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

Phase 4

Recruiting

• Conditions: Percutaneous Coronary Intervention; Acute Coronary Syndrome; Coronary Artery Disease
• Interventions: Drug: Aspirin + Clopidogrel + Rivaroxaban; Drug: Aspirin + Clopidogrel

• Registration Number: NCT05638867
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-26
• Study First Submitted QC: 2022-12-05
• Study First Posted: 2022-12-06
• Study Start: 2023-11-25
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-14
• Last Update Posted: 2024-01-17
• Primary Completion: 2026-12
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3944

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 or 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Aspirin + Clopidogrel + Rivaroxaban	Triple Antithrombotic Therapy: Aspirin (12 months) + Clopidogrel (12 months) + Rivaroxaban (3 months)
Control Group	Aspirin + Clopidogrel	Dual Antiplatelet Therapy: Aspirin (12 months) + Clopidogrel (12 months)

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Systemic Embolism	12 months
Stroke	12 months
Ischemia-driven Revascularization	12 months
Stent Thrombosis	12 months
All-cause Death	12 months
Cardiac Death	12 months
Myocardial Infarction	12 months
Net Adverse Clinical Events	12 months	Composite events including MACCE and bleeding

Trial Locations

Locations (1)

Chinese Academy of Medical Sciences, Fuwai Hospital; 🇨🇳 Beijing, Beijing, China