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

Sponsor
China National Center for Cardiovascular Diseases (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05638867
Collaborator
(none)
3,944
Enrollment
1
Location
2
Arms
48
Anticipated Duration (Months)
82.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Aspirin + Clopidogrel + Rivaroxaban
  • Drug: Aspirin + Clopidogrel
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
3944 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Open-label, Two-arm, Randomized Superiority TrialOpen-label, Two-arm, Randomized Superiority Trial
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
This is an open-label study. But while the study is in progress, the grouping information is masked from investigators and outcome assessors (CEC).
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2026
Anticipated Study Completion Date :
Jan 1, 2027

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) [12 months]

      Composite events including all-cause death, myocardial infarction, stroke, ischemia-driven revascularization, stent thrombosis, and systemic embolism

    Secondary Outcome Measures

    1. All-cause Death [12 months]

    2. Cardiac Death [12 months]

    3. Myocardial Infarction [12 months]

    4. Stroke [12 months]

    5. Ischemia-driven Revascularization [12 months]

    6. Stent Thrombosis [12 months]

    7. Systemic Embolism [12 months]

    8. Net Adverse Clinical Events [12 months]

      Composite events including MACCE and bleeding

    Other Outcome Measures

    1. Bleeding [12 months]

      BARC 3,5 bleeding events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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,

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chinese Academy of Medical Sciences, Fuwai Hospital Beijing Beijing China 100037

    Sponsors and Collaborators

    • China National Center for Cardiovascular Diseases

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jinqing Yuan, Deputy Director of Coronary Heart Disease Center, Director of Ward 1, China National Center for Cardiovascular Diseases
    ClinicalTrials.gov Identifier:
    NCT05638867
    Other Study ID Numbers:
    • NCRC2022003
    First Posted:
    Dec 6, 2022
    Last Update Posted:
    Dec 6, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Keywords provided by Jinqing Yuan, Deputy Director of Coronary Heart Disease Center, Director of Ward 1, China National Center for Cardiovascular Diseases
    Novel Oral Anticoagulant
    PARIS risk score
    D-dimer
    Acute Coronary Syndrome
    Percutaneous Coronary Intervention
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Acute Coronary Syndrome
    Syndrome
    Aspirin
    Rivaroxaban
    Clopidogrel

    Study Results

    No Results Posted as of Dec 6, 2022