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

Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin in Patients With StablE Diabetes: APPEASED Study Phase 1

This study tests whether taking a daily low-dose enteric-coated aspirin can improve blood platelet function in people with type 2 diabetes.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Montreal Heart Institute (other)
• Locations: 1 site (Montréal, Quebec)
• Trial ID: NCT05105919 on ClinicalTrials.gov

What this trial studies

This early phase 1 trial investigates the pharmacokinetics and pharmacodynamics of enteric-coated aspirin at a daily dose of 80 mg in patients with type 2 diabetes mellitus. The study aims to assess the feasibility of a larger trial by measuring platelet function before and after a 7-day treatment period. Participants will undergo blood tests to evaluate platelet aggregation and serum salicylate concentration. The findings will help determine the prevalence of incomplete platelet inhibition in this patient population.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with type 2 diabetes who have not used aspirin in the past three months.

Not a fit: Patients with a definitive indication for aspirin or those with known hypersensitivity to aspirin may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the effectiveness of aspirin in managing platelet function in patients with type 2 diabetes.

How similar studies have performed: While similar studies have explored aspirin's effects in various populations, this specific approach in type 2 diabetes is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years;
2. Participant must be naïve to aspirin, defined as absence of chronic treatment with aspirin within the previous 3 months, and of any aspirin 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/mol);
4. Willing to attend all study visits.

Exclusion Criteria:

1. Definitive indication for aspirin, including any evidence of atherosclerotic disease, previous or current;
2. Known hypersensitivity to aspirin;
3. High-risk GI bleeding features, such as known H. pylori infection, past or present ulcer, history of bleeding from the GI tract;
4. Bleeding diathesis;
5. History of hematological malignancy or myelodysplasia;
6. Platelet count or hemoglobin levels outside of the normal reference range;
7. Planned major surgical procedure within 30 days of enrolment;
8. Chronic inflammatory disease requiring regular anti-inflammatory treatment;
9. Chronic treatment with an oral anticoagulant, an antiplatelet agent, NSAIDs or systemic steroids;
10. Active cancer;
11. Pregnant or lactating women.

Where this trial is running

Montréal, Quebec

• Montreal Heart Institute — Montréal, Quebec, Canada (RECRUITING)

Study contacts

• Principal investigator: Guillaume Marquis-Gravel, MD, MSc — Montreal Heart Institute
• Study coordinator: Guillaume Marquis Gravel, MD, MSc

Conditions: Diabetes Mellitus, Type 2, Diabetes, Aspirin, Acetylsalicylic acid, Pharmacodynamics