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

August 9, 2026 updated by: Jinqing Yuan, China National Center for Cardiovascular Diseases

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

3944

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100037
        • Recruiting
        • Chinese Academy of Medical Sciences, Fuwai Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Triple Antithrombotic Therapy: Aspirin (12 months) + Clopidogrel (12 months) + Rivaroxaban (3 months)
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
Other Names:
  • Triple Antithrombotic Therapy
Other: Control Group
Dual Antiplatelet Therapy: Aspirin (12 months) + Clopidogrel (12 months)
Drug: Aspirin + Clopidogrel
Dual antithrombotic therapy: aspirin 75-100 mg orally once daily, clopidogrel 75 mg orally once daily
Other Names:
  • Dual Antiplatelet Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time Frame: 12 months
Composite events including all-cause death, myocardial infarction, stroke, ischemia-driven revascularization, stent thrombosis, and systemic embolism
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause Death
Time Frame: 12 months
12 months
Cardiac Death
Time Frame: 12 months
12 months
Myocardial Infarction
Time Frame: 12 months
12 months
Stroke
Time Frame: 12 months
12 months
Ischemia-driven Revascularization
Time Frame: 12 months
12 months
Stent Thrombosis
Time Frame: 12 months
12 months
Systemic Embolism
Time Frame: 12 months
12 months
Net Adverse Clinical Events
Time Frame: 12 months
Composite events including MACCE and bleeding
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding
Time Frame: 12 months
BARC 3,5 bleeding events
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Investigators

  • Principal Investigator: Jinqing Yuan, MD, Chinese Academy of Medical Sciences, Fuwai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

November 26, 2022

First Submitted That Met QC Criteria

December 5, 2022

First Posted (Actual)

December 6, 2022

Study Record Updates

Last Update Posted (Actual)

August 11, 2026

Last Update Submitted That Met QC Criteria

August 9, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCRC2022003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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