NOAC Therapy Guided by PARIS Risk Score and D-dimer in Patients With ACS After PCI

• Status: Not yet recruiting
• Trial end date: 2027-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China National Center for Cardiovascular Diseases
• Treatments: Aspirin; Clopidogrel; Rivaroxaban

Criteria

Inclusion Criteria:

• Diagnosed with Acute Coronary Syndrome 1-7 days after initial symptom stabilization,

• Aged 18-65 years old,

• Elevated D-dimer levels (≥0.28 μg/ml) on admission,

• PARIS coronary thrombosis risk score ≥ 3 points,

• Received Percutaneous Coronary Intervention and not on non-oral anticoagulants,

• Indicated for dual antiplatelet medication

Exclusion Criteria:

• Platelet level below 90 x10^6

• Hemoglobin level is less than 11g/dL

• History of severe bleeding

• History of stroke/TIA

• Severe hepatic/renal insufficiency

• Indicated for anticoagulation