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RECRUITING

NCT07796217

PHASE4

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

Sponsor: Seoul National University Bundang Hospital

View on ClinicalTrials.gov

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.

Official title: Optimal Strategy for Treatment of Atherosclerotic Cardiovascular Disease - Comparison of Clopidogrel-based Antiplatelet Agent Treatment Versus Aspirin Plus Low Dose Rivaroxaban Therapy

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2758

Start Date

2023-11-15

Completion Date

2027-12-31

Last Updated

2026-09-02

Healthy Volunteers

Conditions

Cardiac Event Coronary Artery Disease Peripheral Artery Disease Bleeding

Interventions

DRUG

Aspirin and low-dose rivaroxaban

Combination of aspirin and low-dose rivaroxaban

DRUG

Clopidogrel with or without aspirin

Clopidogrel-based SAPT or DAPT at the clinician's discretion

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

Locations (1)

Seoul National Universtiy Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea