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

NCT ID: NCT04400760

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2022-06-30

Brief 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.

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.

Conditions

Platelet Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DAPA Tx

This arm will comprise the participants who are administered Dapagliflozin 10mg per oral once daily for 2 weeks.

Group Type: OTHER

DAPA Tx

Intervention Type: DRUG

The intervention, dapagliflozin will be administered 10mg per oral daily for two weeks.

Interventions

DAPA Tx

The intervention, dapagliflozin will be administered 10mg per oral daily for two weeks.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of The West Indies

OTHER

Sponsor Role: lead

Responsible Party

Naveen Seecheran

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Naveen A Seecheran, MBBS MSc

Role: PRINCIPAL_INVESTIGATOR

The University of The West Indies

Locations

Eric Williams Medical Sciences Complex

Port of Spain, North Central, Trinidad and Tobago

Countries

Trinidad and Tobago

References

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.

Reference Type: DERIVED

PMID: 34643895 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CREC-SA.0284/03/2020

Identifier Type: -

Identifier Source: org_study_id