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

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

Recruiting
18-75 years
All
Phase 4

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Overview

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 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 or PARIS coronary thrombosis risk score ≥ 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

Study details
    Coronary Artery Disease
    Percutaneous Coronary Intervention
    Acute Coronary Syndrome

NCT05638867

China National Center for Cardiovascular Diseases

26 January 2024

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