Effect of Very Early and Rapid Lowering Cholesterol With Evolocumab on Left Ventricular Remodeling in Patients With Anterior STEMI Undergoing Primary PCI

NCT05613426 | Recruiting Phase 4 DMC

• 1 other identifier: HenanICE202204
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 6

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.

Conditions

ST Elevation Myocardial Infarction (STEMI)

Keywords

ST Elevation Myocardial Infarction; percutaneous coronary intervention; PCSK9 Inhibitors; left ventricular remodeling

Outcome Measures

Primary Outcomes (1)

• Change in left ventricular ejection fraction (LVEF)

  Echocardiography Core Laboratory, blinded analysis

  Baseline and 12 weeks

Secondary Outcomes (7)

• Change in left ventricular end diastolic/systolic diameter

  Baseline and 12 weeks

• Change in left ventricular end diastolic/systolic volume

  Baseline and 12 weeks

• A composite of cardiovascular death, recurrent myocardial infarction, ischemic stroke, and hospitalization for heart failure

  12 weeks, 52 weeks

• Proportion of LDL-C < 1.4 mmol/L

  One week, 12 weeks

• Thrombolysis in Myocardial Infarction (TIMI) flow grade

  TIMI flow in culprit coronary artery at first coronary angiography, and immediately after primary PCI within 12 hours of onset

Study Arms (3)

Intensive statin group

ACTIVE COMPARATOR

Rosuvastatin, 20 mg per day after randomization

Drug: Rosuvastatin 20 mg

Combined intensive statin and PCSK9 inhibitor group

EXPERIMENTAL

Evolocumab, 140 mg twice a month after randomization, and Rosuvastatin, 20 mg per day after randomization

Drug: Rosuvastatin 20 mg; Drug: Evolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA]

PCSK9 inhibitor alone group

EXPERIMENTAL

Evolocumab, 140 mg twice a month after randomization

Drug: Evolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA]

Interventions

Rosuvastatin 20 mg DRUG

Very early use of Rosuvastatin before primary PCI in anterior STEMI

Combined intensive statin and PCSK9 inhibitor group; Intensive statin group

Evolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA] DRUG

Very early use of Evolocumab before primary PCI in anterior STEMI

Combined intensive statin and PCSK9 inhibitor group; PCSK9 inhibitor alone group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henan Institute of Cardiovascular Epidemiology: lead

Study Sites (6)

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

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Ventricular Remodeling

Interventions

Rosuvastatin Calcium; evolocumab

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

You Zhang, Doctor

CONTACT

+86 37158681037; youzhangww@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President, Chief of Cardiology Department

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: November 14, 2022
• Study Start: April 3, 2023
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

CN (6)