A Randomized Controlled Clinical Trial of PARIS Coronary Thrombosis Risk Score Combined With D-dimer to Guide New Oral Anticoagulant Antithrombotic Therapy in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention

NCT05638867 Phase 4 RECRUITING

The goal of this clinical trial is to compare short-term Triple Antithrombotic Therapy (DAPT + Rivaroxaban) followed by DAPT with standard DAPT in selected ACS patients with high ischemic risk. The main questions it aims to answer are: * Whether the intervention is effective in reducing ischemic events * Whether the intervention is safe from increasing bleeding events, especially severe or fatal ones Participants will be randomized to receive standard DAPT therapy for the entire study duration or low-dose rivaroxaban+DAPT for 3 months, followed by standard DAPT for the rest of the study duration. Patients enrolled should complete 5 follow-ups in the form of clinic visit or telephone call.

Details

Lead sponsor	China National Center for Cardiovascular Diseases
Phase	Phase 4
Status	RECRUITING
Enrolment	3944
Start date	2023-11-25
Completion	2027-01

Conditions

• Coronary Artery Disease
• Percutaneous Coronary Intervention
• Acute Coronary Syndrome

Interventions

• Aspirin + Clopidogrel + Rivaroxaban
• Aspirin + Clopidogrel

Primary outcomes

• Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) — 12 months
  Composite events including all-cause death, myocardial infarction, stroke, ischemia-driven revascularization, stent thrombosis, and systemic embolism

Countries

China