Actively Recruiting
Randomized Trial to Evaluate the Anti-inflammatory Effects of Empagliflozin Following PCI
Led by Hotel Dieu de France Hospital · Updated on 2025-12-18
100
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of empagliflozin, a drug commonly used to lower glucose in diabetes treatment, on inflammation in patients with stable coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). Although empagliflozin has shown benefits for heart failure patients, the exact reasons are unclear, and this study aims to explore its possible anti-inflammatory effects using PCI as a model of inflammation. Participants will receive either empagliflozin or a placebo tablet once daily for at least three days before their scheduled PCI procedure. The empagliflozin dose is 10 mg per day, administered orally. The study compares inflammation levels after the procedure by measuring C-Reactive Protein (CRP) and other inflammatory markers before the intervention and 18 to 24 hours afterward, aiming to see if empagliflozin reduces the inflammation response compared to placebo. During the study, patients will have blood samples taken before PCI and about one day later to measure changes in CRP levels and other markers of inflammation. The study uses a randomized, quadruple-masked design to ensure unbiased results. Participants will be monitored for safety and inflammation changes, with the primary outcome focusing on CRP level changes following the PCI procedure. The study runs until September 2027.
CONDITIONS
Brief Title
Effect of Empagliflozin on Inflammation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with stable coronary artery disease who are electively scheduled for PCI on a new blockage in a native coronary artery
You will not qualify if you...
- Patients who have taken an SGLT-2 inhibitor in the last month
- Patients receiving any anti-inflammatory medication such as immunosuppressors, steroids, or NSAIDs
- Patients with underlying inflammatory conditions like rheumatoid arthritis, infection, or active cancer
- Patients with acute coronary syndrome within the last month
- Patients undergoing intervention on a restenotic lesion or a lesion in a saphenous vein graft
- Patients with creatinine clearance less than 30 mL/min
- Patients treated with devices other than balloons and stents, such as lithotripsy or rotational atherectomy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 3 days
Participants receive empagliflozin or placebo daily for at least 2 days prior to the planned PCI procedure.
1 baseline visit (in-person) before treatment starts
Duration - Day of PCI
Participants undergo PCI and continue to receive the assigned drug on the day of PCI.
1 visit (in-person) for PCI and dosing
Duration - 18 to 24 hours after PCI
Participants have assessment of inflammatory markers 18 to 24 hours after PCI to evaluate treatment effect.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Hotel Dieu de France
Beirut, Beirut, Lebanon, 00000
Actively Recruiting
Research Team
R
Rabih R Azar, MD, MPH
G
Georges G Hage, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here