Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients
NCT ID: NCT01706510
Last Updated: 2015-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
28 participants
INTERVENTIONAL
2012-12-31
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Ticagrelor
Ticagrelor 180 mg loading dose followed by 90 mg bid for 7 days ± 2 days
Ticagrelor
Ticagrelor 180 mg loading dose followed by 90 mg bid for 7 days ± 2 days
Clopidogrel
Clopidogrel 600 mg loading dose followed by 75 mg Daily for 7 days ± 2 days
Clopidogrel
Clopidogrel 600 mg Loading Dose followed by 75 mg Daily for 7 days ± 2 days
Ticagrelor
Ticagrelor 180 mg loading dose followed by 90 mg bid for 7 days ± 2 days
Clopidogrel
Clopidogrel 600 mg loading dose followed by 75 mg Daily for 7 days ± 2 days
Interventions
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Ticagrelor
Ticagrelor 180 mg loading dose followed by 90 mg bid for 7 days ± 2 days
Clopidogrel
Clopidogrel 600 mg loading dose followed by 75 mg Daily for 7 days ± 2 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Females must be post menopausal for at least one year or surgically sterile for at least 6 months and negative urine pregnancy test
* Self-identified as American Indian
Exclusion Criteria
* Concomitant therapy with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic index, or strong CYP3A inducers within 14 days and during study treatment and during:
* Increased bleeding risk including:
* Diabetic patients with HbAlC \> 10% at screening
* Contraindication to clopidogrel, ASA, or ticagrelor - A history of alcohol and/or substance abuse that could interfere with conduct of the trial
* Patients requiring dialysis
* Patients scheduled for revascularization (e.g., PCI, CABG) during the study period
* Any acute or chronic unstable condition in the past 30 days
* Known active or recurrent hepatic disorder
* Patients who had ACS or stent placed within 12 months of screening
* History of Uric Acid nephropathy
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Rapid City Regional Hospital, Inc
OTHER
Responsible Party
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Principal Investigators
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James S Walder, MD
Role: PRINCIPAL_INVESTIGATOR
Rapid City Regional Hospital
Locations
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Regional Heart Doctors/Black Hills Cardiovascular Research
Rapid City, South Dakota, United States
Countries
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Other Identifiers
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ISSBRIL0076
Identifier Type: -
Identifier Source: org_study_id
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