Clinical trial NCT04342819: The Effect of empagliFlozin on Platelet Function profilEs in diabetiC patienTs - The EFFECT Study.
Official title: The Effect of empagliFlozin on Platelet Function profilEs in diabetiC patienTs - The EFFECT Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Platelet Dysfunction Due to Drugs
Lead sponsor: The University of The West Indies
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: BASIC_SCIENCE

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: P2Y12 Reaction Units
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Port Of Spain
country: Trinidad and Tobago
facility: Eric Williams Medical Sciences Complex
state: North
Study officials:
References:
citation: Seecheran N, Ramdeen A, Debideen N, Ali K, Grimaldos K, Grimaldos G, Karan A, Seecheran R, Seecheran V, Persad S, Abdullah H, Peram L, Giddings S, Motilal S, Tello-Montoliu A, Schneider D. The Effect of Empagliflozin on Platelet Function Profiles in Patients with Stable Coronary Artery Disease in Trinidad: The EFFECT Pilot Study. Cardiol Ther. 2021 Jun;10(1):189-199. doi: 10.1007/s40119-020-00208-0. Epub 2020 Dec 11.