Effect of Empagliflozin on Inflammation (EMPANTINFLAM)

Hotel Dieu de France Hospital

Status and phase: Enrolling; Phase 4

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

Treatments: Drug: Empagliflozin (SGLT2i); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07292909

CEHDF 2511

Details and patient eligibility

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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…)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

empagliflozin

Active Comparator group

Description:

Patients who will receive empagliflozin

Treatment:

Drug: Empagliflozin (SGLT2i)

Placebo

Placebo Comparator group

Description:

Placebo control

Treatment:

Drug: Placebo