acute coronary syndrome who have coronary artery ectasia.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 326 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez (other)
• Locations: 1 site (Mexico City, Tlalpan)
• Trial ID: NCT07511257 on ClinicalTrials.gov

What this trial studies

OVER-TIME II is a randomized multicenter Phase 4 trial comparing standard dual antiplatelet therapy (aspirin 100 mg plus clopidogrel 75 mg) with an anticoagulant strategy including rivaroxaban 15 mg in patients presenting with ACS and angiographically confirmed coronary artery ectasia. Eligible adults 18–80 years are enrolled within seven days of an ACS event and require confirmation of ectasia by two interventional cardiologists and quantitative coronary angiography. The trial tracks thrombotic events, recurrent myocardial infarction, procedure-related complications, and bleeding and other safety outcomes over the treatment and follow-up period. Treatments are administered during hospital admission with protocolized follow-up at the lead site.

Who should consider this trial

Good fit: Adults aged 18 to 80 hospitalized within seven days for STEMI or NSTEMI who have coronary artery ectasia confirmed by angiography and remain admitted for more than 24 hours.

Not a fit: Patients without coronary artery ectasia, those outside the 18–80 age range, or people with high bleeding risk or contraindications to anticoagulant or antiplatelet therapy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the approach could reduce heart attacks, distal embolization, and other clot-related complications in patients with ectatic coronary arteries compared with standard dual antiplatelet therapy.

How similar studies have performed: While anticoagulants have shown benefits in some acute coronary syndrome populations, randomized data specifically focused on patients with coronary artery ectasia are limited, so this approach builds on related evidence but remains relatively novel for CAE.

Eligibility criteria

Inclusion Criteria:

* Adults aged 18 to 80 years, of either sex, hospitalized with acute coronary syndrome (ACS) with or without ST-segment elevation.
* Recent ACS within 7 days prior to enrollment, defined by all of the following:
* Clinical presentation consistent with acute coronary syndrome.
* Elevated high-sensitivity cardiac troponin above the 99th percentile.
* Presence or absence of persistent ST-segment elevation.
* Coronary artery ectasia in the culprit coronary artery, defined by all of the following:
* The presence of ectasia will be determined by agreement of two expert interventional cardiologists, and will be confirmed by quantitative coronary angiography (QCA).
* Identification of a culprit artery consistent with the electrocardiographic territory involved (in cases with ST-segment elevation) or with angiographic features suggestive of an atherothrombotic event, such as the presence of thrombus or reduced coronary flow.
* Hospital admission lasting more than 24 hours.
* Management with either percutaneous coronary intervention or medical therapy, as determined by the treating medical team. Intracoronary interventions such as stent implantation, balloon angioplasty, or thrombus aspiration are permitted.
* Ability and willingness to provide written informed consent and to participate in the study.

Exclusion Criteria:

* Pregnant women.
* Current indication for temporary or long-term anticoagulation therapy at the time of enrollment.
* Severe chronic kidney disease, defined as KDIGO stage G4 or higher (estimated glomerular filtration rate \[eGFR\] \<30 mL/min/1.73 m²).
* Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m² at hospital discharge.
* History of major bleeding, active bleeding, or high bleeding risk, including but not limited to gastrointestinal bleeding, intracranial hemorrhage, or other conditions considered by the treating physician to confer a high risk of bleeding.
* Advanced heart failure, defined as left ventricular ejection fraction (LVEF) \<30% plus at least one of the following:
* More than two hospitalizations or unplanned emergency department visits for heart failure in the past year, or
* NYHA functional class III or IV symptoms despite optimal medical therapy at enrollment or within the previous 3 months.

Where this trial is running

Mexico City, Tlalpan

• Instituto Nacional de Cardiologia "Ignacio Chávez" — Mexico City, Tlalpan, Mexico (RECRUITING)

Study contacts

• Study coordinator: Direccion de Investigación Instituto Nacional de Cardiología

Conditions: Coronary Artery Ectasia, Acute Coronary Syndromes, STEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation Myocardial Infarction, Acute Coronary Syndrome, Anticoagulation, Dual Antiplatelet Therapy