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

Study Overview
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Brief Summary
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The mechanistic effects of empagliflozin on platelet function profiles have not yet been ascertained.

Detailed Description
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Sodium GLucose Transport 2 inhibitors (SGLT2I), including empagliflozin, 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 empagliflozin on platelet function profiles have not yet been ascertained. It remains unclear if this reduction in cardiovascular death is mediated by decreased platelet reactivity.

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

Conditions
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Platelet Dysfunction Due to Drugs

Intervention / Treatment
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* Drug: SGLT2 inhibitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: between 18 and 74 years of age, have stable coronary artery disease and diabetes mellitus, already on DAPT with aspirin and clopidogrel for at least 6 months, Exclusion Criteria: presence of active internal bleeding or history of bleeding diathesis or clinical findings associated with an increased risk of bleeding, history of ischemic or hemorrhagic stroke, transient ischemic attack, intracranial neoplasm, arteriovenous malformation, or aneurysm, history of clinical and/or hemodynamic instability, within 1 month of placement of a bare metal stent, within 30 days of coronary artery bypass graft surgery or PCI without a stent placed, planned coronary revascularization, treatment with fibrin-specific fibrinolytic therapy <24 h or non-fibrin-specific fibrinolytic therapy <48 h, use of an oral anticoagulation agent or international normalized ratio >1.5, body weight <60 kg, age >75 years, hemoglobin <10 g/dL, platelet count <100×106/μL, creatinine >2 mg/dL, hepatic enzymes >2.5 times the upper limit of normal, pregnancy and/or lactation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SGLT2i<br>Empagliflozin 25 mg per oral once daily | Drug: SGLT2 inhibitor<br>* Sodium-Glucose Like Transporter 2 Inhibitor<br>* Other names: Empagliflozin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet Reaction Units | Platelet Reaction Units post-Empagliflozin | 14 days |