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

National Center for Cardiovascular Diseases

Status and phase: Enrolling; Phase 4

Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention; Acute Coronary Syndrome

Treatments: Drug: Aspirin + Clopidogrel + Rivaroxaban; Drug: Aspirin + Clopidogrel

Study type: Interventional

Funder types: Other

Identifiers

NCT05638867

NCRC2022003

Details and patient eligibility

About

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.

Enrollment: 3,944 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3,944 participants in 2 patient groups

Experimental Group

Experimental group

Description:

Triple Antithrombotic Therapy: Aspirin (12 months) + Clopidogrel (12 months) + Rivaroxaban (3 months)

Treatment:

Drug: Aspirin + Clopidogrel + Rivaroxaban

Control Group

Other group

Description:

Dual Antiplatelet Therapy: Aspirin (12 months) + Clopidogrel (12 months)

Treatment:

Drug: Aspirin + Clopidogrel