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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Coronary Artery Disease, Percutaneous Coronary Intervention, Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Aspirin + Clopidogrel + Rivaroxaban
* Drug: Aspirin + Clopidogrel


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open-label, Two-arm, Randomized Superiority Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Triple Antithrombotic Therapy: Aspirin (12 months) + Clopidogrel (12 months) + Rivaroxaban (3 months) | Drug: Aspirin + Clopidogrel + Rivaroxaban<br>* Triple antithrombotic therapy: aspirin 75-100 mg orally once daily, clopidogrel 75 mg orally once daily, and rivaroxaban 2.5 mg orally twice daily<br>* Other names: Triple Antithrombotic Therapy;|
| Other: Control Group<br>Dual Antiplatelet Therapy: Aspirin (12 months) + Clopidogrel (12 months) | Drug: Aspirin + Clopidogrel<br>* Dual antithrombotic therapy: aspirin 75-100 mg orally once daily, clopidogrel 75 mg orally once daily<br>* Other names: Dual Antiplatelet Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | Composite events including all-cause death, myocardial infarction, stroke, ischemia-driven revascularization, stent thrombosis, and systemic embolism | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause Death |  | 12 months | 
| Cardiac Death |  | 12 months | 
| Myocardial Infarction |  | 12 months | 
| Stroke |  | 12 months | 
| Ischemia-driven Revascularization |  | 12 months | 
| Stent Thrombosis |  | 12 months | 
| Systemic Embolism |  | 12 months | 
| Net Adverse Clinical Events | Composite events including MACCE and bleeding | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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D-dimer, Novel Oral Anticoagulant, PARIS risk score, Acute Coronary Syndrome, Percutaneous Coronary Intervention