Acute Myocardial Infarction (AMI)NCT07208006
Very Early PCSK9 Inhibition for Acute Myocardial Infarction
A study testing Standard Lipid-Lowering Therapy and Early Intensive Lipid-Lowering Therapy (PCSK9 Inhibitor) in people with Acute Myocardial Infarction (AMI), run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Acute myocardial infarction (AMI) remains a major cause of morbidity and mortality, particularly in patients with multivessel coronary artery disease. Although primary percutaneous coronary intervention (PCI) has significantly improved short-term outcomes, these patients remain at high risk of recurrent cardiovascular… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Myocardial Infarction (AMI)
- What is being tested?
- Standard Lipid-Lowering Therapy and Early Intensive Lipid-Lowering Therapy (PCSK9 Inhibitor)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,518 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Acute myocardial infarction (AMI) onset within 30 days (first hospitalization with a confirmed diagnosis of STEMI or NSTEMI).
- Multivessel coronary artery disease; successful percutaneous coronary intervention (PCI) of the culprit lesion in the infarct-related artery (IRA), including stent implantation and/or balloon angioplasty and/or thrombus aspiration.
- At least one angiographically assessed diameter stenosis ≥50% in a non-infarct-related artery (non-IRA) with a reference vessel diameter ≥2.5 mm.
- Able to understand and willing to provide written informed consent, comply with prescribed medical therapy, and complete the required follow-up.
Who cannot join
- Cardiogenic shock or severe heart failure (Killip class IV).
- Serum creatinine >150 μmol/L or glomerular filtration rate (GFR) <45 mL/min/1.73 m² calculated by the Cockcroft-Gault equation.
- Known or suspected infective endocarditis or active systemic infection.
- Clinically significant coagulation abnormalities, or anticipated inability to tolerate long-term antiplatelet therapy.
- Pregnant or breastfeeding women, women planning pregnancy within 1 year, or those unwilling to use effective contraception.
- Expected survival <1 year.
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- Allergy to iodinated contrast media.
- Prior coronary artery bypass grafting (CABG).
- Participation in another clinical trial within 3 months before enrollment, or current participation in another drug/device clinical trial without having reached its primary endpoint.
- Coronary angiography-based exclusion criteria:
- 10.1 Non-IRA lesion with visually estimated diameter stenosis >90% and TIMI flow ≤2; 10.2 Complex coronary artery disease requiring CABG; 10.3 Angiography unable to clearly identify the infarct-related artery or non-infarct-related arteries.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
gao wei, 13661959824, gao.wei1@zs-hospital.sh.cn
About this study
Official title: Impact of PCSK9 Monoclonal Antibody Very Early Administered in Hospital to Reduce Cardiovascular Events in Acute Myocardial Infarction (IMMEDIATE -MI)
Acute myocardial infarction (AMI) remains a major cause of morbidity and mortality, particularly in patients with multivessel coronary artery disease. Although primary percutaneous coronary intervention (PCI) has significantly improved short-term outcomes, these patients remain at high risk of recurrent cardiovascular events due to vulnerable non-culprit plaques. Coronary imaging techniques such as intravascular ultrasound (IVUS), optical coherence tomography (OCT), and angiography-derived indices (QFR, RWS) can identify high-risk lesions, but the optimal management strategy is still debated.
Early and intensive lipid-lowering therapy has been shown to stabilize atherosclerotic plaques. PCSK9 monoclonal antibodies, in combination with statins, provide rapid and profound LDL-cholesterol reduction and may enhance plaque stabilization beyond standard therapy. Small imaging studies suggest favorable effects of PCSK9 inhibitors on fibrous cap thickness and lipid burden, but their impact on clinical outcomes in AMI patients with multivessel disease remains uncertain.
This study aims to evaluate whether very early in-hospital administration of a PCSK9 inhibitor, in addition to standard care, can reduce major adverse cardiovascular events (MACE) over 12 months compared with standard lipid-lowering therapy alone. The trial will also explore imaging-based markers of plaque vulnerability and functional indices as secondary endpoints, in order to better understand the mechanisms linking lipid lowering, plaque stabilization, and clinical outcomes.
- Conditions
- Acute Myocardial Infarction (AMI)
- Being tested
- Standard Lipid-Lowering Therapy, Early Intensive Lipid-Lowering Therapy (PCSK9 Inhibitor)
- Keywords
- Acute Myocardial Infarction; Multivessel Disease; PCSK9 Inhibitor; Lipid-Lowering Therapy; Plaque Vulnerability; MACE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Lipid-Lowering TherapyDrug
Participants will receive lipid-lowering therapy according to current clinical guidelines. Treatment will be initiated with statins. Based on follow-up lipid levels, ezetimibe may be added, and PCSK9 inhibitor therapy may be considered if LDL-C goals are not met.
