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Study to Assess Safety and Efficacy of Ticagrelor (AZD6140) Versus Clopidogrel in Asian/Japanese Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS)

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ClinicalTrials.gov Identifier: NCT01294462
Recruitment Status : Completed
First Posted : February 11, 2011
Results First Posted : May 2, 2014
Last Update Posted : June 27, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE February 10, 2011
First Posted Date  ICMJE February 11, 2011
Results First Submitted Date  ICMJE July 10, 2013
Results First Posted Date  ICMJE May 2, 2014
Last Update Posted Date June 27, 2014
Study Start Date  ICMJE February 2011
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2014)
  • Major Bleeding [ Time Frame: Ongoing up to12 months ]
    Time to first occurrence of any major bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)). 1-year event rate (%) estimated via Kaplan-Meier method.
  • Major Adverse Cardiac Events (MACE) [ Time Frame: Ongoing up to 12 months ]
    Time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke (adjudicated by an ICEC). 1-year event rate (%) estimated via Kaplan-Meier method.
Original Primary Outcome Measures  ICMJE
 (submitted: February 10, 2011)
  • To assess the safety of Ticagrelor (AZD6140) compared to Clopidogrel by measuring the time to first occurrence of any total major bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)) [ Time Frame: Ongoing up to12 months ]
  • Evaluate the effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke (adjudicated by an ICEC). [ Time Frame: Ongoing up to 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2014)
  • Major and Minor Bleeding [ Time Frame: Ongoing up to12 months ]
    Time to first occurrence of any major or minor bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)). 1-year event rate (%) estimated via Kaplan-Meier method.
  • Composite of All-cause Mortality, MI or Stroke [ Time Frame: Ongoing up to 12 months ]
    Time to first occurrence of any event from the composite of death from any causes, Myocardial Infarction (MI) and stroke (adjudicated by an ICEC). 1-year event rate (%) estimated via Kaplan-Meier method.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2011)
  • To assess the safety of Ticagrelor (AZD6140) compared to Clopidogrel by measuring the total number of bleeding events (including major, minor and minimal bleedings) [ Time Frame: Ongoing up to 12 months ]
  • To evaluate the effect of Ticagrelor (AZD6140) compared to Clopidogrel by assessing number of Adverse events (AEs), laboratory values, physical examination, electrocardiography (12-lead ECG), Holter ECG and vital signs. [ Time Frame: Ongoing up to 12 months ]
  • To evaluate the effect of Ticagrelor (AZD6140) compared to Clopidogrel by assessing the time to first occurrence of any event from the composite of all-cause mortality, MI or stroke [ Time Frame: Ongoing up to 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess Safety and Efficacy of Ticagrelor (AZD6140) Versus Clopidogrel in Asian/Japanese Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS)
Official Title  ICMJE A Randomised, Double-blind, Double-dummy, Parallel Group, International (Asian), Multicenter, Phase 3 Study to Assess Safety and Efficacy of AZD6140 on Top of Low Dose Acetyl Salicylic Acid (ASA) Versus Clopidogrel on Top of Low Dose ASA in Asian/Japanese Patients With Non-ST or ST Elevation Acute Coronary Syndromes(ACS) for Whom PCI is Planned
Brief Summary The purpose of the study is to assess the efficacy (prevention of vascular events) and safety (especially bleedings) of Ticagrelor (AZD6140) compared with Clopidogrel, both given on top of low dose aspirin, in Asian/Japanese patients with acute coronary syndrome and a planned percutaneous coronary intervention (PCI).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Coronary Syndrome
  • Percutaneous Coronary Intervention
Intervention  ICMJE
  • Drug: Ticagrelor
    90 mg, oral dose twice daily
    Other Name: AZD6140
  • Drug: Clopidogrel
    75 mg, oral dose once daily
    Other Name: Plavix
  • Drug: Acetylsalicylic acid ASA
    Low Dose ASA
Study Arms  ICMJE
  • Experimental: 1
    Ticagrelor (AZD6140)
    Interventions:
    • Drug: Ticagrelor
    • Drug: Acetylsalicylic acid ASA
  • Active Comparator: 2
    Clopidogrel
    Interventions:
    • Drug: Clopidogrel
    • Drug: Acetylsalicylic acid ASA
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 Completed
Actual Enrollment  ICMJE
 (submitted: March 31, 2014)
801
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2011)
800
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Provision of signed informed consent
  • Index event of non-ST or ST segment elevation ACS

Exclusion Criteria:

  • Index event is an acute complication of percutaneous coronary intervention
  • Patient has undergone Percutaneous Coronary Intervention (PCI) after the index event before the first dose of study treatment
  • Oral anticoagulation therapy that cannot be stopped
  • The conditions associated with increased risk of bradycardiac events
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan,   Korea, Republic of,   Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01294462
Other Study ID Numbers  ICMJE D5130C00027
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Judith Hsia, MD AstraZeneca
PRS Account AstraZeneca
Verification Date May 2014

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