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

Phase 4RecruitingNCT05638867

China National Center for Cardiovascular Diseases3,944 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

3,944

Conditions

Coronary Artery Disease Percutaneous Coronary Intervention Acute Coronary Syndrome

Aspirin + Clopidogrel + RivaroxabanDRUG

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

Aspirin + ClopidogrelDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with Acute Coronary Syndrome 1-7 days after initial symptom stabilization, * Aged 18-75 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

Outcomes

Primary Outcomes

Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)

Composite events including all-cause death, myocardial infarction, stroke, ischemia-driven revascularization, stent thrombosis, and systemic embolism

Time frame: 12 months

Secondary Outcomes

All-cause Death

Time frame: 12 months

Cardiac Death

Time frame: 12 months

Myocardial Infarction

Time frame: 12 months

Stroke

Time frame: 12 months

Ischemia-driven Revascularization

Time frame: 12 months

Stent Thrombosis

Time frame: 12 months

Systemic Embolism

Time frame: 12 months

Net Adverse Clinical Events

Composite events including MACCE and bleeding

Time frame: 12 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts