Effect of Empagliflozin on Inflammation

NCT07292909 | Recruiting Phase 4

• 1 other identifier: CEHDF 2511
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Empagliflozin is a drug given to lower glucose. It is used in the treatment of diabetes. However, it was shown to improve symptoms and survival of patients who are suffering from heart failure. The exact mechanism of this effect is currently not clearly understood. He hypothesize that empagliflozin has other properties than glucose lowering, that can explain its efficacy. One of these properties, is an anti-inflammatory effect. To document this, we are using a model of inflammation following percutaneous coronary scenting. We know that patients who get a stent will develop inflammation following stenting. This is documenting by a higher level of C-Reactive Protein 24 hours after the procedure. Patients who will participate in the study, will receive empagliflozin or a placebo tablet for 3 days prior to the revascularisation procedure. CRP and other inflammatory markers will be measured before intervention and 24 hours later. The goal is to demonstrate a lower rise in CRP following intervention in patients treated with empagliflozin vs. those who have received a placebo.

Conditions

CAD - Coronary Artery Disease; Inflamation; PCI; SGLT 2 Inhibitors

Keywords

CAD; inflammation; SGLT2 inhibitors

Outcome Measures

Primary Outcomes (1)

• CRP change

  High sensitivity CRP will be measured immediately before and 18-24 hours after PCI

  baseline and 18-24 hours after pci

Study Arms (2)

empagliflozin

ACTIVE COMPARATOR

Patients who will receive empagliflozin

Drug: Empagliflozin (SGLT2i)

Placebo

PLACEBO COMPARATOR

Placebo control

Drug: Placebo

Interventions

Empagliflozin (SGLT2i) DRUG

Patient will receive 10 mg of empagliflozin PO per day, starting at least 2 days before planned PCI and on the day of PCI. Patient will thus receive at least 3 doses of empagliflozin prior to intervention

empagliflozin

Placebo DRUG

Patient will receive a matching placebo PO 1 tab per day, starting at least 2 days before planned PCI and on the day of PCI. Patient will thus receive at least 3 doses of empagliflozin prior to intervention

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with stable CAD who are electively scheduled for PCI on a de novo lesion in a native coronary artery

You may not qualify if:

• Patients who have been taking an SGLT-2 inhibitor during the last month
• Patients who are receiving any anti-inflammatory medication: immunosuppressor, steroids, NSAID…
• Patients who have underlying inflammatory conditions such as rheumatic arthritis, infection, active malignancy
• Patients with an acute coronary syndrome within the last month
• Intervention on a restenotic lesion or lesion in a saphenous vein graft
• Creatinine clearance less than 30 mL/min
• Patients who are treated with devices other than balloons and stents (lithotripsy, rotational atherectomy…)

Sponsors & Collaborators

• Hotel Dieu de France Hospital: lead

Study Sites (1)

Hotel Dieu de France

Beirut, Beyrouth, 00000, Lebanon

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Inflammation

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rabih R Azar, MD, MPH

  Hotel Dieu de Frace

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rabih R Azar, MD, MPH

CONTACT

+9613590999; razarmd@hotmail.com

Georges G Hage, MD

CONTACT

+9613284724; georgesjuniorhage@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 6, 2025
• First Posted: December 18, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: At end of study and for at least 3 years after completion
• Access Criteria: Investigators, journal editors. They can contact us via email

Locations

LE (1)