NCT05604118

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 3, 2022

Completed
Last Updated

November 3, 2022

Status Verified

October 1, 2022

Enrollment Period

2 years

First QC Date

October 20, 2022

Last Update Submit

October 27, 2022

Conditions

Keywords

plateletsphospholipidsaspirin

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Aspirin supplemented

EXPERIMENTAL
Drug: Aspirin

Off aspirin

NO INTERVENTION

Interventions

1 week of aspirin supplementation prior to sampling

Aspirin supplemented

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • \* Recent NSAID use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sir Geraint Evans Cardiovascular Research Building

Cardiff, CF144XN, United Kingdom

Location

MeSH Terms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2022

First Posted

November 3, 2022

Study Start

August 1, 2016

Primary Completion

August 1, 2018

Study Completion

June 1, 2022

Last Updated

November 3, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations