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)
Status and phase
Completed
Phase 3
Conditions
Percutaneous Coronary Intervention
Acute Coronary Syndrome
Treatments
Drug: Clopidogrel
Drug: Ticagrelor
Drug: Acetylsalicylic acid ASA
Details and patient eligibility
About
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).
Enrollment
801 patients
Sex
All
Ages
20+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
801 participants in 2 patient groups
1
Experimental group
Description:
Ticagrelor (AZD6140)
Treatment:
Drug: Ticagrelor
Drug: Acetylsalicylic acid ASA
2
Active Comparator group
Description:
Clopidogrel
Treatment:
Drug: Acetylsalicylic acid ASA
Drug: Clopidogrel
Trial contacts and locations
94
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Data sourced from clinicaltrials.gov
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