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.
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;
Definitive indication for ASA, including any evidence of clinical atherosclerotic disease, previous or current;
Known hypersensitivity to ASA;
Patient requiring dialysis;
Severe hepatic insufficiency or ALT > 3 x ULN;
Montreal Heart Institute
Lead sponsor
Heart and Stroke Foundation of Canada
Collaborator