ST Elevation Myocardial Infarction (STEMI)Phase 4EVALUATE-STEMINCT05613426
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 study testing Rosuvastatin 20 mg and Evolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA] in people with ST Elevation Myocardial Infarction (STEMI), run by Henan Institute of Cardiovascular Epidemiology at 6 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ST Elevation Myocardial Infarction (STEMI)
- What is being tested?
- Rosuvastatin 20 mg and Evolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 6 sitesChina
- Study dates
- 3 Apr 2023to 16 May 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
The People's Hospital of Gongyi
Gongyi, Henan
Kaifeng Central Hospital
Kaifeng, Henan
The People's Hospital of Changyuan
Xinxiang, Henan
Hopeshine Minsheng Hospital of Xinzheng
Xinzheng, Henan
The People's Hospital of Xuchang
Xuchang, Henan
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan
About this study
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
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.
- Being tested
- Rosuvastatin 20 mg, Evolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA]
- Keywords
- ST Elevation Myocardial Infarction, percutaneous coronary intervention, PCSK9 Inhibitors, left ventricular remodeling
- Medical subject headings
- ST Elevation Myocardial Infarction, Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin 20 mgDrug
Very early use of Rosuvastatin before primary PCI in anterior STEMI
Evolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA]Drug
Very early use of Evolocumab before primary PCI in anterior STEMI
| Study group | Role | What they receive |
|---|---|---|
| Intensive statin group | Active comparator | Rosuvastatin, 20 mg per day after randomization Receives: 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 Receives: 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 Receives: Drug: Evolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in left ventricular ejection fraction (LVEF)
Echocardiography Core Laboratory, blinded analysis
Measured: Baseline and 12 weeks
Secondary outcomes (7)
Change in left ventricular end diastolic/systolic diameter
Echocardiography Core Laboratory, blinded analysis
Measured: Baseline and 12 weeks
Change in left ventricular end diastolic/systolic volume
Echocardiography Core Laboratory, blinded analysis
Measured: Baseline and 12 weeks
A composite of cardiovascular death, recurrent myocardial infarction, ischemic stroke, and hospitalization for heart failure
Measured: 12 weeks, 52 weeks
Proportion of LDL-C < 1.4 mmol/L
Measured: One week, 12 weeks
Thrombolysis in Myocardial Infarction (TIMI) flow grade
Measured: TIMI flow in culprit coronary artery at first coronary angiography, and immediately after primary PCI within 12 hours of onset
Level of troponin
Measured: 24 hours, 48 hours, and at hospital discharge, an average of 10 days after randomization
Number of patients with adverse events and serious adverse events
Measured: At hospital discharge, an average of 10 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start3 Apr 2023
- Primary completion16 Jul 2025
- Study completion16 May 2026
Why it stopped: Slow patient enrollment and lack of financial support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation Myocardial Infarction (STEMI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan Institute of Cardiovascular Epidemiology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chuanyu Gao, Henan Institute of Cardiovascular Epidemiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613426
- Sponsor's protocol ID
- HenanICE202204
- Acronym
- EVALUATE-STEMI
- Status last verified
- May 2026
- First submitted
- 18 Oct 2022
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05613426
- Acronym / sponsor ID
- EVALUATE-STEMI / HenanICE202204
- Keywords
- ST Elevation Myocardial Infarction, percutaneous coronary intervention, PCSK9 Inhibitors, left ventricular remodeling
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow patient enrollment and lack of financial support
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Henan Institute of Cardiovascular EpidemiologyUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 16 Jul 2025 (actual)
- Study completion
- 16 May 2026 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intensive statin group | Active comparator | Drug: Rosuvastatin 20 mgRosuvastatin, 20 mg per day after randomization |
| Combined intensive statin and PCSK9 inhibitor group | Experimental | Drug: Rosuvastatin 20 mg, Drug: Evolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA]Evolocumab, 140 mg twice a month after randomization, and Rosuvastatin, 20 mg per day after randomization |
| PCSK9 inhibitor alone group | Experimental | Drug: Evolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA]Evolocumab, 140 mg twice a month after randomization |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosuvastatin 20 mgVery early use of Rosuvastatin before primary PCI in anterior STEMI | Drug | Combined intensive statin and PCSK9 inhibitor group, Intensive statin group |
| Evolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA]Very early use of Evolocumab before primary PCI in anterior STEMI | Drug | Combined intensive statin and PCSK9 inhibitor group, PCSK9 inhibitor alone group |
Primary outcome
Change in left ventricular ejection fraction (LVEF)
Time frame: Baseline and 12 weeks
Echocardiography Core Laboratory, blinded analysis
7 secondary outcomes
Change in left ventricular end diastolic/systolic diameter
Time frame: Baseline and 12 weeks
Change in left ventricular end diastolic/systolic volume
Time frame: Baseline and 12 weeks
A composite of cardiovascular death, recurrent myocardial infarction, ischemic stroke, and hospitalization for heart failure
Time frame: 12 weeks, 52 weeks
Proportion of LDL-C < 1.4 mmol/L
Time frame: One week, 12 weeks
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
Level of troponin
Time frame: 24 hours, 48 hours, and at hospital discharge, an average of 10 days after randomization
Number of patients with adverse events and serious adverse events
Time frame: At hospital discharge, an average of 10 days after randomization
Results and safety
The study was stopped early (reason given: Slow patient enrollment and lack of financial support). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin 20 mg and Evolocumab 140 mg/1 ml Subcutaneous Solution [REPATHA] in people with ST Elevation Myocardial Infarction (STEMI), run by Henan Institute of Cardiovascular Epidemiology at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow patient enrollment and lack of financial support). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in left ventricular ejection fraction (LVEF) (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.