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)
Study identifier:D5130C00027
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
Acute Coronary Syndrome
Phase
Phase 3
Healthy volunteers
No
Study drug
Ticagrelor, Clopidogrel, Acetylsalicylic acid ASA
Sex
All
Actual Enrollment
801
Study type
Interventional
Age
20 Years +
Date
Study Start Date: 01 Feb 2011
Primary Completion Date: 01 Jul 2012
Study Completion Date: 01 Jul 2012
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Oct 2015 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Ticagrelor (AZD6140) | Drug: Ticagrelor 90 mg, oral dose twice daily Other Name: AZD6140 Drug: Acetylsalicylic acid ASA Low Dose ASA |
| Active Comparator: 2 Clopidogrel | Drug: Clopidogrel 75 mg, oral dose once daily Other Name: Plavix Drug: Acetylsalicylic acid ASA Low Dose ASA |
Contacts
Investigators
Principal Investigator
Judith Hsia
AstraZeneca
