Trial | NCT01757262  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Study Participants

    0
Study in Vietnamese Patients with Coronary Heart Disease to investigate safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel
Safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel in Vietnamese Patients with Coronary Heart Disease: A Randomized, Open Label, Crossover Study
Study Started
Jan 31
2013
Primary Completion
Apr 30
2013
Anticipated
Study Completion
Apr 30
2013
Anticipated
Last Update
May 13
2013
Estimate

Drug 90 mg Ticagrelor

Morning and Evening dose for 5 days

Drug 75mg Clopidogrel

Morning dose for 5 days

Ticagrelor Experimental

90 mg Ticagrelor

Clopidogrel Active Comparator

75mg Clopidogrel

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
No Results Posted