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

Recruiting now · Phase 1

Conditions studied: Platelet Aggregation, Type 2 Diabetes, Aspirin, Diabetes Mellitus, Type 2, Platelet Aggregation Inhibitors

In brief

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.

Key facts

Study ID

NCT05702463

Run by

Montreal Heart Institute

People needed

30

Starts

2023-06-13

Expected to finish

2027-07-01

Last updated by the study team

2025-12-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years;
• 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;
• Type 2 diabetes, based on at least one of the following criteria: (5)
• Chronic treatment with oral antihyperglycemic agents or insulin therapy;
• Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L) (fasting is defined as no caloric intake for at least 8h);
• 2-h Plasma Glucose (2h-PG) ≥ 200 mg/dL (11.1 mmol/L) during the oral glucose tolerance test (OGTT);
• A1C ≥ 6.5% (48 mmol/ml);
• Willing to attend all study visits of both the run-in and randomized phases of the trial.

You may not qualify if…

• Definitive indication for ASA, including any evidence of clinical atherosclerotic disease, previous or current;
• Known hypersensitivity to ASA;
• Patient requiring dialysis;
• Severe hepatic insufficiency or ALT > 3 x ULN;
• High-risk GI bleeding features, such as known H. pylori infection, past or present ulcer, history of bleeding from the GI tract;
• Bleeding diathesis;
• Platelet count or hemoglobin levels outside of the normal reference range;
• Planned major surgical procedure or dental procedure during the course of the study;
• Chronic inflammatory disease requiring regular anti-inflammatory treatment;
• Chronic treatment with an oral anticoagulant, an antiplatelet agent, NSAIDs or systemic steroids;
• Active cancer;
• History of hematological malignancy or myelodysplasia;
• Pregnant or lactating women;

Where it is running

• Montreal Heart Institute — Montreal, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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