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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

3944 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-25

Study Completion Date

2027-01-31

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.

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Detailed Description

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Conditions

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Coronary Artery Disease Percutaneous Coronary Intervention Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Open-label, Two-arm, Randomized Superiority Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

This is an open-label study. But while the study is in progress, the grouping information is masked from outcome assessors (CEC).

Study Groups

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Experimental Group

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

Group Type EXPERIMENTAL

Aspirin + Clopidogrel + Rivaroxaban

Intervention Type DRUG

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

Control Group

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

Group Type OTHER

Aspirin + Clopidogrel

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Aspirin + Clopidogrel

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

Intervention Type DRUG

Other Intervention Names

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Triple Antithrombotic Therapy Dual Antiplatelet Therapy

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 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No