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

RecruitingPhase 1Ages 18 Years - anyAllMontreal Heart Institute
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 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. Exclusion Criteria: 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; 9. Chronic inflammatory disease requiring regular anti-inflammatory treatment; 10. Chronic treatment with an oral anticoagulant, an antiplatelet agent, NSAIDs or systemic steroids; 11. Active cancer; 12. History of hematological malignancy or myelodysplasia; 13. Pregnant or lactating women;
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What it tests

  • Aspirin 81Mg Ec Tab twice daily for 7 days
  • Aspirin 40Mg Chew Tab twice daily for 7 days
  • Aspirin 162 mg EC Tab once daily for 7 days
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Where

1 site
Montreal Heart Institute
Montreal, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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