- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04342819
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
Conditions
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
- Name: Naveen A Seecheran, MBBS, MSc
- Phone Number: 1-868-663-4332
- Email: naveen.seecheran@sta.uwi.edu
Study Contact Backup
- Name: Stanley L Giddings, MBBS
- Phone Number: 1-868-663-4332
- Email: stanley.giddings@sta.uwi.edu
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:
- 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.
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:
|
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- CREC-SA.0054/10/2019
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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