Effect of Empagliflozin on Inflammation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Empagliflozin (SGLT2i), Placebo.
- Who it may be relevant to
- Registry conditions: CAD - Coronary Artery Disease, Inflamation, PCI, SGLT 2 Inhibitors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Lebanon
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Trial to Evaluate the Anti-inflammatory Effects of Empagliflozin Following PCI
Overview
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.
Interventions
- 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 - 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
Primary outcome measures
- CRP change [Time frame: baseline and 18-24 hours after pci]
Eligibility criteria
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…)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Lebanon · 1 center
- Hotel Dieu de France — Beirut
Identifiers
NCT: NCT07292909 · CEHDF 2511