Evolocumab for treating heart attacks
The Effect of Evolocumab on Infarct Size in Patients With ST-segment Elevation Myocardial Infarction; Prospective, Randomized, Open Label, Controlled Trial
PHASE3 · Sejong General Hospital · NCT06081803
This study is testing if a medication called evolocumab can reduce heart damage in people who have had a heart attack and are undergoing a specific treatment.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 166 (estimated) |
| Ages | 30 Years to 80 Years |
| Sex | All |
| Sponsor | Sejong General Hospital (other) |
| Drugs / interventions | evolocumab |
| Locations | 1 site (Bucheon) |
| Trial ID | NCT06081803 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the size of myocardial infarction in patients with ST-segment elevation myocardial infarction (STEMI) receiving evolocumab versus a control group. Participants will undergo primary percutaneous coronary intervention (PCI) and receive a subcutaneous injection of 420 mg of evolocumab before the procedure. A cardiac MRI will be performed four weeks post-reperfusion to assess infarct size. The study seeks to address the issue of myocardial no-reflow and microvascular obstruction that can occur despite successful PCI.
Who should consider this trial
Good fit: Ideal candidates are adults experiencing typical ischemic chest pain lasting more than 30 minutes with ST segment elevation.
Not a fit: Patients with a history of myocardial infarction, coronary bypass surgery, or those in cardiogenic shock may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce myocardial injury and improve recovery outcomes for patients experiencing STEMI.
How similar studies have performed: Previous studies have shown mixed results with similar approaches, indicating that while some treatments have improved outcomes, the specific use of evolocumab in this context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Typical ischemic chest pain persists for more than 30 minutes * An elevation of an ST segment greater than 1 mm in two consecutive leads or new-onset left bundle branch block * Presenting more than 12 hours after the onset of symptoms Exclusion Criteria: * Previous history of myocardial infarction * Previous history of coronary bypass surgery * Cardiogenic shock that lasts more than 10 minutes or cardiac arrest * Occlusion of the left main coronary artery * Pregnant or have a plan of pregnancy * Serum creatinine level is \>2.5mg/dL or dialysis is required
Where this trial is running
Bucheon
- Sejong General Hospital — Bucheon, Korea, Republic of (RECRUITING)
Study contacts
- Study coordinator: Hyun-Jong Lee, MD, PhD
- Email: untouchables00@hanmail.net
- Phone: 82-10-6217-9315
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: ST Elevation Myocardial Infarction, PCSK9, percutaneous coronary intervention, Infarct size