Rapid cholesterol lowering with Evolocumab in heart attack patients
Effect of Very Early and Rapid Lowering Cholesterol With Evolocumab on Left Ventricular Remodeling in Patients With Anterior ST Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention (EVALUATE-STEMI Trial): a Prospective, Multicenter, Open-label, Adjudicator-blinded, Randomized Clinical Trial
This study tests if quickly lowering cholesterol with a new medication called Evolocumab can help heart attack patients recover better after their procedure.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 330 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Henan Institute of Cardiovascular Epidemiology Academic / other |
| Drugs / interventions | Evolocumab |
| Locations | 6 sites (Gongyi, Henan and 5 other locations) |
| Trial ID | NCT05613426 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of early and rapid cholesterol reduction using the PCSK9 inhibitor Evolocumab in patients experiencing anterior ST elevation myocardial infarction (STEMI) who are undergoing primary percutaneous coronary intervention (PCI). Participants will be randomly assigned to one of three groups: an intensive statin group, a combined statin and Evolocumab group, or a PCSK9 inhibitor group. The goal is to determine if this early intervention can effectively inhibit left ventricular remodeling, which is a common complication following a heart attack.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 experiencing persistent chest pain due to STEMI within 12 hours of onset.
Not a fit: Patients with contraindications to statins or PCSK9 inhibitors, or those with severe acute conditions such as cardiogenic shock or acute heart failure, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve heart function and recovery in patients after a heart attack.
How similar studies have performed: While the use of PCSK9 inhibitors has shown promise in other cardiovascular contexts, this specific early intervention approach in STEMI patients is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-75 years * Persistent chest pain or chest discomfort * Onset within 12 hours * ST-segment elevation ≥0.1 millivolt in two adjacent precordial leads, or a new-onset left bundle branch block with dynamic changes * Primary PCI is planned Exclusion Criteria: * Contraindications to Statins or PCSK9 inhibitors * Prior intravenous thrombolytic therapy * Prior use of Statins, PCSK9 inhibitors or Ezetimibe * Cardiogenic shock * Acute heart failure or pulmonary edema * Prior chronic heart failure * Severe hepatic and renal insufficiency (alanine aminotransferase ≥5 upper limit of normal; estimated glomerular filtration rate \<30ml/min/1.73m2, or on dialysis) * Prolonged (\> 20 minutes) cardiopulmonary resuscitation * Definite mechanical complications (including ventricular septal perforation, or rupture of the Papillary tendon bundle, or rupture of the left ventricular free wall) * Malignant arrhythmias that are difficult to control with drugs * Severe chronic obstructive pulmonary disease or respiratory failure * Severe infection * Neurological disorders * Bleeding history of cerebrovascular, gastrointestinal, respiratory, urinary or other organs within the last month * Active bleeding or bleeding diatheses * Use of anticoagulants * Malignant tumors or other pathophysiological conditions with an expected survival time of less than 1 year * Pregnant or lactating women
Where this trial is running
Gongyi, Henan and 5 other locations
- The People's Hospital of Gongyi — Gongyi, Henan, China (Recruiting)
- Kaifeng Central Hospital — Kaifeng, Henan, China (Recruiting)
- The People's Hospital of Changyuan — Xinxiang, Henan, China (Recruiting)
- Hopeshine Minsheng Hospital of Xinzheng — Xinzheng, Henan, China (Recruiting)
- The People's Hospital of Xuchang — Xuchang, Henan, China (Recruiting)
- Fuwai Central China Cardiovascular Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
Study contacts
- Study coordinator: You Zhang, Doctor
- Email: youzhangww@hotmail.com
- Phone: +86 37158681037
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.