Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin in Patients With StablE Diabetes II
Eligible age
18+ yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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.
Sponsor: Montreal Heart Institute
You may qualify if…
- ✓ 1. Age ≥ 18 years;
- ✓ 2. Participant must be naïve to ASA, defined as absence of chronic treatment with ASA within the previous 3 months, and of any ASA use within the previous 2 weeks;
- ✓ 3. Type 2 diabetes, based on at least one of the following criteria: (5)
- ✓ Chronic treatment with oral antihyperglycemic agents or insulin therapy;
- ✓ Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L) (fasting is defined as no caloric intake for at least 8h);
- ✓ 2-h Plasma Glucose (2h-PG) ≥ 200 mg/dL (11.1 mmol/L) during the oral glucose tolerance test (OGTT);
- ✓ A1C ≥ 6.5% (48 mmol/ml);
- ✓ 4. Willing to attend all study visits of both the run-in and randomized phases of the trial.
You may not qualify if…
- ✕ 1. Definitive indication for ASA, including any evidence of clinical atherosclerotic disease, previous or current;
- ✕ 2. Known hypersensitivity to ASA;
- ✕ 3. Patient requiring dialysis;
- ✕ 4. Severe hepatic insufficiency or ALT \> 3 x ULN;
- ✕ 5. High-risk GI bleeding features, such as known H. pylori infection, past or present ulcer, history of bleeding from the GI tract;
- ✕ 6. Bleeding diathesis;
- ✕ 7. Platelet count or hemoglobin levels outside of the normal reference range;
- ✕ 8. Planned major surgical procedure or dental procedure during the course of the study;
Source: ClinicalTrials.gov · NCT05702463 · last updated 2025-12-03