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
China National Center for Cardiovascular Diseases
3,944 participants
Nov 25, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria6
- 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
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Interventions
Triple antithrombotic therapy: aspirin 75-100 mg orally once daily, clopidogrel 75 mg orally once daily, and rivaroxaban 2.5 mg orally twice daily
Dual antithrombotic therapy: aspirin 75-100 mg orally once daily, clopidogrel 75 mg orally once daily
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05638867