Effect of Very Early and Rapid Lowering Cholesterol With Evolocumab on Left Ventricular Remodelin… (NCT05613426) | Clinical Trial Compass
TerminatedPhase 4
Effect of Very Early and Rapid Lowering Cholesterol With Evolocumab on Left Ventricular Remodeling in Patients With Anterior STEMI Undergoing Primary PCI
Stopped: Slow patient enrollment and lack of financial support
China119 participantsStarted 2023-04-03
Plain-language summary
For patients with anterior ST elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), whether early application of proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors to rapidly reduce low-density lipoprotein cholesterol (LDL-C) before PCI could effectively inhibit left ventricular remodeling has been rarely reported. The aim of this study was to investigate the effect of early application of PCSK9 inhibitors Evolocumab to rapidly reduce LDL-C levels before primary PCI treatment on left ventricular remodeling in STEMI patients.
Eligible patients were randomly randomized 1:1:1 to one of the following three groups immediately after enrollment: (1) Intensive statin group: rosuvastatin 20 mg per day, in addition to usual therapy; (2) Combined intensive statin and PCSK9 inhibitor group: rosuvastatin 20 mg per day and subcutaneous injection of evolocumab 140 mg twice a month, for at least 3 months, and preferably 6 months; (3) PCSK9 inhibitor alone group: subcutaneous injection of evolocumab 140 mg, twice a month for at least 3 months and preferably 6 months.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in left ventricular ejection fraction (LVEF)
Timeframe: Baseline and 12 weeks
Trial details
NCT IDNCT05613426
SponsorHenan Institute of Cardiovascular Epidemiology