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;
Crossover
Aspirin 81Mg Ec Tab twice daily for 7 days
DrugParticipants with incomplete platelet aggregation will be instructed to take EC ASA 81 mg twice daily for 7 days.
Aspirin 40Mg Chew Tab twice daily for 7 days
DrugParticipants with incomplete platelet aggregation will be instructed to take chewable ASA 40 mg twice daily for 7 days.
Aspirin 162 mg EC Tab once daily for 7 days
DrugParticipants with incomplete platelet aggregation will be instructed to take EC ASA 162 mg once daily for 7 days.
Describe the screening rate to evaluate the feasibility of a larger scale randomized controlled trial.
Determine the average number of potential participants referred to us from the Montreal Clinical Research Institute (IRCM), Centre Épic, Montreal Heart Institute and the COLCOT-T2D study who are screened per month. Hypothesis : at least 40 potential participants per month will be screened on average
Describe the enrollment rate by the proportion of referred participants who are eligible to evaluate the feasibility of a larger scale randomized controlled trial.
Hypothesis : at least 70 percent of referred patients will be eligible
Describe the enrollment rate by the proportion of eligible participants who consent to evaluate the feasibility of a larger scale randomized controlled trial.
Hypothesis : At least 40 percent of eligible patients will give their consent to participate in the run-in phase and the study
Describe the retention rate to evaluate the feasibility of a larger scale randomized controlled trial.
Determine the retention rate of randomized participants Hypothesis : at least 85 percent of all randomized subjects will complete all study visits
Adherence rate to study protocol
Hypothesis : At least 90 percent of participants will be adherent to all study doses.
Average time per participant required to complete study enrolment and all data collection.
Endpoints : Average time required to screen for, consent and enroll per participant and average time to complete study procedures and data collection per participant
Proportion of non-responders participants at day 7 of 40 mg twice daily chewable ASA regimen, 81 mg twice daily EC ASA regimen and 162 mg once daily EC ASA regimen.
Hypothesis: The 40 mg twice daily chewable ASA regimen will be associated with the lowest proportion of non-responders.
For the run-in phase, characterize the prevalence of ASA non-responders at steady state following a 7-day treatment with ASA EC 81 mg once daily in participants with type 2 diabetes.
Hypothesis: at least 10-15 percent of participants will be non-responders after taking EC ASA 81 mg die for 7 days.
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Montreal Heart Institute
Lead sponsor
Heart and Stroke Foundation of Canada
Collaborator