Early Intensive Lipid-Lowering Therapy (PCSK9 Inhibitor)Drug
Participants will receive early intensive lipid-lowering therapy with a PCSK9 monoclonal antibody, initiated during the index hospitalization, in addition to statins. Ezetimibe may be added if clinically indicated. The PCSK9 inhibitor will be administered regardless of baseline lipid levels.
| Study group | Role | What they receive |
|---|---|---|
| Standard Lipid-Lowering Therapy | Active comparator | Participants will receive guideline-recommended lipid-lowering therapy starting with statins. Based on follow-up lipid levels, additional agents such as ezetimibe and PCSK9 inhibitors may be added sequentially, according to routine clinical practice. Receives: Drug: Standard Lipid-Lowering Therapy |
| Early Intensive Lipid-Lowering Therapy (PCSK9 Inhibitor) | Experimental | Participants will receive early intensive lipid-lowering therapy with a PCSK9 monoclonal antibody initiated during index hospitalization, in addition to statins. Ezetimibe may be added as needed. The PCSK9 inhibitor will be given regardless of baseline lipid levels. Receives: Drug: Early Intensive Lipid-Lowering Therapy (PCSK9 Inhibitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Major Adverse Cardiovascular Events (MACE) at 12 Months
MACE is defined as a composite endpoint including all-cause death, non-fatal myocardial infarction, stroke, unplanned ischemia-driven revascularization, and rehospitalization for unstable angina. The occurrence of the first event from this composite will be recorded for each participant.
Measured: 12 months after index percutaneous coronary intervention (±30 days)
Secondary outcomes (6)
Incidence of Key Secondary Cardiovascular Events
Composite of cardiovascular death, non-fatal myocardial infarction, stroke, and unplanned ischemia-driven revascularization.
Measured: 12 months after index PCI (±30 days)
Incidence of All-Cause Death
Death from cardiovascular causes, non-cardiovascular causes, or unknown causes.
Measured: 12 months after index PCI (±30 days)
Incidence of Non-fatal Myocardial Infarction
Defined according to SCAI criteria for peri-procedural MI and spontaneous MI related to culprit or non-culprit vessels.
Measured: 12 months after index PCI (±30 days)
Incidence of Non-fatal Ischemic Stroke
Stroke confirmed by clinical diagnosis and imaging, excluding hemorrhagic stroke.
Measured: 12 months after index PCI (±30 days)
Incidence of Unplanned Ischemia-Driven Revascularization
Repeat PCI or CABG driven by ischemic symptoms or objective evidence of ischemia, involving culprit or non-culprit vessels.
Measured: 12 months after index PCI (±30 days)
Rehospitalization for Unstable Angina
Hospital admission due to recurrent chest pain confirmed as unstable angina requiring medical management.
Measured: 12 months after index PCI (±30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start1 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial Infarction (AMI)Studies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- 1,518 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208006
- Sponsor's protocol ID
- KY2025169
- Status last verified
- Sep 2025
- First submitted
- 27 Sep 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of PCSK9 Monoclonal Antibody Very Early Administered in Hospital to Reduce Cardiovascular Events in Acute Myocardial Infarction (IMMEDIATE -MI)
- ClinicalTrials.gov ID
- NCT07208006
- Acronym / sponsor ID
- KY2025169
- Conditions
- Acute Myocardial Infarction (AMI)
- Keywords
- Acute Myocardial Infarction; Multivessel Disease; PCSK9 Inhibitor; Lipid-Lowering Therapy; Plaque Vulnerability; MACE
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,518 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 6 Oct 2025 (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 myocardial infarction (AMI) remains a major cause of morbidity and mortality, particularly in patients with multivessel coronary artery disease. Although primary percutaneous coronary intervention (PCI) has significantly improved short-term outcomes, these patients remain at high risk of recurrent cardiovascular events due to vulnerable non-culprit plaques. Coronary imaging techniques such as intravascular ultrasound (IVUS), optical coherence tomography (OCT), and angiography-derived indices (QFR, RWS) can identify high-risk lesions, but the optimal management strategy is still debated.
Early and intensive lipid-lowering therapy has been shown to stabilize atherosclerotic plaques. PCSK9 monoclonal antibodies, in combination with statins, provide rapid and profound LDL-cholesterol reduction and may enhance plaque stabilization beyond standard therapy. Small imaging studies suggest favorable effects of PCSK9 inhibitors on fibrous cap thickness and lipid burden, but their impact on clinical outcomes in AMI patients with multivessel disease remains uncertain.
