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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01294462
First received: February 10, 2011
Last updated: June 18, 2014
Last verified: May 2014

February 10, 2011
June 18, 2014
February 2011
July 2012   (final data collection date for primary outcome measure)
  • Major Bleeding [ Time Frame: Ongoing up to12 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01294462 on ClinicalTrials.gov Archive Site
  • Major and Minor Bleeding [ Time Frame: Ongoing up to12 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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)
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

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Acute Coronary Syndrome
  • Percutaneous Coronary Intervention
  • 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
  • Experimental: 1
    Ticagrelor (AZD6140)
    Interventions:
    • Drug: Ticagrelor
    • Drug: Acetylsalicylic acid ASA
  • Active Comparator: 2
    Clopidogrel
    Interventions:
    • Drug: Clopidogrel
    • Drug: Acetylsalicylic acid ASA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
801
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan,   Korea, Republic of,   Taiwan
 
NCT01294462
D5130C00027
No
AstraZeneca
AstraZeneca
Not Provided
Study Director: Judith Hsia, MD AstraZeneca
AstraZeneca
May 2014

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