Assessing the effects of enteric-coated aspirin in patients with type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial investigates the pharmacokinetics and pharmacodynamics of enteric-coated aspirin in patients with type 2 diabetes mellitus. Participants will initially receive 80 mg of aspirin daily for 7 days, followed by randomization into three different dosing regimens to evaluate their platelet response. The study aims to identify the most effective aspirin regimen for patients who do not respond adequately to the initial dose. Platelet function will be measured at baseline and after the treatment period to assess the effectiveness of each regimen.

Why it matters

Who can join: the full rules

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;

Where it's running

• Montreal Heart Institute
  Montreal, Quebec, Canada Recruiting

Study contacts

• Principal investigator: Guillaume Marquis Gravel, MD, MSc — ICM Co. Ltd.
• Study coordinator: Guillaume Marquis Gravel, MD, MSc
• Email: guillaume.marquis.gravel@umontreal.ca
• Phone: 514-376-3330

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.