STEMINCT06364124
Effects of PCSK-9 Inhibitor Treatment Prior to Undergoing Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction
A study testing evolocumab and standard post-treatment for STEMI in people with STEMI, run by Beijing Luhe Hospital at 1 site in China.
Trial summary
Acute ST-segment elevation myocardial infarction (STEMI) is a common manifestation of cardiovascular emergencies. Percutaneous coronary intervention (PCI) and guideline-recommended pharmacotherapy have reduced mortality rates associated with STEMI, but the incidence of recurrent ischemic events, particularly early… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- STEMI
- What is being tested?
- evolocumab and standard post-treatment for STEMI
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 1 Jun 2025
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients are selected from the Cardiology Department of Beijing Luhe Hospital and have undergone direct PCI treatment for STEMI.
- STEMI patients must meet the following criteria:
- Chest pain duration ≥ 30 minutes, with ST-segment elevation ≥ 0.1 mV in adjacent two leads on the electrocardiogram.
- Onset within 24 hours.
- Aged between 18 and 80 years.
- Signed informed consent form.
Who cannot join
- Hemodynamically unstable or Killip grade ≥ 2.
- Severe renal insufficiency: Glomerular filtration rate < 30 ml/min/1.73m^2.
- Active liver disease or liver dysfunction: AST or ALT levels > 3 times the upper limit of normal.
- Known allergy to any drug used in the study.
- Previous or planned use of PCSK9 inhibitors.
- Suspected stress cardiomyopathy or acute pericarditis.
- Malignant tumors requiring treatment or other severe systemic diseases.
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing luhe hospital
Beijing
rui yan, 17746570262, yanrui4112@163.com
About this study
Official title: Effects of PCSK-9 Inhibitor Treatment Prior to Undergoing Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction: A Single-center，Randomized,Open-label Trial
Acute ST-segment elevation myocardial infarction (STEMI) is a common manifestation of cardiovascular emergencies. Percutaneous coronary intervention (PCI) and guideline-recommended pharmacotherapy have reduced mortality rates associated with STEMI, but the incidence of recurrent ischemic events, particularly early ischemic events, remains high. Current research suggests that low-density lipoprotein cholesterol (LDL-C) levels not meeting guideline-recommended levels and inflammation are closely related to early recurrent ischemic events. Evolocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, rapidly and effectively reduces LDL-C levels and suppresses inflammation. Long-term use in patients with acute coronary syndromes can reverse atherosclerosis and improve prognosis. However, data on its use in STEMI patients are limited, particularly regarding the cardioprotective effects of preoperative administration of 420mg evolocumab subcutaneous injection. This study aims to evaluate the effects of administering evolocumab 420mg before emergency PCI on lipid profiles, inflammatory markers, myocardial injury, and short-term prognosis in STEMI patients through a single-center, randomized, open-label study. It aims to provide theoretical evidence for further reducing the risk of recurrent cardiovascular events in STEMI and identifying more optimized treatment strategies.
- Conditions
- STEMI
- Being tested
- evolocumab, standard post-treatment for STEMI
- Keywords
- evolocumab, STEMI, LDL-C
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evolocumabDrug
Also called repatha
Preoperative subcutaneous injection of Evolocumab (420mg)，Atorvastatin 40mg per day
standard post-treatment for STEMIProcedure or surgery
standard post-treatment for STEMI
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm: standard post-treatment for STEMI and Evolocumab | Experimental | The intervention group will receive a preoperative subcutaneous injection of Evolocumab (420mg) and standard post-treatment for STEMI Receives: Drug: evolocumab; Procedure: standard post-treatment for STEMI |
| Control arm: standard post-treatment for STEMI | Active comparator | Standard post-treatment for STEMI Receives: Procedure: standard post-treatment for STEMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average percent change from baseline in LDL-C levels to discharge and day 30
Measured: 30 days
Secondary outcomes (3)
Average percent change from baseline in total cholesterol, high-density lipoprotein cholesterol, triglycerides, apolipoprotein A and apolipoprotein B to discharge and day 30
Measured: 30 days
Average percent change from baseline in MMP-9, CSF-1, IL-18R1 to discharge and day 30
Measured: 30 days
Number of cardiovascular events to day 30
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start1 Jun 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMIStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Luhe Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jincheng Guo, Beijing Luhe Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364124
- Sponsor's protocol ID
- MR-11-23-035852
- Status last verified
- May 2024
- First submitted
- 1 Apr 2024
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of PCSK-9 Inhibitor Treatment Prior to Undergoing Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction: A Single-center，Randomized,Open-label Trial
- ClinicalTrials.gov ID
- NCT06364124
- Acronym / sponsor ID
- MR-11-23-035852
- Conditions
- STEMI
- Keywords
- evolocumab, STEMI, LDL-C
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Beijing Luhe HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 15 Apr 2024 (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.
