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

ConditionsCoronary Artery DiseasePercutaneous Coronary InterventionAcute Coronary Syndrome
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChina National Center for Cardiovascular Diseases

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

Platelet level below 90 x10^6

Hemoglobin level is less than 11g/dL

History of severe bleeding

History of stroke/TIA

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aspirin + Clopidogrel + Rivaroxaban

    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

  • Aspirin + Clopidogrel

    Drug

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

Treatment groups

3,944 Participants
are divided into 2 treatment groups
Group A: Experimental GroupExperimental treatment 1 intervention
Group B: Control GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

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

1

All-cause Death

Time frame
12 months
2

Cardiac Death

Time frame
12 months
3

Myocardial Infarction

Time frame
12 months
4

Stroke

Time frame
12 months

Other outcomes

1

Bleeding

BARC 3,5 bleeding events

Time frame
12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China National Center for Cardiovascular Diseases

Lead sponsor

Source ClinicalTrials.gov
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