Comparison of Clopidogrel-based Antiplatelet Agent Treatment and Aspirin Plus Low Dose Rivaroxaban Therapy

NCT07796217 · tracked via the Priya Life Science South Korea tracker

Sponsor

Seoul National University Bundang Hospital

Phase

Phase 4

Started

2023-11-15

Last updated

2026-09-02

Condition(s) studied

Cardiac EventCoronary Artery DiseasePeripheral Artery DiseaseBleeding

Investigational drug(s) / intervention(s)

Aspirin and low-dose rivaroxabanClopidogrel with or without aspirin →

Aspirin and low-dose rivaroxaban: Combination of aspirin and low-dose rivaroxaban

Clopidogrel with or without aspirin: Clopidogrel-based SAPT or DAPT at the clinician's discretion

Study summary

The study aims to conduct a randomized controlled trial among adults aged 19 years or older who have experienced acute myocardial infarction at least one year prior, or who have other comorbidities such as peripheral arterial disease or multiple cardiovascular diseases, and have consented to participate in the study. Participants will be randomly assigned to either a group that maintains antiplatelet therapy with aspirin and clopidogrel or clopidogrel alone, or a group that maintains combined antiplatelet and anticoagulant therapy with aspirin and low-dose rivaroxaban in a 1:1 ratio. The study aims to demonstrate that maintaining clopidogrel-based antiplatelet therapy is not clinically inferior to maintaining combined therapy with aspirin and low-dose rivaroxaban.

Eligibility

Sex

ALL

Min age

19 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Patient oriented cardiac event — 36 months
All-cause death, any myocardial infarction, any stroke, any revascularization (coronary or peripheral disease), acute limb ischemia (including all major vascular amputations), any acute thromboembolism, and BARC classification ≥ 2

Trial sites (1)

Facility	City	Region	Status
Seoul National Universtiy Bundang Hospital	Seongnam-si	Gyeonggi-do	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07796217 on ClinicalTrials.gov ↗ ← All trials in South Korea