Platelet Dysfunction Due to Aspirin Clinical Trial
Official title:
Platelet Enzymatically Oxidized Phospholipids (eoxPL) Characterisation in a Healthy Cohort on and Off Aspirin
NCT number | NCT05604118 |
Other study ID # | SMREC16/02 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 1, 2016 |
Est. completion date | June 1, 2022 |
Verified date | October 2022 |
Source | Cardiff University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | June 1, 2022 |
Est. primary completion date | August 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 50 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Sir Geraint Evans Cardiovascular Research Building | Cardiff |
Lead Sponsor | Collaborator |
---|---|
Cardiff University |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Platelet EoxPL differences in amounts (ng) as measured by liquid chromatography with tandem mass spectrometry | 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. | 4 months |
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