A Clinical Study of Safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel in Vietnamese Patient

Phase 3

Withdrawn

• Conditions: Coronary Heart Disease
• Interventions: Drug: 90 mg Ticagrelor; Drug: 75mg Clopidogrel

• Registration Number: NCT01757262
• Lead Sponsor: AstraZeneca

Brief Summary

Study in Vietnamese Patients with Coronary Heart Disease to investigate safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel

Detailed Description

Safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel in Vietnamese Patients with Coronary Heart Disease: A Randomized, Open Label, Crossover Study

Study Timeline

• Study First Submitted: 2012-12-21
• Study First Submitted QC: 2012-12-21
• Study First Posted: 2012-12-28
• Study Start: 2013-01
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-10
• Last Update Posted: 2013-05-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Male or female Vietnamese patients (as confirmed by the Principal Investigator) aged >18 years with suitable veins for cannulations or repeated venipunctures and stable coronary heart disease
• Stable use of aspirin 75 to 100 mg daily for at least the preceding 2 weeks and which will be continued throughout the study period
• Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive
• Women must have a negative urine pregnancy test at Visit 1

Exclusion Criteria

• History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study
• Unstable angina or any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IP
• Patients who had acute coronary syndrome or stent placed within 12 months of screening
• Planned arterial revascularization
• Current use of ADP receptor blockers (eg, clopidogrel, ticlopidine, prasugrel), dipyridamole or cilostazol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ticagrelor	90 mg Ticagrelor	90 mg Ticagrelor
Clopidogrel	75mg Clopidogrel	75mg Clopidogrel

Primary Outcome Measures

Name	Time	Method
Pharmacodynamics of Ticagrelor on P2Y12 receptor blockade measured by the VerifyNow P2Y12 assay[expressed as P2Y12 reaction units (PRU)]	Day 1 pre-dose and at 0 (pre-dose), 1, 2, 8, 12 and 24 hours post morning dose on Day 5
Pharmacodynamics of Clopidogrel P2Y12 receptor blockade measured by the VerifyNow P2Y12 assay[expressed as P2Y12 reaction units (PRU)]	Day 1 pre-dose and at 0 (pre-dose), 1, 2, 8, 12 and 24 hours post morning dose on Day 5

Secondary Outcome Measures

Name	Time	Method
Safety profile in terms of adverse events, blood pressure, pulse, ECG (Electrocardiogram), physical examination, and safety laboratory variables	From screening to followup (8 weeks)