Antiplatelet-Only versus Antiplatelet plus Low-Dose Rivaroxaban after Heart Events

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

This randomized, interventional Phase 4 trial compares two antithrombotic strategies in adults who had an acute myocardial infarction more than a year ago or have related vascular diseases. Participants are assigned to either clopidogrel-based therapy with or without aspirin, versus a combination of aspirin plus low-dose rivaroxaban with clopidogrel. The aim is to determine if the clopidogrel strategy is not clinically inferior to the aspirin plus rivaroxaban approach in preventing thrombotic events while monitoring bleeding risk. The study addresses long-term management of thrombotic risk after coronary and peripheral vascular disease, balancing ischemic protection against bleeding. Enrollment focuses on older adults with multivessel CAD and peripheral arterial disease, under careful safety monitoring.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients over 65 years of age who have experienced acute myocardial infarction and have multivessel coronary artery disease (CAD) that has been present for over one year
* Patients who have peripheral arterial disease (history of PTA or bypass, history of foot/leg amputation, intermittent claudication with ABI \<0.9 or over 50% stenosis in peripheral arteries, or over 50% stenosis in coronary arteries or previous coronary stent implantation) and have a history of acute myocardial infarction for over one year or have one of the two conditions: multivessel CAD.
* Subject is able to verbally confirm understandings of risks, benefits and treatment, and he/she or his/her legally authorized representative provides written informed consent prior to study

Exclusion Criteria:

* History of serious hypersensitivity reactions to aspirin, clopidogrel, or prasugrel.
* Patients with coagulation disorders or liver diseases related to coagulation, as well as patients with moderate (Child Pugh B) and severe (Child Pugh C) liver dysfunction.
* Severe renal impairment with a creatinine clearance less than 15 mL/min.
* Patients who require long-term combination therapy with other anticoagulants such as unfractionated heparin (UFH), low molecular weight heparin (enoxaparin, dalteparin, etc.), heparinoids (fondaparinux, etc.), oral anticoagulants (warfarin, apixaban, dabigatran, etc.).
* In cases of active clinical bleeding at the time of study registration.
* Patients who require discontinuation of antiplatelet therapy for more than 3 months due to surgery or procedure
* Individuals with an expected lifespan of less than 3 years due to reasons other than cardiovascular disease.
* Concomitant use of the following contraindicated drugs: other P2Y12 inhibitors (prasugrel or ticagrelor); cytochrome P450 2C19 inhibitors (fluoxetine, fluvoxamine, or voriconazole); probenecid; high-dose methotrexate (≥15 mg/week); lithium.
* Pregnant or breastfeeding women.
* Inability to provide informed consent

Where it's running

• Seoul National Universtiy Bundang Hospital
  Seongnam-si, Gyeonggi-do, South Korea Recruiting

Study contacts

• Principal investigator: In-Ho Chae, M.D Ph.D — Seoul National University Bundang Hospital
• Study coordinator: Ju Seung Kwun, M.D
• Email: jkwun0413@gmail.com
• Phone: +82 31 787 7841

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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.