Genetic and Dietary Predictors of Anti-platelet Response

NCT04456608 | Terminated Phase 4 FDA Drug

• 2 other identifiers: SITE000002125P01GM116691
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Platelet Function

Outcome Measures

Primary Outcomes (1)

• PFA-100 Platelet Aggregation Test

  Citrated blood samples will be treated with collagen/epinephrine and collagen/ADP and the time to reach an aggregation endpoint will be measured.

  Single 9 am blood sample on day 3 of study

Secondary Outcomes (2)

• Platelet TBX2 concentration

  Single 9 am blood sample on day 3 of study

• Platelet 20-HETE concentration

  Single 9 am blood sample on day 3 of study

Study Arms (1)

Low and High n-3 PUFA

EXPERIMENTAL

Individuals with low or high n-3 PUFA RBC concentration will be given aspirin (81 mg of aspirin once a day, for 6 days)

Drug: Aspirin

Interventions

Aspirin DRUG

Low and high n-3 PUFA participants will receive 81-mg aspirin once a day, for 6 days.

Low and High n-3 PUFA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with no history of significant medical conditions including cardiac, pulmonary, hepatic, gastrointestinal, or renal disease, or HIV.
• Participants will be males or females, 18 years or older.
• 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).
• Participants must read and understand English or Yup'ik.
• Participants must be able to provide informed consent.

You may not qualify if:

• Participants with any significant chronic medical condition, including cardiac, pulmonary, hepatic, gastrointestinal, or renal disease, or HIV.
• Participants less than 18 yrs of age.
• Participants unable to read and understand English or Yup'ik.
• Participants unable to provide informed consent.
• Recent (within 2 weeks) use of aspirin, NSAIDs, antihistamines, or any prescription anticoagulant drug such as warfarin.

Sponsors & Collaborators

• University of Washington: lead
• Southcentral Foundation: collaborator
• University of Montana: collaborator
• Oregon Health and Science University: collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (3)

Southcentral Foundation

Anchorage, Alaska, 99508, United States

Location

University of Montana

Missoula, Montana, 59812, United States

Location

Oregon Health & Sciences University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Kenneth E Thummel, Ph.D.

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor: Pharmaceutics

Model Details: 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.

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 2, 2020
• Study Start: August 1, 2016
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: December 15, 2023

Record last verified: 2023-12

Locations

US (3)