drugset / Trial / NCT05638867

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

NCT05638867

Phase 4 Recruiting 3944 enrolled China National Center for Cardiovascular Diseases
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2023-11-25
Primary completion
2026-12
Completion
2027-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Rivaroxaban Other / unclassified 2.5 mg Oral
Background Aspirin Small molecule 75 mg Oral
Background Aspirin Small molecule 100 mg Oral
Background Clopidogrel Small molecule 75 mg Oral