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Status unknownNCT04100434EMSIACSUpdated Nov 24, 2020

Effect of Evolocumab Added to Moderate-Intensity Statin Therapy on LDL-C Lowering and Cardiovascular Adverse Events in Patients With Acute Coronary Syndrome

A Phase 4 interventional study of Evolocumab in Acute Coronary Syndrome and Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor, sponsored by Tianjin Chest Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-24.

Sponsored by Tianjin Chest Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The study is an open-label, multicenter, and randomized study(five hospitals).The purpose of this study is to assess the differences in the effects of the evolocumab added to moderate-intensity statin therapy and the moderate-intensity statin only therapy on the regulation of LDL-C levels in patients with acute phase acute coronary syndrome after four weeks of treatment. The primary outcome is the percentage change in LDL-C in weeks 4 and week 12 after treatment. The secondary outcome is the occurrence of MACE after 12 weeks and 1 year of treatment.

02

Conditions studied

  • Acute Coronary Syndrome
  • Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor

Keywords

  • Acute Coronary Syndrome
  • Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor
  • Lipid-lowering Drug
  • Major Cardiovascular Adverse Events
03

In context

Acute Coronary Syndrome

1,488 studies on the registry are indexed under Acute Coronary Syndrome; 273 are open to participants now.

This study's planned enrollment of 500 is above the median of 200 across 865 interventional studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

Tianjin Chest Hospital is the lead sponsor of 9 studies on the registry; 4 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
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

  • Recent hospitalization for acute coronary syndrome: Complies with the diagnostic criteria for acute coronary syndrome (non-ST-segment elevation myocardial infarction, acute ST-segment elevation myocardial infarction, and unstable angina within 72 hours of onset)

  • LDL-C level (meet one of the following conditions):

    1. Prior to the study, patients who received intensive statins for more than 4 weeks (the same dose of statin therapy has been sustained for the past four weeks) with LDL-C levels ≥70 mg/dL (≥1.8 mmol/L) or non-HDL-C ≥100 mg /dL (≥2.6mmol/L) are included in the study;
    2. Prior to the study, patients who received moderate-intensity statin therapy for more than 4 weeks (the same dose of statin therapy has been sustained for the past four weeks) with LDL-C levels ≥90 mg/dL (≥2.3 mmol/L) or non-HDL-C≥ 120mg/dL (≥3.1mmol/L) are included in the study;
    3. Prior to the study, patients who do not receive statin therapy or who do not continue to receive statin with LDL-C ≥ 125 mg/dL (≥ 3.2 mmol/L) or non-HDL-C ≥ 155 mg/dL (≥ 4.0 mmol/L).
  • Being able to understand research requirements and sign

Exclusion criteria

Exclusion Criteria:

  • Unstable clinical status (hemodynamics or instability)
  • Uncontrolled arrhythmia, defined as recurrent or symptomatic ventricular tachycardia and atrial fibrillation with rapid ventricular reaction that the drug cannot control within three months prior to screening
  • Severe renal insufficiency, defined as estimated \<30ml/min/1.73m2
  • Active liver disease or liver dysfunction, whether it is on the patient's medical record or defined as an increase in or aspartate aminotransferase more than 3 times above the
  • Records on statin or rosuvastatin (any dose) intolerance or other statin intolerance
  • Known allergies to contrast agents, heparin, aspirin, ticagrelor or clopidogrel
  • Known allergies to the supplements required for the use of the drug
  • Patients who have been treated with evolocumab or other PCSK9 inhibitors
  • Received cholesterol ester transfer protein inhibitors treatment 12 months prior to screening
  • Received systemic or cyclosporine treatment in the past 3 months
  • Known infections, hemorrhages, metabolic or endocrine disorders as determined by the researchers
  • Patients who have been included in other studies
  • Patients with active malignant tumor in need of treatment
  • Women with fertility (age \<50 years, menstruation in the past 12 months), did not receive tubal ligation, oophorectomy or hysterectomy
Terms in these criteria, in plain language(6)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

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.

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.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
500 participants (estimated)

Study arms

  • Experimental
    the evolocumab plus statin therapy

    Patients with ACS are treated with atorvastatin (20mg) daily and evolocumab (140 mg) every two weeks throughout the study period

    Drug: Evolocumab

  • No intervention
    the statin alone therapy

    Patients with ACS are treated with atorvastatin (20mg) daily throughout the study period.

Interventions

  • DrugEvolocumab

    Patients were randomly assigned of the ratio of 1:1 using a computer-generated random number and divided into two treatment groups: the statin alone therapy and the evolocumab plus statin therapy.

06

What researchers measure

Primary outcomes

  1. Percent change in LDL-C

    Time frame: 4 weeks

Secondary outcomes

  1. Major cardiovascular adverse events

    Coronary heart disease death，nonfatal myocardial infarction，hospitalization for unstable angina，unplanned coronary revascularization, and stroke

    Time frame: 4 weeks and 1 year

Other outcomes

  1. The mean percentage change from baseline in LDL-C levels

    Time frame: within 1 year

  2. The proportion of patients with LDL-C <70 mg/dL during treatment

    Time frame: week 4 and week 12

  3. the quality of life of patients

    using EQ-5D-3L questionnaire score to assess the quality of life

    Time frame: week 12 and week 48

  4. The effect of evolocumab on platelet function based on the area under curve

    using Col/ADP test to evaluate platelet function

    Time frame: from baseline to 72 hours and baseline to week 4

  5. the effect of evolocumab on the percentage change of inflammatory markers (high-sensitivity C-reactive protein)

    Time frame: from baseline to week 48

07

Study locations

1 of 1 sites recruiting
  • Tianjin Chest Hospital,
    Tianjin, 300222, China
    Recruiting
08

References and documents

Publications

  • Gao J, Liu JY, Lu PJ, Xiao JY, Gao MD, Li CP, Cui Z, Liu Y. Effects of Evolocumab Added to Moderate-Intensity Statin Therapy in Chinese Patients With Acute Coronary Syndrome: The EMSIACS Trial Study Protocol. Front Physiol. 2021 Nov 23;12:750872. doi: 10.3389/fphys.2021.750872. eCollection 2021. PubMed 34887772 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2021; primary completion for Jun 2022, 17 months later.

Of 85 non-industry phase 4 interventional studies under Acute Coronary Syndrome, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 67. This study's planned 17 months is below that.

Counting every sponsor, half of 92 studies reached it within 42 months; a quarter within 26 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 21, 2019
First posted
Sep 24, 2019
StartEst.
Jan 1, 2021
Primary completionEst.
Jun 1, 2022
CompletionEst.
Jun 1, 2023
Last update
Nov 24, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04100434
Lead sponsor
Tianjin Chest Hospital
Responsible party
Yin Liu,MD (Director of coronary care unit, Tianjin Chest Hospital) — Principal investigator
First posted
Sep 24, 2019
Start date
Jan 1, 2021 (estimated)
Primary completion
Jun 1, 2022 (estimated)
Completion
Jun 1, 2023 (estimated)
Last update
Nov 24, 2020

Study contacts

Jing Gao, PHD
Contact
gaojing2088@163.com
+86-13820156072

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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