A Phase IV Study of the Onset and Maintenance of the Antiplatelet Effect of Ticagrelor Compared with Clopidogrel in Chinese Patients with ACS - HouYi
Study identifier:D5130L00053
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Multicentre, Open-label, Randomized, 6-week, Phase IV Study of the Onset and Maintenance of the Antiplatelet Effect of Ticagrelor Compared with Clopidogrel with Aspirin as Background Therapy in Chinese Patients with Non-ST or ST Elevation Acute Coronary Syndromes (ACS)
Medical condition
Non-ST or ST Elevation Acute Coronary Syndromes
Phase
Phase 4
Healthy volunteers
No
Study drug
Ticagrelor, Clopidogrel
Sex
All
Actual Enrollment
60
Study type
Interventional
Age
18 Years - 150 Years
Date
Study Start Date: 01 May 2013
Primary Completion Date: 01 Mar 2014
Study Completion Date: 01 Mar 2014
Study design
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Feb 2015 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Ticagrelor | Drug: Ticagrelor 90mg tablets. loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. Duration of treatment: 6 weeks. |
| Active Comparator: clopidogrel | Drug: Clopidogrel 75mg capsule. loading dose of 600mg clopidogrel capsules (eight 75mg capsules) taken orally, follow by 75mg of clopidogrel capsules orally od. Duration of treatment: 6 weeks. |
Contacts
Investigators
Principal Investigator
Yundai Chen
The General Hospital of People’s Liberation Army
