CAD - Coronary Artery Disease, Inflamation, PCI, SGLT 2 Inhibitors
Conditions
Keywords
CAD, inflammation, SGLT2 inhibitors
Brief summary
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
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
DRUGPlacebo
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
Sponsors
Hotel Dieu de France Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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…)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CRP change | baseline and 18-24 hours after pci | High sensitivity CRP will be measured immediately before and 18-24 hours after PCI |
Countries
Lebanon
Contacts
Primary ContactRabih R Azar, MD, MPH
Backup ContactGeorges G Hage, MD
Outcome results
None listed