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RECRUITING
NCT05702463
PHASE1

Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin in Patients With StablE Diabetes II

Sponsor: Montreal Heart Institute

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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.

DRUG

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