Clinical trial NCT05613426: Effect of Very Early and Rapid Lowering Cholesterol With Evolocumab on Left Ventricular Remodeling in Patients With Anterior STEMI Undergoing Primary PCI
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: ST Elevation Myocardial Infarction (STEMI)
Keywords: ST Elevation Myocardial Infarction
percutaneous coronary intervention
PCSK9 Inhibitors
left ventricular remodeling
Lead sponsor: Henan Institute of Cardiovascular Epidemiology
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Change in left ventricular ejection fraction (LVEF)
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in left ventricular end diastolic/systolic diameter
timeFrame: Baseline and 12 weeks
measure: Change in left ventricular end diastolic/systolic volume
timeFrame: Baseline and 12 weeks
measure: A composite of cardiovascular death, recurrent myocardial infarction, ischemic stroke, and hospitalization for heart failure
timeFrame: 12 weeks, 52 weeks
measure: Proportion of LDL-C < 1.4 mmol/L
timeFrame: One week, 12 weeks
measure: Thrombolysis in Myocardial Infarction (TIMI) flow grade
timeFrame: TIMI flow in culprit coronary artery at first coronary angiography, and immediately after primary PCI within 12 hours of onset
measure: Level of troponin
timeFrame: 24 hours, 48 hours, and at hospital discharge, an average of 10 days after randomization
measure: Number of patients with adverse events and serious adverse events
timeFrame: At hospital discharge, an average of 10 days after randomization
Other outcomes:
Locations:
city: Gongyi
country: China
facility: The People's Hospital of Gongyi
state: Henan
city: Kaifeng
country: China
facility: Kaifeng Central Hospital
state: Henan
city: Xinxiang
country: China
facility: The People's Hospital of Changyuan
state: Henan
city: Xinzheng
country: China
facility: Hopeshine Minsheng Hospital of Xinzheng
state: Henan
city: Xuchang
country: China
facility: The People's Hospital of Xuchang
state: Henan
city: Zhengzhou
country: China
facility: Fuwai Central China Cardiovascular Hospital
state: Henan
Study officials:
References: