Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT07292909

Effect of Empagliflozin on Inflammation

Led by Hotel Dieu de France Hospital · Updated on 2025-12-18

100

Participants Needed

1

Research Sites

108 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

Effect of Empagliflozin on Inflammation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with stable CAD who are electively scheduled for PCI on a de novo lesion in a native coronary artery
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Patients who have been taking an SGLT-2 inhibitor during the last month
  • Patients who are receiving any anti-inflammatory medication such as immunosuppressors, steroids, or NSAIDs
  • Patients with underlying inflammatory conditions such as rheumatoid arthritis, infection, or 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 treated with devices other than balloons and stents (e.g., lithotripsy, rotational atherectomy)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hotel Dieu de France

Beirut, Beirut, Lebanon, 00000

Actively Recruiting

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Research Team

R

Rabih R Azar, MD, MPH

CONTACT

G

Georges G Hage, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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