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DUAL Antithrombotic Therapy in Patients With AF and ACS

Primary Purpose

Atrial Fibrillation, Acute Coronary Syndromes

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Rivaroxaban 15 MG Oral Tablet
Clopidogrel 75 Mg Oral Tablet
Ticagrelor 90 MG Oral Tablet
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adults with either active or a history of non-valvular atrial fibrillation or flutter with the planned or existing use of an oral anticoagulant for prophylaxis of thromboembolism. In addition, subjects must have had an acute coronary syndrome
  2. Planned use of antiplatelet agents for at least 12 months
  3. Males and Females ≥ 18 years of age
  4. Women of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug

Exclusion Criteria:

  1. Conditions other than atrial fibrillation that require chronic anticoagulation. (e.g. prosthetic mechanical heart valve)
  2. Severe renal insufficiency (serum creatinine > 2.5 mg/dL or a calculated creatinine clearance < 30 mL/min
  3. Patients with a history of intracranial hemorrhage
  4. Patients have had or will undergo Coronary arterial bypass graft (CABG) for their index acute coronary syndrome (ACS) event
  5. Patients with known ongoing bleeding and patients with known coagulopathies
  6. Any contraindications or allergies to rivaroxaban, or to intended P2Y12 antagonists
  7. Have a history of stroke or Transient Ischemic Attack (TIA)
  8. Have known significant liver disease or liver function test (LFT) abnormalities
  9. Have any severe condition that would limit life expectancy to less than 12 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    rivaroxaban plus ticagrelor

    rivaroxaban plus clopidogrel

    Arm Description

    rivaroxaban 15 mg (or 10 mg for subjects with moderate renal impairment) once daily plus ticagrelor 90 mg tablet twice daily for 12 months

    rivaroxaban 15 mg (or 10 mg for subjects with moderate renal impairment) once daily plus clopidogrel 75 mg tablet once daily for 12 months

    Outcomes

    Primary Outcome Measures

    The composite endpoints of death and ischemic events
    The composite endpoints of death and ischemic events (stroke, myocardial infarction, stent thrombosis, urgent revascularization )

    Secondary Outcome Measures

    Clinically significant bleeding
    Clinically significant bleeding is a composite of Thrombolysis in Myocardial Infarction (TIMI) major bleeding, minor bleeding, and bleeding requiring medical attention (BRMA)

    Full Information

    First Posted
    July 16, 2019
    Last Updated
    July 16, 2019
    Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04023630
    Brief Title
    DUAL Antithrombotic Therapy in Patients With AF and ACS
    Official Title
    An Open-label, Randomized, Controlled, Multicenter Study to Evaluate DUAL Antithrombotic Therapy With Rivaroxaban Plus Ticagrelor vs. Rivaroxaban Plus Clopidogrel in Patients With Atrial Fibrillation and Acute Coronary Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2019 (Anticipated)
    Primary Completion Date
    September 30, 2020 (Anticipated)
    Study Completion Date
    September 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The study aims to show inferiority of rivaroxaban plus ticagrelor when compared to rivaroxaban plus clopidogrel in terms of safety. Safety will be determined by comparing the rates of death or ischemic event-including myocardial infarction, definite or probable stent thrombosis, stroke, or urgent revascularization.
    Detailed Description
    The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of rivaroxaban plus ticagrelor with rivaroxaban plus clopidogrel in Patients With Non Valvular Atrial Fibrillation (NVAF) and Acute Coronary Syndrome. The study aims to show inferiority of rivaroxaban plus ticagrelor when compared to rivaroxaban plus clopidogrel in terms of safety. Safety will be determined by comparing the rates of death or ischemic event-including myocardial infarction, definite or probable stent thrombosis, stroke, or urgent revascularization.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation, Acute Coronary Syndromes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    4000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    rivaroxaban plus ticagrelor
    Arm Type
    Experimental
    Arm Description
    rivaroxaban 15 mg (or 10 mg for subjects with moderate renal impairment) once daily plus ticagrelor 90 mg tablet twice daily for 12 months
    Arm Title
    rivaroxaban plus clopidogrel
    Arm Type
    Active Comparator
    Arm Description
    rivaroxaban 15 mg (or 10 mg for subjects with moderate renal impairment) once daily plus clopidogrel 75 mg tablet once daily for 12 months
    Intervention Type
    Drug
    Intervention Name(s)
    Rivaroxaban 15 MG Oral Tablet
    Other Intervention Name(s)
    Xarelto
    Intervention Description
    One 15 mg tablet once daily for up to twelve months
    Intervention Type
    Drug
    Intervention Name(s)
    Clopidogrel 75 Mg Oral Tablet
    Other Intervention Name(s)
    P2Y12 antagonists
    Intervention Description
    One 75 mg tablet once daily for up to twelve months
    Intervention Type
    Drug
    Intervention Name(s)
    Ticagrelor 90 MG Oral Tablet
    Other Intervention Name(s)
    P2Y12 antagonists
    Intervention Description
    One 90 mg tablet twice daily for up to twelve months
    Primary Outcome Measure Information:
    Title
    The composite endpoints of death and ischemic events
    Description
    The composite endpoints of death and ischemic events (stroke, myocardial infarction, stent thrombosis, urgent revascularization )
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    Clinically significant bleeding
    Description
    Clinically significant bleeding is a composite of Thrombolysis in Myocardial Infarction (TIMI) major bleeding, minor bleeding, and bleeding requiring medical attention (BRMA)
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    95 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adults with either active or a history of non-valvular atrial fibrillation or flutter with the planned or existing use of an oral anticoagulant for prophylaxis of thromboembolism. In addition, subjects must have had an acute coronary syndrome Planned use of antiplatelet agents for at least 12 months Males and Females ≥ 18 years of age Women of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug Exclusion Criteria: Conditions other than atrial fibrillation that require chronic anticoagulation. (e.g. prosthetic mechanical heart valve) Severe renal insufficiency (serum creatinine > 2.5 mg/dL or a calculated creatinine clearance < 30 mL/min Patients with a history of intracranial hemorrhage Patients have had or will undergo Coronary arterial bypass graft (CABG) for their index acute coronary syndrome (ACS) event Patients with known ongoing bleeding and patients with known coagulopathies Any contraindications or allergies to rivaroxaban, or to intended P2Y12 antagonists Have a history of stroke or Transient Ischemic Attack (TIA) Have known significant liver disease or liver function test (LFT) abnormalities Have any severe condition that would limit life expectancy to less than 12 months
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jun Jiang, PhD
    Phone
    13588706891
    Email
    hu888po@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jun Jiang, PhD
    Organizational Affiliation
    Second Affiliated Hospital Zhejiang University School of Medicine
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    DUAL Antithrombotic Therapy in Patients With AF and ACS

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