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

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.

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

Sponsors & Collaborators

• Korea University Guro Hospital

  collaborator OTHER

• Korea University Ansan Hospital

  collaborator OTHER

• Korea University Anam Hospital

  collaborator OTHER

• Chungnam National University Sejong Hospital

  collaborator OTHER

• National Health Insurance Service Ilsan Hospital

  collaborator OTHER

• Ewha Womans University Seoul Hospital

  collaborator OTHER

• Konyang University Hospital

  collaborator OTHER

• Seoul National University Hospital

  collaborator OTHER

• KangWon National University Hospital

  collaborator OTHER

• Sejong General Hospital

  collaborator OTHER

• Inha University Hospital

  collaborator OTHER

• Severance Hospital

  collaborator OTHER

• Myongji Hospital

  collaborator OTHER

• Chonnam National University Hospital

  collaborator OTHER

• Chungnam National University Hospital

  collaborator OTHER

• Jeju National University Hospital

  collaborator OTHER

• Kwangju christian hospital

  collaborator UNKNOWN

• Soonchunhyang University Hospital

  collaborator OTHER

• Wonju Severance Christian Hospital

  collaborator OTHER

• Seoul National University Bundang Hospital

  lead OTHER

Principal Investigators

• In-Ho Chae, M.D Ph.D · Seoul National University Bundang Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-15

Primary Completion

2027-06-30

Completion

2027-12-31

Countries

• South Korea

Study Locations