Status:
COMPLETED
A Phase IV Study of the Onset and Maintenance of the Antiplatelet Effect of Ticagrelor Compared With Clopidogrel in Chinese Patients With ACS
Lead Sponsor:
AstraZeneca
Conditions:
Non-ST or ST Elevation Acute Coronary Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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.
Eligibility Criteria
Inclusion
- 1\. Provision of informed consent prior to any study specific procedures
- 2\. Female or male aged at least 18 years
- 3\. Females of child-bearing potential must have a negative urine pregnancy test at enrolment and be willing to use reliable contraception
- 4\. Index event of non-ST or ST segment elevation ACS.
Exclusion
- Contraindication or other reason that clopidogrel or ticagrelor should not be administered (eg, hypersensitivity, active bleeding, moderate or severe liver disease, history of previous intracranial bleed, GI bleed within the past 6 months, major surgery within 30 days)
- 2\. Oral anticoagulation therapy or GP IIb/IIIa receptor antagonists therapy within 30 days prior to randomisation or cannot be stopped
- 3\. Ticagrelor or clopidogrel or other P2Y12 inhibitors within 14 days prior to randomisation
- 4\. Requires dialysis
- 5\. Nonselective non-steroidal anti-inflammatory drugs (NSAIDs) and prostacyclins (PGI2) therapy that cannot be stopped
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01864005
Start Date
May 1 2013
End Date
March 1 2014
Last Update
May 15 2015
Active Locations (3)
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1
Research Site
Beijing, China
2
Research Site
Shenyang, China
3
Research Site
Tianjin, China