NCT05638867

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

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,944 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Aspirin + Clopidogrel + Rivaroxaban	Triple antithrombotic therapy: aspirin 75-100 mg orally once daily, clopidogrel 75 mg orally once daily, and rivaroxaban 2.5 mg orally twice daily
DRUG	Aspirin + Clopidogrel	Dual antithrombotic therapy: aspirin 75-100 mg orally once daily, clopidogrel 75 mg orally once daily

Timeline

• Start date: 2023-11-25
• Primary completion: 2026-12-01
• Completion: 2027-01-01
• First posted: 2022-12-06
• Last updated: 2024-01-17

Locations

1 site across 1 country: China