Clinical Research Directory
Browse clinical research sites, groups, and studies.
Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin in Patients With StablE Diabetes II
Sponsor: Montreal Heart Institute
Summary
This phase 2 study will include patients suffering from type 2 diabetes mellitus and will first study their response to enteric coated aspirin at a dose of 80 mg per day for a 7-day period. Participants with an incomplete platelet inhibition after exposure to EC aspirin at doses of 80 mg once daily will be randomized to a random order of 3 different ASA regimens: EC ASA 162 mg once daily, EC ASA 81 mg twice daily and chewable ASA 40 mg twice daily. The aims are to determine the feasibility of a larger scale trial, and to determine the regimen associated with the lowest proportion of non-responders after randomization. Platelet function will be assessed at baseline and at day 7 of each arms of the study.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2023-06-13
Completion Date
2027-07-01
Last Updated
2025-12-03
Healthy Volunteers
No
Conditions
Interventions
Aspirin 81Mg Ec Tab twice daily for 7 days
Participants with incomplete platelet aggregation will be instructed to take EC ASA 81 mg twice daily for 7 days.
Aspirin 40Mg Chew Tab twice daily for 7 days
Participants with incomplete platelet aggregation will be instructed to take chewable ASA 40 mg twice daily for 7 days.
Aspirin 162 mg EC Tab once daily for 7 days
Participants with incomplete platelet aggregation will be instructed to take EC ASA 162 mg once daily for 7 days.
Locations (1)
Montreal Heart Institute
Montreal, Quebec, Canada