Effect of Empagliflozin on Inflammation (EMPANTINFLAM)

Randomized Trial to Evaluate the Anti-inflammatory Effects of Empagliflozin Following PCI

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.

Study Overview

• Status: Recruiting
• Conditions: PCI; CAD - Coronary Artery Disease; SGLT 2 Inhibitors; Inflamation
• Intervention / Treatment: Drug: Empagliflozin (SGLT2i); Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Rabih R Azar, MD, MPH; Phone Number: +9613590999; Email: razarmd@hotmail.com
• Study Contact Backup: Name: Georges G Hage, MD; Phone Number: +9613284724; Email: georgesjuniorhage@hotmail.com

Study Locations

• Lebanon
  • Beyrouth
    • Beirut, Beyrouth, Lebanon, 00000
      • Recruiting
      • Hotel Dieu de France
      • Contact: Georges Dabar, MD; Phone Number: +9611615300; Email: georges.dabar@usj.edu.lb
      • Contact: Louisette Joubran; Phone Number: +9611615300; Email: louisette.joubran@hdf.esj.edu.lb
      • Sub-Investigator: Georges Hage, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• • 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…)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo control	Drug: Placebo; 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
Active Comparator: empagliflozin; Patients who will receive empagliflozin	Drug: Empagliflozin (SGLT2i); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRP change	High sensitivity CRP will be measured immediately before and 18-24 hours after PCI	baseline and 18-24 hours after pci

Collaborators and Investigators

• Sponsor: Hotel Dieu de France Hospital
• Investigators: Principal Investigator: Rabih R Azar, MD, MPH, Hotel Dieu de Frace

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: December 6, 2025
• First Submitted That Met QC Criteria: December 6, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 6, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: inflammation; SGLT2 inhibitors; CAD
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Pathological Conditions, Signs and Symptoms; Inflammation; Coronary Artery Disease; empagliflozin
• Other Study ID Numbers: CEHDF 2511

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We can share all patients data: demographics, characteristics of intervention, markers levels before and after the procedure
• IPD Sharing Time Frame: At end of study and for at least 3 years after completion
• IPD Sharing Access Criteria: Investigators, journal editors. They can contact us via email
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No