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NCT05638867
NOAC Therapy Guided by PARIS Risk Score and D-dimer in Patients With ACS After PCI
Conditions: Coronary Artery Disease, Percutaneous Coronary Intervention, Acute Coronary Syndrome
Sex: All
Ages: 18 Years – 65 Years
Phase: PHASE3
Enrollment: 3944
Sponsor: China National Center for Cardiovascular Diseases
Location: China
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 eventsWhether the intervention is safe from increasing bleeding events, especially severe or fatal onesParticipants 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 Criteria
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,PARIS coronary thrombosis risk score ≥ 3 points,Received Percutaneous Coronary Intervention and not on non-oral anticoagulants,Indicated for dual antiplatelet medicationExclusion Criteria:Platelet level below 90 x10^6Hemoglobin level is less than 11g/dLHistory of severe bleedingHistory of stroke/TIASevere hepatic/renal insufficiencyIndicated for anticoagulation
Source: ClinicalTrials.gov (NCT05638867). StuddyBuddy aggregates publicly available trial information.