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Clinical Trial Details

Trial ID: L3423
Source ID: NCT05702463
Associated Drug: Aspirin 81mg Ec Tab Twice Daily For 7 Days
Title: Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin in Patients With StablE Diabetes II
Acronym: APPEASEDII
Status: RECRUITING
Study Results: NO
Results:
Conditions: Platelet Aggregation|Type 2 Diabetes|Aspirin|Diabetes Mellitus, Type 2|Platelet Aggregation Inhibitors
Interventions: DRUG: Aspirin 81Mg Ec Tab twice daily for 7 days|DRUG: Aspirin 40Mg Chew Tab twice daily for 7 days|DRUG: Aspirin 162 mg EC Tab once daily for 7 days
Outcome Measures: Primary: 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, 1 year|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, 1 year|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, 1 year|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, 1 year|Among initial ASA non-responder participants, define the proportion of participants that remain ASA non-responders with different formulations and dosing regimens of ASA., Hypothesis : in at least one of the regimens studied, the proportion of ASA non-responders will be less than 50 percent., 1 year | Secondary: Adherence rate to study protocol, Hypothesis : At least 90 percent of participants will be adherent to all study doses., 1 year|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, 1 year|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., 1 year|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., 1 year|Proportion of participants who are non-responders to ASA with each dose as measured by serum levels of thromboxane B2 (TxB2)., Non-resposne to ASA as measured by serum levels of thromboxane B2 (TxB2)., 1 year|Platelet response levels to various agonists not directly related to the pharmacological target of ASA, including ADP, collagen, epinephrine and thrombin receptor-activating peptide (TRAP)., Non-response to ASA as measured with ADP, collagen, epinephrine and thrombin receptor-activating peptide (TRAP)., 1 year
Sponsor/Collaborators: Sponsor: Montreal Heart Institute | Collaborators: Heart and Stroke Foundation of Canada
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2023-06-13
Completion Date: 2027-07-01
Results First Posted:
Last Update Posted: 2024-09-19
Locations: Montreal Heart Institute, Montréal, Quebec, H1T 1C8, Canada
URL: https://clinicaltrials.gov/show/NCT05702463