RecruitingPhase 1NCT05702463

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


Sponsor

Montreal Heart Institute

Enrollment

30 participants

Start Date

Jun 13, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how a daily low-dose aspirin (enteric-coated) works in people with type 2 diabetes — specifically looking at how the body processes the aspirin and whether it affects blood clotting. The goal is to understand if aspirin dosing strategies need to be adjusted for people with diabetes. **You may be eligible if...** - You are 18 years or older - You have type 2 diabetes (diagnosed by blood sugar tests or treatment with diabetes medications) - You have not taken aspirin regularly in the past 3 months - You are willing to attend all required study visits **You may NOT be eligible if...** - You have a history of heart attack, stroke, or other cardiovascular disease that already requires aspirin - You are allergic to aspirin - You need dialysis or have severe liver problems - You have a stomach ulcer, history of GI bleeding, or H. pylori infection - You take blood thinners, anti-inflammatory drugs (NSAIDs), or steroids regularly - You have active cancer - You are planning major surgery or dental work during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAspirin 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.

DRUGAspirin 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.

DRUGAspirin 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

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NCT05702463


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