Effect of Empagliflozin on Inflammation

Sponsor
Hotel Dieu de France Hospital
Study ID
NCT07292909
Phase
PHASE4
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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
  • 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

Study Details

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.

Key Dates

Start date
Sep 1, 2025
Status verified
Dec 2025
Primary completion
Jun 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: empagliflozin
    Patients who will receive empagliflozin
  • Placebo Comparator: Placebo
    Placebo control

Primary Outcome Measure

CRP change [ Time Frame: baseline and 18-24 hours after pci ]

Central Contacts

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