TO MEASURE THE EFFECT OF ASPIRIN 300MGS ON PLATELETS IN HEALTHY CONTROLS

Phase 1

• Conditions: Cardiovascular disease; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-000499-89-IE
• Lead Sponsor: Royal College Of Surgeons Ireland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-22
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

Inclusion criteria
–Volunteers male or female over the age of 18yrs
–Willing and able to give informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

Exclusion Criteria

–Unwilling or unable to give informed consent
–History of allergies to NSAID or Aspirin
–Contraindications to taking aspirin such as peptic ulcer disease, bleeding disorder, haemorrhagic stroke, asthma
–Known haematological/platelet disorder
–Subject currently taking medication known to affect platelet response including aspirin or P2Y12 inhibitors or has taken them in the last 21 days.
–Subject is currently taking analgesics including NSAIDs, cold or sinus remedies or H2 blockers or proton pump inhibitors
–Subject is pregnant or breast feeding.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To measure the platelet function post aspirin 300mgs.;Secondary Objective: Not appicable;Timepoint(s) of evaluation of this end point: 4-6 hours post administration.;<br> Primary end point(s): •The effect size of LTA platelet aggregation and the dynamic platelet function assay(DPFA) after administration of Aspirin 300mgs.<br> •The variation in platelet response pre and post Aspirin 300mgs using standard LTA and the dynamic assay. <br> •Reliability for measurement of arachidonic acid-induced platelet activity in healthy vounteers and donors on aspirin therapy. <br> <br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): No;Timepoint(s) of evaluation of this end point: 4-6hrs post administration of aspirin