The Effect of Dapagliflozin on Platelet Function testinG Profiles in Diabetic PatiEnts: The EDGE Study.

CREC-SA.0284/03/2020

Sodium GLucose Transport 2 inhibitors (SGLT2I), including dapagliflozin, reduce the likelihood of hospitalization for heart failure and death in persons with type 2 diabetes, of which the mechanism has not been fully elucidated. The mechanistic effects of dapagliflozin on platelet function profiles have not yet been ascertained. It remains unclear if this reduction in cardiovascular death is mediated by decreased platelet reactivity.

2020-05-01

2022-06-30

2022-06-30

Completed

Early phase I

40

Inclusion Criteria: 1. between 18 and 74 years of age, 2. have stable coronary artery disease and diabetes mellitus, already on DAPT with aspirin and clopidogrel for at least 6 months, 3. not on any physician-prescribed medications or complementary/alternative therapies. Exclusion Criteria: 1. presence of active internal bleeding or history of bleeding diathesis or clinical findings associated with an increased risk of bleeding, 2. history of ischemic or hemorrhagic stroke, transient ischemic attack, intracranial neoplasm, arteriovenous malformation, or aneurysm, 3. history of clinical and/or hemodynamic instability, 4. within 1 month of placement of a bare-metal stent, 5. within 30 days of coronary artery bypass graft surgery or PCI without a stent placed, 6. planned coronary revascularization, 7. treatment with fibrin-specific fibrinolytic therapy \<24 h or non-fibrin-specific fibrinolytic therapy \<48 h, 8. use of an oral anticoagulation agent or international normalized ratio \>1.5, 9. body weight \<60 kg, 10. age \>75 years, 11. hemoglobin \<10 g/dL, 12. platelet count \<100×106/μL, 13. creatinine \>2 mg/dL, 14. hepatic enzymes \>2.5 times the upper limit of normal, 15. pregnancy and/or lactation.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The study will be of a prospective, open-label trial design over a 2-year period. Patients at the Eric Williams Medical Sciences Complex (EWMSC), Mt. Hope, Trinidad and Tobago will be screened for potential eligibility.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}

2023-11-07