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NCT Number: NCT05638867

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

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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Key information

Conditions

Coronary Artery Disease Acute Coronary Syndrome Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Percutaneous Coronary Intervention Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chinese Academy of Medical Sciences, Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

Location status: Recruiting

Location contact

Jinqing Yuan, MD

CONTACT

[email protected]

+86-10-68314466

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Triple Antithrombotic Therapy

Aspirin + clopidogrel

Drug

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

Other names: Dual Antiplatelet Therapy

Primary outcomes

  1. 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

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

  5. Ischemia-driven Revascularization

    Time frame: 12 months

  6. Stent Thrombosis

    Time frame: 12 months

  7. Systemic Embolism

    Time frame: 12 months

  8. Net Adverse Clinical Events

    Time frame: 12 months

    Composite events including MACCE and bleeding

Other outcomes

  1. Bleeding

    Time frame: 12 months

    BARC 3,5 bleeding events

Study contacts

Contact information is provided by the study sponsor or research team.

Jinqing Yuan, MD

CONTACT

[email protected]

+86-10-68314466

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Dec 6, 2022
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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