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

NCT04342819 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CREC-SA.0054/10/2019
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Platelet Dysfunction Due to Drugs

Outcome Measures

Primary Outcomes (1)

• P2Y12 Reaction Units

  P2Y12 Reaction Units post-Empagliflozin. Citrated blood samples are processed by CRAs and study investigators. The platelet function assay to be utilized is the VerifyNow P2Y12 (VN-P2Y12) assay (Accriva, San Diego, California). In brief, the VN-P2Y12 assay is a rapid whole blood point-of-care device that reports results as P2Y12 reaction units (PRU) and percent inhibition of platelet aggregation (%IPA). Assays will be performed as per the instructions of the manufacturer previously described.

  14 days

Study Arms (1)

SGLT2i

EXPERIMENTAL

Empagliflozin 25 mg per oral once daily

Drug: SGLT2 inhibitor

Interventions

SGLT2 inhibitor DRUG

Sodium-Glucose Like Transporter 2 Inhibitor

Also known as: Empagliflozin

SGLT2i

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• 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,

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, 00000, Trinidad and Tobago

Location

Related Publications (1)

• Seecheran N, Ramdeen A, Debideen N, Ali K, Grimaldos K, Grimaldos G, Karan A, Seecheran R, Seecheran V, Persad S, Abdullah H, Peram L, Giddings S, Motilal S, Tello-Montoliu A, Schneider D. The Effect of Empagliflozin on Platelet Function Profiles in Patients with Stable Coronary Artery Disease in Trinidad: The EFFECT Pilot Study. Cardiol Ther. 2021 Jun;10(1):189-199. doi: 10.1007/s40119-020-00208-0. Epub 2020 Dec 11.

  PMID: 33306161 DERIVED

MeSH Terms

Interventions

Sodium-Glucose Transporter 2 Inhibitors; empagliflozin

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Results Point of Contact

• Title: Naveen Seecheran, Senior Lecturer
• Organization: The University of the West Indies

Naveen.Seecheran@sta.uwi.edu

18687537686

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Open-Label
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 13, 2020
• Study Start: January 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: September 3, 2024
• Results First Posted: September 3, 2024

Record last verified: 2024-08

Locations

TR (1)