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.
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