NCT05702463RecruitingPhase 1
Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin in Patients With StablE Diabetes II
Source: ClinicalTrials.gov · Last updated 3 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 5 Jan 2023
- Start date
- 13 Jun 2023
- Primary completion date
- 1 Jun 2027
- Lead sponsor
- Montreal Heart Institute
- Diseases
- Type 2 diabetes
- NCT number
- NCT05702463
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 30
- From 13 Jun 2023 to the primary completion date, 1 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Definitive indication for ASA, including any evidence of clinical atherosclerotic disease, previous or current;
- Planned major surgical procedure or dental procedure during the course of the study;
- Chronic treatment with an oral anticoagulant, an antiplatelet agent, NSAIDs or systemic steroids;
Other illness
- Known hypersensitivity to ASA;
- High-risk GI bleeding features, such as known H. pylori infection, past or present ulcer, history of bleeding from the GI tract;
- Bleeding diathesis;
- Chronic inflammatory disease requiring regular anti-inflammatory treatment;
- Active cancer;
- History of hematological malignancy or myelodysplasia;
Lab values
- Severe hepatic insufficiency or ALT \> 3 x ULN;
- Platelet count or hemoglobin levels outside of the normal reference range;
Other
- Patient requiring dialysis;
- Pregnant or lactating women;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Montreal Heart Institute Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.