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

Study acronym: APPEASEDII
StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv6
  2. Collaborator revisedv5
  3. Primary completion date: Jun 1, 2024 to Jun 1, 2027
    • Study completion date: Jun 8, 2024 to Jul 1, 2027
    v4
  4. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Mar 1, 2024 to Jun 1, 2024
    • Study completion date: Mar 8, 2024 to Jun 8, 2024
    • Start date changed from estimate of Apr 1, 2023 to Jun 13, 2023
    • Site details revised
  5. Start date: Feb 1, 2023 to Apr 1, 2023
    • Primary completion date: Feb 1, 2024 to Mar 1, 2024
    • Study completion date: Feb 8, 2024 to Mar 8, 2024
    • Secondary endpoints: details revised at 2 of 6 entries
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05702463
Lead Sponsor Montreal Heart Institute
Collaborators: Heart and Stroke Foundation of Canada
Conditions
(from sponsor)		 Platelet Aggregation, Type 2 Diabetes, Aspirin, Diabetes Mellitus, Type 2, Platelet Aggregation Inhibitors
Related terms Diabetes Mellitus, Diabetes Mellitus, Type 2
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov