NOAC Therapy Guided by PARIS Risk Score and D-dimer in Patients With ACS After PCI
Study Details
Study Description
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:
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Whether the intervention is effective in reducing ischemic events
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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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Experimental Group Triple Antithrombotic Therapy: Aspirin (12 months) + Clopidogrel (12 months) + Rivaroxaban (3 months) |
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
Other Names:
|
Other: Control Group Dual Antiplatelet Therapy: Aspirin (12 months) + Clopidogrel (12 months) |
Drug: Aspirin + Clopidogrel
Dual antithrombotic therapy: aspirin 75-100 mg orally once daily, clopidogrel 75 mg orally once daily
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- All-cause Death [12 months]
- Cardiac Death [12 months]
- Myocardial Infarction [12 months]
- Stroke [12 months]
- Ischemia-driven Revascularization [12 months]
- Stent Thrombosis [12 months]
- Systemic Embolism [12 months]
- Net Adverse Clinical Events [12 months]
Composite events including MACCE and bleeding
Other Outcome Measures
- Bleeding [12 months]
BARC 3,5 bleeding events
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosed with Acute Coronary Syndrome 1-7 days after initial symptom stabilization,
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Aged 18-65 years old,
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Elevated D-dimer levels (≥0.28 μg/ml) on admission,
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PARIS coronary thrombosis risk score ≥ 3 points,
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Received Percutaneous Coronary Intervention and not on non-oral anticoagulants,
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Indicated for dual antiplatelet medication
Exclusion Criteria:
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Platelet level below 90 x10^6
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Hemoglobin level is less than 11g/dL
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History of severe bleeding
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History of stroke/TIA
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Severe hepatic/renal insufficiency
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Indicated for anticoagulation
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Chinese Academy of Medical Sciences, Fuwai Hospital | Beijing | Beijing | China | 100037 |
Sponsors and Collaborators
- China National Center for Cardiovascular Diseases
Investigators
- Principal Investigator: Jinqing Yuan, MD, Chinese Academy of Medical Sciences, Fuwai Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NCRC2022003