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

ICM 2021-2919

This phase 1 study will include patients suffering from type 2 diabetes mellitus and will study their response to enteric coated aspirin at a dose of 80 mg per day for a 7-day period. The aims are to determine the feasibility of a phase 2 larger scale trial, and to characterize the prevalence of incomplete platelet inhibition after exposure to EC aspirin at doses of 80 mg once daily. Platelet function will be assessed at baseline and a day 7.

2021-08-26

2024-04-01

2024-07-01

Recruiting

Early phase I

50

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a single arm open-label feasibility phase 1 trial. The aim of the study if to determine the number of potentially eligible participants and the monthly recruitment rate at the MHI (Montreal Heart Institute), the Centre Épic and the IRCM (Institut de recherche clinique de Montréal) as well as participants adherence to study protocol to determine feasibility of a phase 2 trial within these centers.', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'All enrolled participants will receive the same treatment.'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

2024-03-15