ClinicalTrials.gg
TerminatedNCT05613426EVALUATE-STEMIUpdated May 22, 2026

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

A Phase 4 interventional study of Rosuvastatin 20 mg and Evolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA] in ST Elevation Myocardial Infarction (STEMI), sponsored by Henan Institute of Cardiovascular Epidemiology. Terminated at 6 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Henan Institute of Cardiovascular Epidemiology · Phase 4, Interventional, and Treatment

Why this study was terminated
Slow patient enrollment and lack of financial support
Phase
Phase 4
Study type
Interventional
Enrollment
119
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • ST Elevation Myocardial Infarction (STEMI)

Keywords

  • ST Elevation Myocardial Infarction
  • percutaneous coronary intervention
  • PCSK9 Inhibitors
  • left ventricular remodeling
03

In context

ST Elevation Myocardial Infarction

850 studies on the registry are indexed under ST Elevation Myocardial Infarction; 197 are open to participants now.

This study's enrollment of 119 is below the median of 194 across 527 interventional studies indexed under ST Elevation Myocardial Infarction.

Browse ST Elevation Myocardial Infarction studies →

Lead sponsor

Henan Institute of Cardiovascular Epidemiology is the lead sponsor of 31 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • 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 ( ≥5 ; estimated \<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 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
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
119 participants (actual)

Study arms

  • Active comparator
    Intensive statin group

    Rosuvastatin, 20 mg per day after randomization

    Drug: Rosuvastatin 20 mg

  • Experimental
    Combined intensive statin and PCSK9 inhibitor group

    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]

  • Experimental
    PCSK9 inhibitor alone group

    Evolocumab, 140 mg twice a month after randomization

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

Interventions

  • Very early use of Rosuvastatin before primary PCI in anterior STEMI

  • DrugEvolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA]

    Drug page: Evolocumab

    Very early use of Evolocumab before primary PCI in anterior STEMI

06

What researchers measure

Primary outcomes

  1. Change in left ventricular ejection fraction (LVEF)

    Echocardiography Core Laboratory, blinded analysis

    Time frame: Baseline and 12 weeks

Secondary outcomes

  1. Change in left ventricular end diastolic/systolic diameter

    Echocardiography Core Laboratory, blinded analysis

    Time frame: Baseline and 12 weeks

  2. Change in left ventricular end diastolic/systolic volume

    Echocardiography Core Laboratory, blinded analysis

    Time frame: Baseline and 12 weeks

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

    Time frame: 12 weeks, 52 weeks

  4. Proportion of LDL-C < 1.4 mmol/L

    Time frame: One week, 12 weeks

  5. Thrombolysis in Myocardial Infarction (TIMI) flow grade

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

  6. Level of troponin

    Time frame: 24 hours, 48 hours, and at hospital discharge, an average of 10 days after randomization

  7. Number of patients with adverse events and serious adverse events

    Time frame: At hospital discharge, an average of 10 days after randomization

07

Study locations

6 sites
  • The People's Hospital of Gongyi
    Gongyi, Henan, China
  • Kaifeng Central Hospital
    Kaifeng, Henan, China
  • The People's Hospital of Changyuan
    Xinxiang, Henan, China
  • Hopeshine Minsheng Hospital of Xinzheng
    Xinzheng, Henan, China
  • The People's Hospital of Xuchang
    Xuchang, Henan, China
  • Fuwai Central China Cardiovascular Hospital
    Zhengzhou, Henan, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05613426
Lead sponsor
Henan Institute of Cardiovascular Epidemiology
Responsible party
Chuanyu Gao (Vice President, Chief of Cardiology Department, Henan Institute of Cardiovascular Epidemiology) — Principal investigator
First posted
Nov 14, 2022
Start date
Apr 3, 2023
Primary completion
Jul 16, 2025
Completion
May 16, 2026
Last update
May 22, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Rosuvastatin · Evolocumab

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