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Recruiting NCT05638867

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

Phase IV Interventional Coronary Artery Disease Percutaneous Coronary Intervention Acute Coronary Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aspirin + Clopidogrel + Rivaroxaban, Aspirin + Clopidogrel.
Who it may be relevant to
Registry conditions: Coronary Artery Disease, Percutaneous Coronary Intervention, Acute Coronary Syndrome. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • Drug 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
  • Drug Aspirin + Clopidogrel
    Dual antithrombotic therapy: aspirin 75-100 mg orally once daily, clopidogrel 75 mg orally once daily

Primary outcome measures

  • Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) [Time frame: 12 months]
Secondary outcome measures (8)
  • 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 [Time frame: 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Chinese Academy of Medical Sciences, Fuwai Hospital — Beijing

Publications

  • Jia S, Song Y, Yuan D, Wang P, Xu J, Chen Y, Zhang C, Zhao X, Yuan JQ. 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: study protocol for the PRIDE-ACS trial. BMJ Open. 2025 May 15;15(5):e090126. doi: 10.1136/bmjopen-2024-090126. PMID 40379336

Identifiers

NCT: NCT05638867 · NCRC2022003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