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

NCT04400760 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CREC-SA.0284/03/2020
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Platelet Dysfunction

Keywords

dapagliflozin; SGLT2i

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

DAPA Tx

OTHER

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

Drug: DAPA Tx

Interventions

DAPA Tx DRUG

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

DAPA Tx

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of The West Indies: lead

Study Sites (1)

Eric Williams Medical Sciences Complex

Port of Spain, North Central, 00000, Trinidad and Tobago

Location

Related Publications (1)

• 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.

  PMID: 34643895 DERIVED

Results Point of Contact

• Title: Dr. Naveen Seecheran
• Organization: The University of the West Indies, St. Augustine

nseecheran@gmail.com

18687537686

Study Officials

• Naveen A Seecheran, MBBS MSc

  The University of The West Indies

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study will be of a prospective, open-label trial design over a 2-year period. Patients at the Eric Williams Medical Sciences Complex (EWMSC), Mt. Hope, Trinidad and Tobago will be screened for potential eligibility.

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 26, 2020
• Study Start: May 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: November 7, 2023
• Results First Posted: November 7, 2023

Record last verified: 2023-10

Locations

TR (1)