Diabetes Mellitus, Type 2 Clinical Trial
— APPEASEDOfficial title:
Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin in Patients With StablE Diabetes: APPEASED Study Phase 1
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | July 1, 2024 |
Est. primary completion date | April 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Montreal Heart Institute | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Montreal Heart Institute | Institut de Recherches Cliniques de Montreal |
Canada,
ASCEND Study Collaborative Group; Bowman L, Mafham M, Wallendszus K, Stevens W, Buck G, Barton J, Murphy K, Aung T, Haynes R, Cox J, Murawska A, Young A, Lay M, Chen F, Sammons E, Waters E, Adler A, Bodansky J, Farmer A, McPherson R, Neil A, Simpson D, Pe — View Citation
Bhatt DL, Grosser T, Dong JF, Logan D, Jeske W, Angiolillo DJ, Frelinger AL 3rd, Lei L, Liang J, Moore JE, Cryer B, Marathi U. Enteric Coating and Aspirin Nonresponsiveness in Patients With Type 2 Diabetes Mellitus. J Am Coll Cardiol. 2017 Feb 14;69(6):60 — View Citation
Lordkipanidze M, Pharand C, Schampaert E, Palisaitis DA, Diodati JG. Heterogeneity in platelet cyclooxygenase inhibition by aspirin in coronary artery disease. Int J Cardiol. 2011 Jul 1;150(1):39-44. doi: 10.1016/j.ijcard.2010.02.025. Epub 2010 Mar 7. — View Citation
Marquis-Gravel G, Roe MT, Harrington RA, Munoz D, Hernandez AF, Jones WS. Revisiting the Role of Aspirin for the Primary Prevention of Cardiovascular Disease. Circulation. 2019 Sep 24;140(13):1115-1124. doi: 10.1161/CIRCULATIONAHA.119.040205. Epub 2019 Se — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incomplete platelet aggregation inhibition by aspirin at 7 days. | Incomplete platelet aggregation inhibition will be defined as = 20% of residual platelet aggregation in response to arachidonic acid at a concentration of 1mM, measured by LTA (Light Transmission Aggregometry). | 7 days. | |
Secondary | Serum levels of thromboxane B2 | Serum levels of thromboxane B2, measured by immunoassay > 3.1 ng/ml will be considered as evidence of recovery of platelet function. | 7 days. | |
Secondary | Platelet aggregation response to various agonists | Platelet reactivity to various agonists such as ADP (Adenosine Diphosphate), TRAP (Thrombin receptor activating peptide), epinephrine and collagen will be assessed by LTA (Light Transmission Agregometry). | 7 days. |
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