A Phase IV Study of the Onset and Maintenance of the Antiplatelet Effect of Ticagrelor Compared With Clopidogrel in Chinese Patients With ACS

Phase 4

Completed

• Conditions: Non-ST or ST Elevation Acute Coronary Syndromes
• Interventions: Drug: Ticagrelor; Drug: Clopidogrel

• Registration Number: NCT01864005
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-24
• Study First Submitted QC: 2013-05-24
• Study First Posted: 2013-05-29
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Results First Submitted: 2015-02-17
• Results First Submitted QC: 2015-02-17
• Results First Posted: 2015-03-02
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-28
• Last Update Posted: 2015-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ticagrelor	Ticagrelor	-
clopidogrel	Clopidogrel	-

Primary Outcome Measures

Name	Time	Method
the Percentage Inhibition of the P2Y12 Receptor	at 2 hours after first dose of study drug	Note: the primary endpoint was changed per the statistical analysis plan prior database lock.

Secondary Outcome Measures

Name	Time	Method
the Percentage Inhibition of the P2Y12 Receptor	at 6 weeks after first dose of study drug

Trial Locations

Locations (1)

Research Site; 🇨🇳 Tianjin, China