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

Platelet Dysfunction Due to Drugs Clinical Trial

— EFFECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04342819
• Other study ID #: CREC-SA.0054/10/2019
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2023
• Source: The University of The West Indies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Platelet Dysfunction Due to Drugs

Intervention

Drug:
• SGLT2 inhibitor
Sodium-Glucose Like Transporter 2 Inhibitor

Locations

Country	Name	City	State
Trinidad and Tobago	Eric Williams Medical Sciences Complex	Port Of Spain	North

Sponsors (1)

Lead Sponsor	Collaborator
The University of The West Indies

Country where clinical trial is conducted

Trinidad and Tobago, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet Reaction Units	Platelet Reaction Units post-Empagliflozin	14 days