Platelet Enzymatically Oxidized Phospholipids (eoxPL) Characterisation in a Healthy Cohort on and Off Aspirin

Sponsor
Cardiff University (Other)
Overall Status
Completed
CT.gov ID
NCT05604118
Collaborator
(none)
28
1
2
70
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Study Details

Study Description

Brief Summary

Healthy volunteers (n = 28) were recruited from the workplace (14 male, 14 female; age range 20-50 years). Ethical approval, which included informed consent, was from Cardiff University, Schools of Medicine and Dentistry Research Ethics Committee (SMREC16/02). Following a 2-week period free from non-steroidal anti-inflammatory drugs (NSAIDs), peripheral blood was obtained and platelets isolated. Participants were commenced on aspirin 75 mg once daily for seven days and then provided a repeat blood sample. Following a 2-month period, participants were invited to repeat samples pre- and post-aspirin, and again a third time 2 months later.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Platelet Enzymatically Oxidized Phospholipids (eoxPL) Characterisation in a Healthy Cohort on and Off Aspirin
Actual Study Start Date :
Aug 1, 2016
Actual Primary Completion Date :
Aug 1, 2018
Actual Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Aspirin supplemented

Drug: Aspirin
1 week of aspirin supplementation prior to sampling

No Intervention: Off aspirin

Outcome Measures

Primary Outcome Measures

  1. Platelet EoxPL differences in amounts (ng) as measured by liquid chromatography with tandem mass spectrometry [4 months]

    Samples on and off aspirin will be quantified for the 47 most common eoxPL species (as described by Slatter et al, Cell Metabolism 23, 930-944, May 10, 2016) using established liquid chromatography with tandem mass spectrometry (LC-MS/MS). Differences in amounts on and off aspirin will be quantified and tested for statistical significance.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • two-week washout period from any non-steroidal anti-inflammatory drugs (NSAIDs) use.

  • Ability to take aspirin 75 mg once daily for seven days and sampled thereafter, before stopping the aspirin.

  • Willingness to repeat this process after two months and four months of the initial sampling date.

Exclusion Criteria:
  • Recent NSAID use

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sir Geraint Evans Cardiovascular Research Building Cardiff United Kingdom CF144XN

Sponsors and Collaborators

  • Cardiff University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cardiff University
ClinicalTrials.gov Identifier:
NCT05604118
Other Study ID Numbers:
  • SMREC16/02
First Posted:
Nov 3, 2022
Last Update Posted:
Nov 3, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Cardiff University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 3, 2022