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

AstraZeneca

Status and phase

Withdrawn

Phase 3

Conditions

Coronary Heart Disease

Treatments

Drug: 75mg Clopidogrel

Drug: 90 mg Ticagrelor

Study type

Interventional

Funder types

Industry

Identifiers

NCT01757262

D5130C00078

Details and patient eligibility

About

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

Full description

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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