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: August 17, 2012
Last verified: August 2012

February 10, 2011
August 17, 2012
February 2011
July 2012   (final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
  • 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
  • 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 ]
  • 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 ]
  • Effect of Ticagrelor (AZD6140) compared to Clopidogrel by assessing number of Adverse events (AEs) [ Time Frame: Ongoing up to 12 months ] [ Designated as safety issue: Yes ]
  • Effect of Ticagrelor (AZD6140) compared to Clopidogrel by assessing number of laboratory values [ Time Frame: Ongoing up to 12 months ] [ Designated as safety issue: Yes ]
  • Effect of Ticagrelor (AZD6140) compared to Clopidogrel by assessing number of physical examination [ Time Frame: Ongoing up to 12 months ] [ Designated as safety issue: Yes ]
  • Effect of Ticagrelor (AZD6140) compared to Clopidogrel by assessing number of electrocardiography (12-lead ECG) [ Time Frame: Ongoing up to 12 months ] [ Designated as safety issue: Yes ]
  • Effect of Ticagrelor (AZD6140) compared to Clopidogrel by assessing number of Holter ECG [ Time Frame: Ongoing up to 12 months ] [ Designated as safety issue: Yes ]
  • Effect of Ticagrelor (AZD6140) compared to Clopidogrel by assessing number of vital signs (heart rate and blood pressure (systolic and diastolic)). [ Time Frame: Ongoing up to 12 months ] [ Designated as safety issue: Yes ]
  • 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
800
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
August 2012

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