Program on Genetic and Dietary Predictors of Drug Response in Rural and AI/AN Populations, Project-3, SA-3, Anti-platelet Response

SITE00000212

This study will investigate differences in platelet aggregation under basal and aspirin-treated conditions in American Indian and Alaska Native people who have extreme levels (low and high) of n-3 polyunsaturated fatty acids (n-3 PUFAs, EPA and DHA) in red blood cell membranes. The study will also determine whether or not platelet aggregation under the different conditions is modified by CYP4A11, CYP4F2, CYP4F11, PEAR1, and ACTN1 gene variation.

2016-08-01

2023-07-31

2023-07-31

Terminated

Early phase I

126

Inclusion Criteria: 1. Participants with no history of significant medical conditions including cardiac, pulmonary, hepatic, gastrointestinal, or renal disease, or HIV. 2. Participants will be males or females, 18 years or older. 3. Participants will be self-identified as: Yup'ik or Cup'ik (YK-Delta), AI/AN (SCF), or a member of the Confederated Salish and Kootenai Tribe (Flathead Reservation). 4. Participants must read and understand English or Yup'ik. 5. Participants must be able to provide informed consent. Exclusion Criteria: 1. Participants with any significant chronic medical condition, including cardiac, pulmonary, hepatic, gastrointestinal, or renal disease, or HIV. 2. Participants less than 18 yrs of age. 3. Participants unable to read and understand English or Yup'ik. 4. Participants unable to provide informed consent. 5. Recent (within 2 weeks) use of aspirin, NSAIDs, antihistamines, or any prescription anticoagulant drug such as warfarin.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'In this study we will recruit individuals who have previously been determined to have low or high RBC n-3 PUFA content and test platelet function at baseline and after 2-day aspirin treatment.', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 126, 'type': 'ACTUAL'}}

2023-12-15