Actively Recruiting
Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin in Patients With StablE Diabetes II
Led by Montreal Heart Institute · Updated on 2025-12-03
30
Participants Needed
1
Research Sites
211 weeks
Total Duration
On this page
Sponsors
M
Montreal Heart Institute
Lead Sponsor
H
Heart and Stroke Foundation of Canada
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin in Patients With StablE Diabetes II
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- No chronic aspirin treatment within the last 3 months and no aspirin use within the past 2 weeks
- Diagnosis of type 2 diabetes defined by treatment with oral antihyperglycemic agents or insulin, fasting plasma glucose ≥ 126 mg/dL, 2-hour plasma glucose ≥ 200 mg/dL during OGTT, or A1C ≥ 6.5%
- Willingness to attend all study visits for both run-in and randomized phases
You will not qualify if you...
- Any clear indication for aspirin use due to clinical atherosclerotic disease
- Known allergy or hypersensitivity to aspirin
- Need for dialysis
- Severe liver failure or ALT greater than 3 times the upper normal limit
- High risk of gastrointestinal bleeding such as H. pylori infection, past or present ulcers, or prior GI bleeding
- Bleeding disorders
- Platelet count or hemoglobin outside normal ranges
- Planned major surgery or dental procedure during the study
- Chronic inflammatory disease requiring regular anti-inflammatory treatment
- Chronic use of oral anticoagulants, antiplatelet agents, NSAIDs, or systemic steroids
- Active cancer
- History of blood cancers or myelodysplasia
- Pregnancy or breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Actively Recruiting
Research Team
G
Guillaume Marquis Gravel, MD, MSc
CONTACT
M
Marie Lordkipanidzé B. Pharm, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
3
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