Effects of a cholesterol-lowering drug before heart surgery in heart attack patients
Effects of PCSK-9 Inhibitor Treatment Prior to Undergoing Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction: A Single-center，Randomized,Open-label Trial
This study is testing if giving a cholesterol-lowering drug before heart surgery can help heart attack patients feel better and have better outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Beijing Luhe Hospital Academic / other |
| Drugs / interventions | Evolocumab |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06364124 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of administering evolocumab, a PCSK9 inhibitor, prior to primary percutaneous coronary intervention (PCI) in patients experiencing ST-segment elevation myocardial infarction (STEMI). The research aims to determine if this treatment can effectively lower LDL cholesterol levels and reduce inflammation, potentially improving outcomes for patients undergoing PCI. Participants will be selected from the Cardiology Department of Beijing Luhe Hospital, and the study will focus on those who meet specific criteria related to their heart condition. The goal is to gather data on the cardioprotective effects of evolocumab in this acute setting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 who have experienced STEMI and are undergoing PCI within 24 hours of symptom onset.
Not a fit: Patients with severe renal insufficiency, active liver disease, or those who are hemodynamically unstable will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of early recurrent ischemic events in STEMI patients.
How similar studies have performed: While the use of PCSK9 inhibitors has shown promise in other cardiovascular contexts, data specifically regarding their preoperative use in STEMI patients is limited, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients are selected from the Cardiology Department of Beijing Luhe Hospital and have undergone direct PCI treatment for STEMI. * STEMI patients must meet the following criteria: 1. Chest pain duration ≥ 30 minutes, with ST-segment elevation ≥ 0.1 mV in adjacent two leads on the electrocardiogram. 2. Onset within 24 hours. 3. Aged between 18 and 80 years. 4. Signed informed consent form. Exclusion Criteria: * Hemodynamically unstable or Killip grade ≥ 2. * Severe renal insufficiency: Glomerular filtration rate \< 30 ml/min/1.73m\^2. * Active liver disease or liver dysfunction: AST or ALT levels \> 3 times the upper limit of normal. * Known allergy to any drug used in the study. * Previous or planned use of PCSK9 inhibitors. * Suspected stress cardiomyopathy or acute pericarditis. * Malignant tumors requiring treatment or other severe systemic diseases. * Pregnancy or breastfeeding
Where this trial is running
Beijing
- Beijing luhe hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: rui yan
- Email: yanrui4112@163.com
- Phone: 17746570262
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.