Back to resultsA Clinical Study of Safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel in Vietnamese Patient
Primary Purpose
Coronary Heart Disease
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
90 mg Ticagrelor
75mg Clopidogrel
Sponsored by
About this trial
This is an interventional basic science trial for Coronary Heart Disease focused on measuring Coronary Heart Disease
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ticagrelor
Clopidogrel
Arm Description
90 mg Ticagrelor
75mg Clopidogrel
Outcomes
Primary Outcome Measures
Pharmacodynamics of Ticagrelor on P2Y12 receptor blockade measured by the VerifyNow P2Y12 assay[expressed as P2Y12 reaction units (PRU)]
Pharmacodynamics of Clopidogrel P2Y12 receptor blockade measured by the VerifyNow P2Y12 assay[expressed as P2Y12 reaction units (PRU)]
Secondary Outcome Measures
Safety profile in terms of adverse events, blood pressure, pulse, ECG (Electrocardiogram), physical examination, and safety laboratory variables
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01757262
Brief Title
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
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Withdrawn
Study Start Date
January 2013 (undefined)
Primary Completion Date
April 2013 (Anticipated)
Study Completion Date
April 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
Coronary Heart Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ticagrelor
Arm Type
Experimental
Arm Description
90 mg Ticagrelor
Arm Title
Clopidogrel
Arm Type
Active Comparator
Arm Description
75mg Clopidogrel
Intervention Type
Drug
Intervention Name(s)
90 mg Ticagrelor
Intervention Description
Morning and Evening dose for 5 days
Intervention Type
Drug
Intervention Name(s)
75mg Clopidogrel
Intervention Description
Morning dose for 5 days
Primary Outcome Measure Information:
Title
Pharmacodynamics of Ticagrelor on P2Y12 receptor blockade measured by the VerifyNow P2Y12 assay[expressed as P2Y12 reaction units (PRU)]
Time Frame
Day 1 pre-dose and at 0 (pre-dose), 1, 2, 8, 12 and 24 hours post morning dose on Day 5
Title
Pharmacodynamics of Clopidogrel P2Y12 receptor blockade measured by the VerifyNow P2Y12 assay[expressed as P2Y12 reaction units (PRU)]
Time Frame
Day 1 pre-dose and at 0 (pre-dose), 1, 2, 8, 12 and 24 hours post morning dose on Day 5
Secondary Outcome Measure Information:
Title
Safety profile in terms of adverse events, blood pressure, pulse, ECG (Electrocardiogram), physical examination, and safety laboratory variables
Time Frame
From screening to followup (8 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nguyen Lan Viet, MD
Organizational Affiliation
National Heart Institute, Bach Mai Hospital, Vietnam
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Judith Hsia, MD
Organizational Affiliation
Astrazeneca, Wilmington, US
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Miriana Kujacic, MD
Organizational Affiliation
Astrazeneca, Molndal, Sweden
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study of Safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel in Vietnamese Patient
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