Clincosm LogoSign in Get a demo

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

Sponsor
The University of The West Indies (Other)
Overall Status
Unknown status
CT.gov ID
NCT04342819
Collaborator
(none)
25
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: SGLT2 inhibitor
 Phase 2/Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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.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.
Masking:
None (Open Label)
Masking Description:
Open-Label
Primary Purpose:
Basic Science
Official Title:
The Effect of empagliFlozin on Platelet Function profilEs in diabetiC patienTs - The EFFECT Study.
Actual Study Start Date :
Jan 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: SGLT2i

Empagliflozin 25 mg per oral once daily

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Platelet Reaction Units [14 days]

      Platelet Reaction Units post-Empagliflozin

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Eric Williams Medical Sciences Complex Port Of Spain North Trinidad and Tobago 00000

    Sponsors and Collaborators

    • The University of The West Indies

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Naveen Seecheran, Principal Investigator, The University of The West Indies
    ClinicalTrials.gov Identifier:
    NCT04342819
    Other Study ID Numbers:
    • CREC-SA.0054/10/2019
    First Posted:
    Apr 13, 2020
    Last Update Posted:
    Apr 13, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Additional relevant MeSH terms:
    Empagliflozin
    Sodium-Glucose Transporter 2 Inhibitors

    Study Results

    No Results Posted as of Apr 13, 2020