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

• Status: Withdrawn
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Clopidogrel; Ticagrelor; Ticlopidine

Criteria

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