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

August 23, 2023 updated by: Naveen Seecheran, The University of The West Indies
The mechanistic effects of empagliflozin on platelet function profiles have not yet been ascertained.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • North
      • Port Of Spain, North, Trinidad and Tobago, 00000
        • Eric Williams Medical Sciences Complex

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SGLT2i
Empagliflozin 25 mg per oral once daily
Sodium-Glucose Like Transporter 2 Inhibitor
Other Names:
  • Empagliflozin

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

April 8, 2020

First Submitted That Met QC Criteria

April 8, 2020

First Posted (Actual)

April 13, 2020

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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