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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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

Locations
Other Locations
China
Chinese Academy of Medical Sciences, Fuwai Hospital
RECRUITING
Beijing
Contact Information
Primary
Jinqing Yuan, MD
dr_jinqingyuan@sina.com
+86-10-68314466
Time Frame
Start Date: 2023-11-25
Estimated Completion Date: 2027-01
Participants
Target number of participants: 3944
Treatments
Experimental: Experimental Group
Triple Antithrombotic Therapy: Aspirin (12 months) + Clopidogrel (12 months) + Rivaroxaban (3 months)
Other: Control Group
Dual Antiplatelet Therapy: Aspirin (12 months) + Clopidogrel (12 months)
Sponsors
Leads: China National Center for Cardiovascular Diseases

This content was sourced from clinicaltrials.gov

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