This study aims to evaluate whether very early in-hospital administration of a PCSK9 inhibitor, in addition to standard care, can reduce major adverse cardiovascular events (MACE) over 12 months compared with standard lipid-lowering therapy alone. The trial will also explore imaging-based markers of plaque vulnerability and functional indices as secondary endpoints, in order to better understand the mechanisms linking lipid lowering, plaque stabilization, and clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Lipid-Lowering Therapy | Active comparator | Drug: Standard Lipid-Lowering TherapyParticipants will receive guideline-recommended lipid-lowering therapy starting with statins. Based on follow-up lipid levels, additional agents such as ezetimibe and PCSK9 inhibitors may be added sequentially, according to routine clinical practice. |
| Early Intensive Lipid-Lowering Therapy (PCSK9 Inhibitor) | Experimental | Drug: Early Intensive Lipid-Lowering Therapy (PCSK9 Inhibitor)Participants will receive early intensive lipid-lowering therapy with a PCSK9 monoclonal antibody initiated during index hospitalization, in addition to statins. Ezetimibe may be added as needed. The PCSK9 inhibitor will be given regardless of baseline lipid levels. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years.
- Acute myocardial infarction (AMI) onset within 30 days (first hospitalization with a confirmed diagnosis of STEMI or NSTEMI).
- Multivessel coronary artery disease; successful percutaneous coronary intervention (PCI) of the culprit lesion in the infarct-related artery (IRA), including stent implantation and/or balloon angioplasty and/or thrombus aspiration.
- At least one angiographically assessed diameter stenosis ≥50% in a non-infarct-related artery (non-IRA) with a reference vessel diameter ≥2.5 mm.
- Able to understand and willing to provide written informed consent, comply with prescribed medical therapy, and complete the required follow-up.
Key exclusion criteria (11 listed)
- Cardiogenic shock or severe heart failure (Killip class IV).
- Serum creatinine >150 μmol/L or glomerular filtration rate (GFR) <45 mL/min/1.73 m² calculated by the Cockcroft-Gault equation.
- Known or suspected infective endocarditis or active systemic infection.
- Clinically significant coagulation abnormalities, or anticipated inability to tolerate long-term antiplatelet therapy.
- Pregnant or breastfeeding women, women planning pregnancy within 1 year, or those unwilling to use effective contraception.
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 |
|---|---|---|
| Standard Lipid-Lowering TherapyParticipants will receive lipid-lowering therapy according to current clinical guidelines. Treatment will be initiated with statins. Based on follow-up lipid levels, ezetimibe may be added, and PCSK9 inhibitor therapy may be considered if LDL-C goals are not met. | Drug | Standard Lipid-Lowering Therapy |
| Early Intensive Lipid-Lowering Therapy (PCSK9 Inhibitor)Participants will receive early intensive lipid-lowering therapy with a PCSK9 monoclonal antibody, initiated during the index hospitalization, in addition to statins. Ezetimibe may be added if clinically indicated. The PCSK9 inhibitor will be administered regardless of baseline lipid levels. | Drug | Early Intensive Lipid-Lowering Therapy (PCSK9 Inhibitor) |
Primary outcome
Incidence of Major Adverse Cardiovascular Events (MACE) at 12 Months
Time frame: 12 months after index percutaneous coronary intervention (±30 days)
MACE is defined as a composite endpoint including all-cause death, non-fatal myocardial infarction, stroke, unplanned ischemia-driven revascularization, and rehospitalization for unstable angina. The occurrence of the first event from this composite will be recorded for each participant.
6 secondary outcomes
Incidence of Key Secondary Cardiovascular Events
Time frame: 12 months after index PCI (±30 days)
Incidence of All-Cause Death
Time frame: 12 months after index PCI (±30 days)
Incidence of Non-fatal Myocardial Infarction
Time frame: 12 months after index PCI (±30 days)
Incidence of Non-fatal Ischemic Stroke
Time frame: 12 months after index PCI (±30 days)
Incidence of Unplanned Ischemia-Driven Revascularization
Time frame: 12 months after index PCI (±30 days)
Rehospitalization for Unstable Angina
Time frame: 12 months after index PCI (±30 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Lipid-Lowering Therapy and Early Intensive Lipid-Lowering Therapy (PCSK9 Inhibitor) in people with Acute Myocardial Infarction (AMI), run by Shanghai Zhongshan 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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 27 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Gao, PhD (+8613661959824, gao.wei1@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Major Adverse Cardiovascular Events (MACE) at 12 Months (time frame: 12 months after index percutaneous coronary intervention (±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 27 Jan 2026.