CAD - Coronary Artery DiseasePhase 4EMPANTINFLAMNCT07292909
Effect of Empagliflozin on Inflammation
A Phase 4 study testing Empagliflozin (SGLT2i) in people with CAD - Coronary Artery Disease and Inflamation, run by Hotel Dieu de France Hospital at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CAD - Coronary Artery Disease, Inflamation, PCI
- What is being tested?
- Empagliflozin (SGLT2i)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Sep 2025to 30 Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Patients with stable CAD who are electively scheduled for PCI on a de novo lesion in a native coronary artery
Who cannot join
- • 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…)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lebanon1 site, 1 recruiting
- Recruiting
Hotel Dieu de France
Beirut, Beirut, 00000
Georges Dabar, MD, +9611615300, georges.dabar@usj.edu.lb
Louisette Joubran, +9611615300, louisette.joubran@hdf.esj.edu.lb
About this study
Official title: Randomized Trial to Evaluate the Anti-inflammatory Effects of Empagliflozin Following PCI
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.
Read more
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.
- Conditions
- CAD - Coronary Artery Disease, Inflamation, PCI, SGLT 2 Inhibitors
- Being tested
- Empagliflozin (SGLT2i), Placebo
- Keywords
- CAD, inflammation, SGLT2 inhibitors
- Medical subject headings
- Coronary Artery Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin (SGLT2i)Drug
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
PlaceboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| empagliflozin | Active comparator | Patients who will receive empagliflozin Receives: Drug: Empagliflozin (SGLT2i) |
| Placebo | Placebo comparator | Placebo control Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRP change
High sensitivity CRP will be measured immediately before and 18-24 hours after PCI
Measured: baseline and 18-24 hours after pci
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start1 Sep 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CAD - Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hotel Dieu de France Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabih Azar, Hotel Dieu de France Hospital
- Investigators
- Rabih R Azar, MD, MPH, Principal investigator, Hotel Dieu de Frace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292909
- Sponsor's protocol ID
- CEHDF 2511
- Acronym
- EMPANTINFLAM
- Status last verified
- Dec 2025
- First submitted
- 6 Dec 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We can share all patients data: demographics, characteristics of intervention, markers levels before and after the procedure
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial to Evaluate the Anti-inflammatory Effects of Empagliflozin Following PCI
- ClinicalTrials.gov ID
- NCT07292909
- Acronym / sponsor ID
- EMPANTINFLAM / CEHDF 2511
- Conditions
- CAD - Coronary Artery Disease, Inflamation, PCI, SGLT 2 Inhibitors
- Keywords
- CAD, inflammation, SGLT2 inhibitors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hotel Dieu de France HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| empagliflozin | Active comparator | Drug: Empagliflozin (SGLT2i)Patients who will receive empagliflozin |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- • Patients with stable CAD who are electively scheduled for PCI on a de novo lesion in a native coronary artery
Key exclusion criteria (7 listed)
- • Patients who have been taking an SGLT-2 inhibitor during the last month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | empagliflozin |
| PlaceboPatient 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 | Drug | Placebo |
Primary outcome
CRP change
Time frame: baseline and 18-24 hours after pci
High sensitivity CRP will be measured immediately before and 18-24 hours after PCI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: Yes. We can share all patients data: demographics, characteristics of intervention, markers levels before and after the procedure
Related trials for CAD - Coronary Artery Disease
Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
Active, not recruitingPhase 3
Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events
Coronary Artery Disease
Active, not recruiting
Troponin in Acute Chest Pain to Risk Stratify and Guide EffecTive Use of Computed Tomography Coronary Angiography
Coronary Artery Disease
Recruiting
A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium (The Optimal Trial)
Cardiovascular Diseases, Myocardial Ischemia
Active, not recruitingPhase 4
Comparison of Moderate-Intensity Statin Plus Ezetimibe vs. High-Intensity Statin for Coronary Plaque Stabilization
Coronary Artery Disease, Atherosclerosis of Coronary Artery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rabih R Azar, MD, MPH principal investigator
Hotel Dieu de Frace
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Empagliflozin (SGLT2i) in people with CAD - Coronary Artery Disease and Inflamation, run by Hotel Dieu de France Hospital at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rabih R Azar, MD, MPH (+9613590999, razarmd@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRP change (time frame: baseline and 18-24 hours after pci). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.