RECRUITINGPhase 4INTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Aspirin + Clopidogrel + Rivaroxaban

Triple antithrombotic therapy: aspirin 75-100 mg orally once daily, clopidogrel 75 mg orally once daily, and rivaroxaban 2.5 mg orally twice daily

DRUG

Aspirin + Clopidogrel

Dual antithrombotic therapy: aspirin 75-100 mg orally once daily, clopidogrel 75 mg orally once daily

Locations (1)

Chinese Academy of Medical Sciences, Fuwai Hospital

Beijing, Beijing Municipality, China