Acute ST-segment elevation myocardial infarction (STEMI) is a common manifestation of cardiovascular emergencies. Percutaneous coronary intervention (PCI) and guideline-recommended pharmacotherapy have reduced mortality rates associated with STEMI, but the incidence of recurrent ischemic events, particularly early ischemic events, remains high. Current research suggests that low-density lipoprotein cholesterol (LDL-C) levels not meeting guideline-recommended levels and inflammation are closely related to early recurrent ischemic events. Evolocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, rapidly and effectively reduces LDL-C levels and suppresses inflammation. Long-term use in patients with acute coronary syndromes can reverse atherosclerosis and improve prognosis. However, data on its use in STEMI patients are limited, particularly regarding the cardioprotective effects of preoperative administration of 420mg evolocumab subcutaneous injection. This study aims to evaluate the effects of administering evolocumab 420mg before emergency PCI on lipid profiles, inflammatory markers, myocardial injury, and short-term prognosis in STEMI patients through a single-center, randomized, open-label study. It aims to provide theoretical evidence for further reducing the risk of recurrent cardiovascular events in STEMI and identifying more optimized treatment strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm: standard post-treatment for STEMI and Evolocumab | Experimental | Drug: evolocumab, Procedure: standard post-treatment for STEMIThe intervention group will receive a preoperative subcutaneous injection of Evolocumab (420mg) and standard post-treatment for STEMI |
| Control arm: standard post-treatment for STEMI | Active comparator | Procedure: standard post-treatment for STEMIStandard post-treatment for STEMI |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All patients are selected from the Cardiology Department of Beijing Luhe Hospital and have undergone direct PCI treatment for STEMI.
- STEMI patients must meet the following criteria:
Key exclusion criteria (8 listed)
- Hemodynamically unstable or Killip grade ≥ 2.
- Severe renal insufficiency: Glomerular filtration rate < 30 ml/min/1.73m^2.
- Active liver disease or liver dysfunction: AST or ALT levels > 3 times the upper limit of normal.
- Known allergy to any drug used in the study.
- Previous or planned use of PCSK9 inhibitors.
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 |
|---|---|---|
| evolocumabAlso: repathaPreoperative subcutaneous injection of Evolocumab (420mg)，Atorvastatin 40mg per day | Drug | Treatment arm: standard post-treatment for STEMI and Evolocumab |
| standard post-treatment for STEMIstandard post-treatment for STEMI | Procedure or surgery | Control arm: standard post-treatment for STEMI, Treatment arm: standard post-treatment for STEMI and Evolocumab |
Primary outcome
Average percent change from baseline in LDL-C levels to discharge and day 30
Time frame: 30 days
3 secondary outcomes
Average percent change from baseline in total cholesterol, high-density lipoprotein cholesterol, triglycerides, apolipoprotein A and apolipoprotein B to discharge and day 30
Time frame: 30 days
Average percent change from baseline in MMP-9, CSF-1, IL-18R1 to discharge and day 30
Time frame: 30 days
Number of cardiovascular events to day 30
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing evolocumab and standard post-treatment for STEMI in people with STEMI, run by Beijing Luhe Hospital at 1 site 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact rui yan (17746570262, yanrui4112@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average percent change from baseline in LDL-C levels to discharge and day 30 (time frame: 30 days). 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 2024.