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

Study acronym: APPEASED
StatusActive, Not Recruiting
PhaseEarly Phase 1
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jul 1, 2024 to Dec 1, 2025
    • Site details revised
    v6
  2. Primary completion date: Dec 10, 2023 to Apr 1, 2024
    • Study completion date: Mar 8, 2024 to Jul 1, 2024
    v5
  3. Primary completion date: Aug 1, 2023 to Dec 10, 2023
    • Study completion date: Aug 8, 2023 to Mar 8, 2024
    v4
  4. Primary completion date: Aug 1, 2022 to Aug 1, 2023
    • Study completion date: Aug 8, 2022 to Aug 8, 2023
    v3
  5. Study title shortened, about 4 wordsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 1 study will include patients suffering from type 2 diabetes mellitus and will study their response to enteric coated aspirin at a dose of 80 mg per day for a 7-day period. The aims are to determine the feasibility of a phase 2 larger scale trial, and to characterize the prevalence of incomplete platelet inhibition after exposure to EC aspirin at doses of 80 mg once daily. Platelet function will be assessed at baseline and a day 7.
Trial Details
NCT Number NCT05105919
Lead Sponsor Montreal Heart Institute
Collaborators: Institut de Recherches Cliniques de Montreal
Conditions
(from sponsor)		 Diabetes Mellitus, Type 2
Related terms Diabetes Mellitus, Diabetes Mellitus, Type 2
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov