Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
100 participants
INTERVENTIONAL
2025-09-01
2027-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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empagliflozin
Patients who will receive empagliflozin
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
Placebo
Placebo control
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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…)
18 Years
ALL
No
Sponsors
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Hotel Dieu de France Hospital
OTHER
Responsible Party
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Rabih Azar
Professor of Medicine
Principal Investigators
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Rabih R Azar, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Hotel Dieu de Frace
Locations
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Hotel Dieu de France
Beirut, Beyrouth, Lebanon
Countries
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Central Contacts
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Facility Contacts
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Georges Dabar, MD
Role: primary
Louisette Joubran
Role: backup
Other Identifiers
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CEHDF 2511
Identifier Type: -
Identifier Source: org_study_id