NCT05702463 Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin in Patients With StablE Diabetes II
| NCT ID | NCT05702463 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Montreal Heart Institute |
| Condition | Platelet Aggregation |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-06-13 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2023-06-13 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 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); 4. Willing to attend all study visits of both the run-in and randomized phases of the trial. Exclusion Criteria: 1. Definitive indication for ASA, including any evidence of clinical atherosclerotic disease, previous or current; 2. Known hypersensitivity to ASA; 3. Patient requiring dialysis; 4. Severe hepatic insufficiency or ALT \> 3 x ULN; 5. High-risk GI bleeding features, such as known H. pylori infection, past or present ulcer, history of bleeding from the GI tract; 6. Bleeding diathesis; 7. Platelet count or hemoglobin levels outside of the normal reference range; 8. Planned major surgical procedure or dental procedure during the course of the study; 9. Chronic inflammatory disease requiring regular anti-inflammatory treatment; 10. Chronic treatment with an oral anticoagulant, an antiplatelet agent, NSAIDs or systemic steroids; 11. Active cancer; 12. History of hematological malignancy or myelodysplasia; 13. Pregnant or lactating women;
Contact & Investigator
Guillaume Marquis Gravel, MD, MSc
PRINCIPAL INVESTIGATOR
ICM Co. Ltd.
Frequently Asked Questions
Who can join the NCT05702463 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Platelet Aggregation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05702463 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05702463 currently recruiting?
Yes, NCT05702463 is actively recruiting participants. Contact the research team at guillaume.marquis.gravel@umontreal.ca for enrollment information.
Where is the NCT05702463 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT05702463 clinical trial?
NCT05702463 is sponsored by Montreal Heart Institute. The principal investigator is Guillaume Marquis Gravel, MD, MSc at ICM Co. Ltd.. The trial plans to enroll 30 participants.