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

NCT ID: NCT04342819

Last Updated: 2024-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2021-12-31

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.

Conditions

Platelet Dysfunction Due to Drugs

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

SGLT2i

Empagliflozin 25 mg per oral once daily

Group Type: EXPERIMENTAL

SGLT2 inhibitor

Intervention Type: DRUG

Sodium-Glucose Like Transporter 2 Inhibitor

Interventions

SGLT2 inhibitor

Sodium-Glucose Like Transporter 2 Inhibitor

Intervention Type: DRUG

Other Intervention Names

Empagliflozin

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of The West Indies

OTHER

Sponsor Role: lead

Responsible Party

Naveen Seecheran

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Eric Williams Medical Sciences Complex

Port of Spain, North, Trinidad and Tobago

Countries

Trinidad and Tobago

References

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.

Reference Type: DERIVED

PMID: 33306161 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CREC-SA.0054/10/2019

Identifier Type: -

Identifier Source: org_study_id