💬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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 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;
💊
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
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.