Antithrombotic options for acute coronary syndrome with coronary artery ectasia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Instituto Nacional de Cardiologia "Ignacio Chávez"
  Mexico City, Tlalpan, Mexico Recruiting

Study contacts

• Study coordinator: Direccion de Investigación Instituto Nacional de Cardiología
• Email: comite.investigacion@cardiologia.org.mx
• Phone: +52 5555732911

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.