Using empagliflozin to prevent no-reflow in heart attack patients
Empagliflozin for Reducing the Risk of No-Reflow Phenomenon in Patients Undergoing Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction
PHASE2 · Instituto Nacional de Cardiologia Ignacio Chavez · NCT06342141
This study tests if the diabetes drug empagliflozin can help heart attack patients avoid complications during treatment by improving blood flow after their procedure.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 162 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Instituto Nacional de Cardiologia Ignacio Chavez (other) |
| Locations | 1 site (Mexico City) |
| Trial ID | NCT06342141 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of empagliflozin, a medication originally developed for diabetes, on the no-reflow phenomenon in patients experiencing ST-segment elevation myocardial infarction (STEMI) undergoing coronary angioplasty. Participants will receive empagliflozin either 25 mg or 10 mg starting before the intervention and continuing for three days afterward. The study aims to determine if this treatment can reduce reperfusion injury, which is a significant contributor to poor outcomes in heart attack patients. The trial is randomized and parallel-arm, allowing for a comparison between the two dosages.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with acute myocardial infarction with ST-segment elevation who present within 12 hours of symptom onset and have a known diagnosis of diabetes or elevated admission glucose.
Not a fit: Patients who are hemodynamically unstable, undergoing thrombolysis, or have a history of certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery outcomes for heart attack patients by reducing reperfusion injury.
How similar studies have performed: While empagliflozin has shown promise in animal models, there are currently no human studies confirming its effects on the no-reflow phenomenon, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Acute myocardial infarction with ST-segment elevation * Presentation to the institute within 12 hours of symptom onset * Coronary angioplasty chosen as the reperfusion treatment for the subject * Known diagnosis of diabetes or admission glucose \>180 mg/dl. * Informed consent signed Exclusion Criteria: * Hemodynamically unstable subjects * Subjects undergoing thrombolysis treatment in the current event * History of coronary revascularization surgery * Known allergy or hypersensitivity to Sodium-glucose co-transporter-2 (SGLT2) inhibitors * History of recurrent urinary tract infections * Known chronic kidney disease and estimated glomerular filtration rate (eGFR) \< 20 * Ongoing treatment with any SGLT2 inhibitor * Participation in another clinical trial or having participated in the week prior to recruitment * For women of childbearing age: Current or planned pregnancy or lactation.
Where this trial is running
Mexico City
- National Institute of Cardiology — Mexico City, Mexico (RECRUITING)
Study contacts
- Principal investigator: Eduardo Arias-Sanchez, MD — Deputy Head of the Department of Interventional Cardiology at the National Institute of Cardiology
- Study coordinator: Fabio Solis-Jimenez, MD, MSc
- Email: fabiosolisjimenez@gmail.com
- Phone: +525540838443
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.
Conditions: STEMI, No-Reflow Phenomenon