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Genetic and Dietary Predictors of Anti-platelet Response

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04456608
Recruitment Status : Active, not recruiting
First Posted : July 2, 2020
Last Update Posted : July 2, 2020
Sponsor:
Collaborators:
Southcentral Foundation
University of Montana
Oregon Health and Science University
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Kenneth Thummel, University of Washington

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.

Condition or disease Intervention/treatment Phase
Platelet Function Drug: Aspirin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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 10-day aspirin treatment.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Program on Genetic and Dietary Predictors of Drug Response in Rural and AI/AN Populations, Project-3, SA-3, Anti-platelet Response
Actual Study Start Date : August 1, 2016
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Low and High n-3 PUFA
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
Low and high n-3 PUFA participants will receive 81-mg aspirin once a day, for 6 days.




Primary Outcome Measures :
  1. PFA-100 Platelet Aggregation Test [ Time Frame: Single 9 am blood sample on day 7 of study ]
    Citrated blood samples will be treated with collagen/epinephrine and collagen/ADP and the time to reach an aggregation endpoint will be measured.


Secondary Outcome Measures :
  1. Platelet TBX2 concentration [ Time Frame: Single 9 am blood sample on day 7 of study ]
    Platelet TBX2 concentration

  2. Platelet 20-HETE concentration [ Time Frame: Single 9 am blood sample on day 7 of study ]
    Platelet 20-HETE concentration



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04456608


Locations
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United States, Alaska
Southcentral Foundation
Anchorage, Alaska, United States, 99508
United States, Montana
University of Montana
Missoula, Montana, United States, 59812
United States, Oregon
Oregon Health & Sciences University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
University of Washington
Southcentral Foundation
University of Montana
Oregon Health and Science University
National Institute of General Medical Sciences (NIGMS)
Investigators
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Principal Investigator: Kenneth E Thummel, Ph.D. University of Washington
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Responsible Party: Kenneth Thummel, Professor: Pharmaceutics, University of Washington
ClinicalTrials.gov Identifier: NCT04456608    
Other Study ID Numbers: SITE00000212
5P01GM116691 ( U.S. NIH Grant/Contract )
First Posted: July 2, 2020    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics