A Phase IV Study of the Onset and Maintenance of the Antiplatelet Effect of Ticagrelor Compared With Clopidogrel in Chinese Patients With ACS (HouYi)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: May 24, 2013
Last updated: February 26, 2014
Last verified: February 2014
The purpose of this study is to test the hypothesis that the onset of the antiplatelet effect of ticagrelor is more rapid and greater than clopidogrel in Chinese patients with ACS.
Non-ST or ST Elevation Acute Coronary Syndromes
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)|
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- P2Y12 reaction units (PRU) measured by Verify NowTM P2Y12 assay [ Time Frame: at 2 hours after first dose of study drug ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- P2Y12 reaction units (PRU) measured by Verify NowTM P2Y12 assay [ Time Frame: at 0.5, 8 and 24 hours and 6 weeks after first dose of study drug ] [ Designated as safety issue: No ]
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
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||
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 and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01864005
Sponsors and Collaborators
|Principal Investigator:||Yundai Chen, Professor||The General Hospital of People's Liberation Army|