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NCT Number: NCT07292909

Effect of Empagliflozin on Inflammation

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.

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Key information

Conditions

CAD - Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Inflamation Inflammation Myocardial Ischemia PCI Pathologic Processes Pathological Conditions, Signs and Symptoms SGLT 2 Inhibitors Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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…)

Treatment and study plan

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

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

Primary outcomes

  1. CRP change

    Time frame: baseline and 18-24 hours after pci

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

Study contacts

Contact information is provided by the study sponsor or research team.

Georges G Hage, MD

CONTACT

[email protected]

+9613284724

Rabih R Azar, MD, MPH

CONTACT

[email protected]

+9613590999

Sponsors and collaborators

Lead sponsor

Hotel Dieu de France Hospital

Other

Registry information

Official study title

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

Acronym: EMPANTINFLAM

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 18, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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