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
Overview
- Phase
- Phase 3
- Intervention
- Acetylsalicylic acid ASA
- Conditions
- Acute Coronary Syndrome
- Sponsor
- AstraZeneca
- Enrollment
- 801
- Locations
- 1
- Primary Endpoint
- Major Bleeding
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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).
Investigators
Eligibility Criteria
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
Arms & Interventions
2
Clopidogrel
Intervention: Acetylsalicylic acid ASA
1
Ticagrelor (AZD6140)
Intervention: Ticagrelor
1
Ticagrelor (AZD6140)
Intervention: Acetylsalicylic acid ASA
2
Clopidogrel
Intervention: Clopidogrel
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Major and Minor Bleeding(Ongoing up to12 months)
- Composite of All-cause Mortality, MI or Stroke(Ongoing up to 12 months)