A Clinical Study of Safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel in Vietnamese Patient
This study has been withdrawn prior to enrollment.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01757262
First received: December 21, 2012
Last updated: May 10, 2013
Last verified: May 2013
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Purpose
Study in Vietnamese Patients with Coronary Heart Disease to investigate safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Heart Disease |
Drug: 90 mg Ticagrelor Drug: 75mg Clopidogrel |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| 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 |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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) ] [ Designated as safety issue: Yes ]
| Enrollment: | 0 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ticagrelor
90 mg Ticagrelor
|
Drug: 90 mg Ticagrelor
Morning and Evening dose for 5 days
|
|
Active Comparator: Clopidogrel
75mg Clopidogrel
|
Drug: 75mg Clopidogrel
Morning dose for 5 days
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01757262
Please refer to this study by its ClinicalTrials.gov identifier: NCT01757262
Sponsors and Collaborators
AstraZeneca
Investigators
| Principal Investigator: | Nguyen Lan Viet, MD | National Heart Institute, Bach Mai Hospital, Vietnam | |
| Study Director: | Judith Hsia, MD | Astrazeneca, Wilmington, US | |
| Study Chair: | Miriana Kujacic, MD | Astrazeneca, Molndal, Sweden |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01757262 History of Changes |
| Other Study ID Numbers: | D5130C00078 |
| Study First Received: | December 21, 2012 |
| Last Updated: | May 10, 2013 |
| Health Authority: | Vietnam: Ministry of Health - Vietnam |
Keywords provided by AstraZeneca:
|
Coronary Heart Disease |
Additional relevant MeSH terms:
|
Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases Clopidogrel Ticagrelor Hematologic Agents |
Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Pharmacologic Actions Physiological Effects of Drugs Platelet Aggregation Inhibitors Purinergic Agents Purinergic Antagonists Purinergic P2 Receptor Antagonists Purinergic P2Y Receptor Antagonists Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015