Phase 4
Completed N=60
A Phase IV Study of the Onset and Maintenance of the Antiplatelet Effect of Ticagrelor Compared With Clopidogrel in Chinese Patients With ACS
Non-ST or ST Elevation Acute Coronary Syndromes
Source: ClinicalTrials.gov NCT01864005 ↗
Enrolled (actual)
60
Serious AEs
3.3%
Results posted
Mar 2015
Primary outcomePrimary: the Percentage Inhibition of the P2Y12 Receptor — 48.20; 9.78 Percentage Inhibition — p=0.0021
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY the Percentage Inhibition of the P2Y12 Receptor |
83.78; 24.22 | <0.0001 sig |
| SECONDARY the Percentage Inhibition of the P2Y12 Receptor |
83.78; 24.22 | <0.0001 sig |
| SECONDARY the Percentage Inhibition of the P2Y12 Receptor |
83.78; 24.22 | <0.0001 sig |
| SECONDARY the Percentage Inhibition of the P2Y12 Receptor |
83.78; 24.22 | <0.0001 sig |
| SECONDARY the Percentage Inhibition of the P2Y12 Receptor |
83.78; 24.22 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- 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 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)
- 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
Data sourced from ClinicalTrials.gov (NCT01864005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.