NCT01864005CompletedPhase 4
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)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- the Percentage Inhibition of the P2Y12 Receptor
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Provision of informed consent prior to any study specific procedures
- •Female or male aged at least 18 years
- •Females of child-bearing potential must have a negative urine pregnancy test at enrolment and be willing to use reliable contraception
- •Index event of non-ST or ST segment elevation ACS.
Exclusion Criteria
- •1.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)
- •Oral anticoagulation therapy or GP IIb/IIIa receptor antagonists therapy within 30 days prior to randomisation or cannot be stopped
- •Ticagrelor or clopidogrel or other P2Y12 inhibitors within 14 days prior to randomisation
- •Requires dialysis
- •Nonselective non-steroidal anti-inflammatory drugs (NSAIDs) and prostacyclins (PGI2) therapy that cannot be stopped
Arms & Interventions
Ticagrelor
Experimental
Intervention: Ticagrelor (Drug)
clopidogrel
Active Comparator
Intervention: Clopidogrel (Drug)
Outcomes
Primary Outcomes
the Percentage Inhibition of the P2Y12 Receptor
Time Frame: at 2 hours after first dose of study drug
Note: the primary endpoint was changed per the statistical analysis plan prior database lock.
Secondary Outcomes
- the Percentage Inhibition of the P2Y12 Receptor(at 6 weeks after first dose of study drug)
Investigators
Study Sites (1)
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