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

Recruiting Phase 1 Interventional Study
Platelet Aggregation Type 2 Diabetes Aspirin Diabetes Mellitus, Type 2 Platelet Aggregation Inhibitors
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Prevention
Participants needed
30 (estimated)
Sponsor
Montreal Heart Institute · Other
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About This Trial
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 8…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years; 2. 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; 3. Type 2 diabetes, based on at least one of the following criteria: (5) * Chronic treatment…
Contacts

Guillaume Marquis Gravel, MD, MSc

514-376-3330

guillaume.marquis.gravel@umontreal.ca

CONTACT

Marie Lordkipanidzé B. Pharm, Ph.D.

514-376-3330

marie.lordkipanidze@umontreal.ca

CONTACT