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
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 3,944
- Locations
- 1
- Primary Endpoint
- Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
This is an open-label study. But while the study is in progress, the grouping information is masked from outcome assessors (CEC).
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosed with Acute Coronary Syndrome 1-7 days after initial symptom stabilization,
- •Aged 18-75 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
Arms & Interventions
Control Group
Dual Antiplatelet Therapy: Aspirin (12 months) + Clopidogrel (12 months)
Intervention: Aspirin + Clopidogrel (Drug)
Experimental Group
Triple Antithrombotic Therapy: Aspirin (12 months) + Clopidogrel (12 months) + Rivaroxaban (3 months)
Intervention: Aspirin + Clopidogrel + Rivaroxaban (Drug)
Outcomes
Primary Outcomes
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time Frame: 12 months
Composite events including all-cause death, myocardial infarction, stroke, ischemia-driven revascularization, stent thrombosis, and systemic embolism
Secondary Outcomes
- 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)
- Systemic Embolism(12 months)
- Net Adverse Clinical Events(12 months)
Investigators
Jinqing Yuan
Deputy Director of Coronary Heart Disease Center, Director of Ward 1
China National Center for Cardiovascular Diseases