The Effect of empagliFlozin on Platelet Function profilEs in diabetiC patienTs - The EFFECT Study.

CREC-SA.0054/10/2019

The mechanistic effects of empagliflozin on platelet function profiles have not yet been ascertained.

2020-01-01

2021-12-31

2021-12-31

Completed

Early phase I

25

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, 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, single-arm, crossover trial design over a 2-year period. Patients at the Eric Williams Medical Sciences Complex (EWMSC), Mt. Hope, Trinidad and Tobago.', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open-Label'}}, 'enrollmentInfo': {'count': 25, 'type': 'ACTUAL'}}

2023-08-25