Coronary Heart Disease
Conditions
Keywords
Coronary Heart Disease
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
Interventions
DRUG90 mg Ticagrelor
Morning and Evening dose for 5 days
DRUG75mg Clopidogrel
Morning dose for 5 days
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Safety profile in terms of adverse events, blood pressure, pulse, ECG (Electrocardiogram), physical examination, and safety laboratory variables | From screening to followup (8 weeks) |
Outcome results
None listed