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

Platelet Dysfunction Clinical Trial

— EDGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04400760
• Other study ID #: CREC-SA.0284/03/2020
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 1, 2020
• Est. completion date: June 30, 2022

Study information

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

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• 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,

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.

Related Conditions & MeSH terms

• Platelet Dysfunction

Intervention

Drug:
• DAPA Tx
The intervention, dapagliflozin will be administered 10mg per oral daily for two weeks.

Locations

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

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 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