The Effect of Dapagliflozin on Platelet Function testinG Profiles in Diabetic PatiEnts. (EDGE)

The Effect of Dapagliflozin on Platelet Function testinG Profiles in Diabetic PatiEnts: The EDGE Study.

Sodium GLucose Transport 2 inhibitors (SGLT2I), including dapagliflozin, 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 dapagliflozin 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 Overview

• Status: Completed
• Conditions: Platelet Dysfunction
• Intervention / Treatment: Drug: DAPA Tx

Detailed Description

Diabetes is highly prevalent in our setting. Dapagliflozin is now considered first-line treatment for diabetes, especially in the cardiovascular arena. The standard prescribed dosages of dapagliflozin will be employed in the research study (5 or 10 mg once daily). The reason the study team is interested in performing this study in our local setting is that if dapagliflozin does show a beneficial effect with either diabetic control or an antiplatelet effect, the team can then inform the Ministry of Health to acquire these relatively expensive medications in place of the older, less effective anti-diabetic drugs. The team has to demonstrate that they work effectively and safely in our population before approaching regulatory bodies with a robust recommendation that they are made available in the public healthcare sector. The patients that are to be selected will be relatively controlled on their current regimen, and thus not "miss out" on these medications after the study has been concluded as they are all available on the chronic disease assistance program (CDAP) such as metformin, gliclazide and insulin therapies. The study will aim to determine if dapagliflozin does demonstrate other latent antiplatelet effects that can potentially affect the cardiovascular/hematologic systems that have not investigated before.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Naveen A Seecheran, MBBS MSc; Phone Number: 0000 1-868-753-7686; Email: nseecheran@gmail.com
• Study Contact Backup: Name: Lakshimipatty Peram, MBBS; Phone Number: 0000 1-868-760-0369; Email: lakshperam@yahoo.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

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,
3. not on any physician-prescribed medications or complementary/alternative therapies.

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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: DAPA Tx; This arm will comprise the participants who are administered Dapagliflozin 10mg per oral once daily for 2 weeks.	Drug: DAPA Tx; The intervention, dapagliflozin will be administered 10mg per oral daily for two weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Platelet Reactions Units Pre-DAPA Tx and Post-DAPA Tx	Platelet Reaction units at baseline and post-DAPA Tx treatment with dapagliflozin	Baseline (0 weeks) to Completion (2 weeks) after Dapagliflozin

Collaborators and Investigators

• Sponsor: The University of The West Indies
• Investigators: Principal Investigator: Naveen A Seecheran, MBBS MSc, The University of the West Indies

Publications and helpful links

General Publications

• Seecheran N, Grimaldos K, Ali K, Grimaldos G, Richard S, Ishmael A, Gomes C, Karan A, Seecheran R, Seecheran V, Persad S, Abdullah H, Peram L, Dookeeram D, Giddings S, Motilal S, Raza S, Tello-Montoliu A, Schneider D. The Effect of Dapagliflozin on Platelet Function Testing Profiles in Diabetic Patients: The EDGE Pilot Study. Cardiol Ther. 2021 Dec;10(2):561-568. doi: 10.1007/s40119-021-00242-6. Epub 2021 Oct 13.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: May 19, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 26, 2020

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: SGLT2i; dapagliflozin
• Other Study ID Numbers: CREC-SA.0284/03/2020

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