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OpenTrials
Completed

NCT Number: NCT04280549

Platelet PAR-1 Activation in Health and Diabetes

Platelet activation has been associated with bad events like heart attack and stroke. There are a variety of platelet activators that regulate how active a platelet is. We are interested in Protease-activated receptors (PAR)-1. We are currently studying PAR-1 activation in persons with severe peripheral artery disease. We seek, through this project, to understand PAR-1 activation in persons without peripheral artery disease. As many patients with peripheral artery disease have diabetes, we will also evaluate PAR-1 activation in persons with type 2 diabetes. In addition we will assess the impact of the glucagon-like peptide (GLP)-1 signaling pathway on platelet activation. Levels of platelet activation will be determined using platelet aggregation experiments and assessment of platelet-monocyte aggregates in peripheral blood.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy men and women ≥60 years of age OR
  • Type 2 diabetic men and women ≥60 years of age

Exclusion criteria

  • Active cancer
  • Prior myocardial infarction, prior stroke, diagnosed peripheral artery disease
  • Severe liver (cirrhosis, cancer, or end-stage liver disease), kidney disease (eGFR <30 cc/min).
  • Pregnancy or lactation
  • Active vasculitis
  • Anticipated lifespan < 2 years
  • Current use of a DOAC

Treatment and study plan

Primary outcomes

  1. Platelet Activation

    Time frame: One day

    Number of dilysyl-MDA cross-links formed in human platelets

  2. Protease Activated Receptor-1 Activation

    Time frame: One day

    Number of cleaved PAR-1 receptors in proportion to number of uncleared PAR-1 receptors

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 21, 2020
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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