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出境医 / 临床实验 / DUAL Antithrombotic Therapy in Patients With AF and ACS

DUAL Antithrombotic Therapy in Patients With AF and ACS

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Acute Coronary Syndromes Drug: Rivaroxaban 15 MG Oral Tablet Drug: Clopidogrel 75 Mg Oral Tablet Drug: Ticagrelor 90 MG Oral Tablet Phase 4

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: rivaroxaban plus ticagrelor
rivaroxaban 15 mg (or 10 mg for subjects with moderate renal impairment) once daily plus ticagrelor 90 mg tablet twice daily for 12 months
 Drug: Rivaroxaban 15 MG Oral Tablet
One 15 mg tablet once daily for up to twelve months
Other Name: Xarelto

Drug: Ticagrelor 90 MG Oral Tablet
One 90 mg tablet twice daily for up to twelve months
Other Name: P2Y12 antagonists
Active Comparator: rivaroxaban plus clopidogrel
rivaroxaban 15 mg (or 10 mg for subjects with moderate renal impairment) once daily plus clopidogrel 75 mg tablet once daily for 12 months
 Drug: Rivaroxaban 15 MG Oral Tablet
One 15 mg tablet once daily for up to twelve months
Other Name: Xarelto

Drug: Clopidogrel 75 Mg Oral Tablet
One 75 mg tablet once daily for up to twelve months
Other Name: P2Y12 antagonists
Outcome Measures
Primary Outcome Measures :
  1. The composite endpoints of death and ischemic events [ Time Frame: one year ]
    The composite endpoints of death and ischemic events (stroke, myocardial infarction, stent thrombosis, urgent revascularization )


Secondary Outcome Measures :
  1. Clinically significant bleeding [ Time Frame: one year ]
    Clinically significant bleeding is a composite of Thrombolysis in Myocardial Infarction (TIMI) major bleeding, minor bleeding, and bleeding requiring medical attention (BRMA)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Jun Jiang, PhD 13588706891 hu888po@126.com

Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
Layout table for investigator information
Study Director: Jun Jiang, PhD Second Affiliated Hospital Zhejiang University School of Medicine
Tracking Information
First Submitted Date  ICMJE July 16, 2019
First Posted Date  ICMJE July 17, 2019
Last Update Posted Date July 17, 2019
Estimated Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2019) 		The composite endpoints of death and ischemic events [ Time Frame: one year ]
The composite endpoints of death and ischemic events (stroke, myocardial infarction, stent thrombosis, urgent revascularization )
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2019) 		Clinically significant bleeding [ Time Frame: one year ]
Clinically significant bleeding is a composite of Thrombolysis in Myocardial Infarction (TIMI) major bleeding, minor bleeding, and bleeding requiring medical attention (BRMA)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DUAL Antithrombotic Therapy in Patients With AF and ACS
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Atrial Fibrillation
  • Acute Coronary Syndromes
Intervention  ICMJE
  • Drug: Rivaroxaban 15 MG Oral Tablet
    One 15 mg tablet once daily for up to twelve months
    Other Name: Xarelto
  • Drug: Clopidogrel 75 Mg Oral Tablet
    One 75 mg tablet once daily for up to twelve months
    Other Name: P2Y12 antagonists
  • Drug: Ticagrelor 90 MG Oral Tablet
    One 90 mg tablet twice daily for up to twelve months
    Other Name: P2Y12 antagonists
Study Arms  ICMJE
  • Experimental: rivaroxaban plus ticagrelor
    rivaroxaban 15 mg (or 10 mg for subjects with moderate renal impairment) once daily plus ticagrelor 90 mg tablet twice daily for 12 months
    Interventions:
    • Drug: Rivaroxaban 15 MG Oral Tablet
    • Drug: Ticagrelor 90 MG Oral Tablet
  • Active Comparator: rivaroxaban plus clopidogrel
    rivaroxaban 15 mg (or 10 mg for subjects with moderate renal impairment) once daily plus clopidogrel 75 mg tablet once daily for 12 months
    Interventions:
    • Drug: Rivaroxaban 15 MG Oral Tablet
    • Drug: Clopidogrel 75 Mg Oral Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 16, 2019) 		4000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2021
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jun Jiang, PhD 13588706891 hu888po@126.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04023630
Other Study ID Numbers  ICMJE SAHZJU CT013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jian'an Wang,MD,PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Sponsor  ICMJE Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jun Jiang, PhD Second Affiliated Hospital Zhejiang University School of Medicine
PRS Account Second Affiliated Hospital, School of Medicine, Zhejiang University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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