Clinical trial NCT01757262: A Clinical Study of Safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel in Vietnamese Patient
Official title: Safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel in Vietnamese Patients With Coronary Heart Disease: A Randomized, Open Label, Crossover Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Coronary Heart Disease
Keywords: Coronary Heart Disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-12-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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

Eligibility 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

Primary outcomes:
measure: Pharmacodynamics of Ticagrelor on P2Y12 receptor blockade measured by the VerifyNow P2Y12 assay[expressed as P2Y12 reaction units (PRU)]
timeFrame: Day 1 pre-dose and at 0 (pre-dose), 1, 2, 8, 12 and 24 hours post morning dose on Day 5
measure: Pharmacodynamics of Clopidogrel P2Y12 receptor blockade measured by the VerifyNow P2Y12 assay[expressed as P2Y12 reaction units (PRU)]
timeFrame: Day 1 pre-dose and at 0 (pre-dose), 1, 2, 8, 12 and 24 hours post morning dose on Day 5
Secondary outcomes:
measure: Safety profile in terms of adverse events, blood pressure, pulse, ECG (Electrocardiogram), physical examination, and safety laboratory variables
timeFrame: From screening to followup (8 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: National Heart Institute, Bach Mai Hospital, Vietnam
name: Nguyen Lan Viet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Astrazeneca, Wilmington, US
name: Judith Hsia, MD
role: STUDY_DIRECTOR
affiliation: Astrazeneca, Molndal, Sweden
name: Miriana Kujacic, MD
role: STUDY_CHAIR
References: