Testing different aspirin doses in people with type 2 diabetes
Tests how well different aspirin doses stop platelet clumping in adults with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin in Patients With StablE Diabetes II
Key facts
- Where
- Montreal, CanadaSee the site
- Phase
- Phase 1
Where in Canada
- Montreal Heart InstituteMontreal, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Montreal Heart Institute
- Trial code
- NCT05702463
- Record updated
- 3 December 2025
- Original description
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.Read full original descriptionShow less
Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin in Patients With StablE Diabetes II
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.
Inclusion: Age ≥ 18 years; 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; 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); Willing to attend all study visits of both the run-in and randomized phases of the trial.
Exclusion: Definitive indication for ASA, including any evidence of clinical atherosclerotic disease, previous or current; Planned major surgical procedure or dental procedure during the course of the study; Chronic treatment with an oral anticoagulant, an antiplatelet agent, NSAIDs or systemic steroids; Known hypersensitivity to ASA; High-risk GI bleeding features, such as known H. pylori infection, past or present ulcer, history of bleeding from the GI tract; Bleeding diathesis; Chronic inflammatory disease requiring regular anti-inflammatory treatment; Active cancer; History of hematological malignancy or myelodysplasia; Severe hepatic insufficiency or ALT > 3 x ULN; Platelet count or hemoglobin levels outside of the normal reference range; Patient requiring dialysis; Pregnant or lactating women.