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NOAC Therapy Guided by PARIS Risk Score and D-dimer in Patients With ACS After PCI

RecruitingPhase 4Ages 18 Years - 75 YearsAllChina National Center for Cardiovascular Diseases
NCT05638867 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Diagnosed with Acute Coronary Syndrome 1-7 days after initial symptom stabilization, * Aged 18-75 years old, * Elevated D-dimer levels (โ‰ฅ0.28 ฮผg/ml) on admission or PARIS coronary thrombosis risk score โ‰ฅ 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
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What it tests

  • Aspirin + Clopidogrel + Rivaroxaban
  • Aspirin + Clopidogrel
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Where

1 site
Chinese Academy of Medical Sciences, Fuwai Hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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