Empagliflozin to reduce inflammation after coronary stenting
Randomized Trial to Evaluate the Anti-inflammatory Effects of Empagliflozin Following PCI
This trial will test whether taking empagliflozin for three days before elective PCI reduces the rise in C‑reactive protein and other inflammatory markers in people with stable coronary artery disease.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hotel Dieu de France Hospital Academic / other |
| Locations | 1 site (Beirut, Beirut) |
| Trial ID | NCT07292909 on ClinicalTrials.gov |
What this trial studies
Adults with stable coronary artery disease scheduled for elective percutaneous coronary intervention (PCI) will receive either empagliflozin or a matching placebo for three days before the procedure. Blood will be drawn before the intervention and again 24 hours after stenting to measure C‑reactive protein and other inflammatory markers. The primary goal is to see if empagliflozin blunts the post‑procedural rise in CRP compared with placebo. Key exclusions include recent SGLT2 inhibitor use, active inflammatory disease or infection, recent acute coronary syndrome, severe renal impairment, and procedures requiring specialized devices.
Who should consider this trial
Good fit: Ideal candidates are adults with stable coronary artery disease scheduled for elective PCI on a native de novo coronary lesion who are not currently taking an SGLT2 inhibitor and have adequate kidney function.
Not a fit: Patients with recent acute coronary syndrome, active inflammatory or infectious disease, recent SGLT2 inhibitor use, creatinine clearance <30 mL/min, interventions on restenotic lesions or grafts, or those requiring complex devices are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could show empagliflozin reduces periprocedural inflammation after stenting and help explain some cardiovascular benefits beyond blood sugar lowering.
How similar studies have performed: Large outcome trials have shown empagliflozin improves heart failure and cardiovascular outcomes and smaller clinical and preclinical studies suggest anti‑inflammatory effects, but using peri‑PCI CRP rise as a test of this effect is a relatively novel application.
Eligibility criteria
Show full inclusion / exclusion 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…)
Where this trial is running
Beirut, Beirut
- Hotel Dieu de France — Beirut, Beirut, Lebanon (Recruiting)
Study contacts
- Principal investigator: Rabih R Azar, MD, MPH — Hotel Dieu de Frace
- Study coordinator: Rabih R Azar, MD, MPH
- Email: razarmd@hotmail.com
- Phone: +9613590999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.