Acute Myocardial Infarction (AMI)Phase 4IMPROVE-AMINCT06683131
Effectiveness of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibitor Initiation Before Percutaneous Coronary Intervention on Acute Myocardial Infarction Patients
A Phase 4 study testing Tafolecimab in people with Acute Myocardial Infarction (AMI), run by The Affiliated Hospital of Xuzhou Medical University at 13 sites in China.
Trial summary
The goal of this clinical trial is to learn if drug tafolecimab works to treat participants with acute myocardial infarction (AMI) scheduled for primary percutaneous coronary intervention (PCI). It will also learn about the safety of drug tafolecimab. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myocardial Infarction (AMI)
- What is being tested?
- Tafolecimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,160 participants
- Where
- 13 sitesChina
- Study dates
- 20 Nov 2025to 30 Nov 2027
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18-75 years old
- AMI diagnosed according to the latest guidelines, including ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI)
- The requirement for STEMI was that primary PCI was scheduled within 12 hours of onset.
- The requirement for NSTEMI was that coronary angiography was scheduled within 2 hours for very high-risk participants and within 24 hours for high-risk participants .
- Regardless of baseline LDL-C levels
- Participants voluntarily took part in this study and signed informed consent
Who cannot join
- Previous or ongoing treatment for any PCSK9i
- Allergy to PCSK9i, statins, or any of the drug ingredients used during the trial
- History of hemorrhagic cerebrovascular disease
- History of old myocardial infarction/chronic heart failure
- History of PCI or coronary artery bypass grafting (CABG) or preparation for CABG
- Above Killip level II
Show all 12Show fewer
- Prolonged cardiopulmonary resuscitation (>20min)
- Definite mechanical complications (including perforation of the interventricular septum, or rupture of the papillary tendon bundle or the left ventricular free wall)
- malignant arrhythmia
- Severe uncontrolled infection, bleeding disorder, end-stage renal disease, severe liver disease, endocrine dysfunction, or the expected less than 1 year survival of malignant tumors
- Pregnant or lactating women
- Participate in other clinical trials
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
China13 sites
Peking University First Hospital
Beijing, 100000
Bo Zheng, PhD
Taihe County People's Hospital
Fuyang, Anhui
Xiaohong Bo
The Fifth People's Hospital of Huai'an City
Huai'an, Jiangsu
Linghui Zhao, PhD
Lianyungang Municipal Dongfang Hospital
Lianyungang, Jiangsu
Yecheng Lu
Jiangsu Provincial Hospital of Traditional Chinese Medicine
Nanjing, Jiangsu
Jiandong Chen, PhD
Jiangsu Provincial People's Hospital (The First Affiliated Hospital of Nanjing Medical University)
Nanjing, Jiangsu
Liansheng Wang, PhD
The Fourth Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
Chunlei Qi
Shanghai Tenth People's Hospital
Shanghai
Wenhui Peng, PhD
Suqian Hospital of Jiangsu Provincial People's Hospital
Suqian, Jiangsu
Zhiyong Zhang, PhD
The affiliated hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221006
Yuan Lu, +8613952110901, drluyuan329@163.com
Yiwen Wang, +8615094343962, wangyiwen@xzhmu.edu.cn
Suining County People's Hospital
Xuzhou, Jiangsu
Ruili Wang
Xuzhou Central Hospital
Xuzhou, Jiangsu
Bing Han, PhD
Xuzhou Mining Group General Hospital
Xuzhou, Jiangsu
Chunmei Qi, PhD
About this study
Official title: IMpact of PCSK9 inhibitoR initiatiOn Before Percutaneous Coronary Intervention on Coronary microVascular Dysfunction and Events for Acute Myocardial Infarction: a Multi-center, Open-label, Randomized, Controlled Trial
The goal of this clinical trial is to learn if drug tafolecimab works to treat participants with acute myocardial infarction (AMI) scheduled for primary percutaneous coronary intervention (PCI). It will also learn about the safety of drug tafolecimab. The main questions it aims to answer are:
- Does drug tafolecimab lower the risk of 1-year major adverse cardiovascular events?
- Does drug tafolecimab improve the coronary microvascular dysfunction?
- What medical problems do participants have when administering drug tafolecimab by injection? Researchers will compare the results administering drug tafolecimab or not to see if drug tafolecimab works to treat AMI.
Read more
Participants will:
- Administer drug tafolecimab by injection or not every month for 12 months
- Receive the standard of care of AMI
- Complete the measurement of coronary angiography-derived microcirculation resistance index after PCI
- Complete cardiac magnetic resonance after PCI if available
- Visit the clinic at 1,6,12 months after the first administration for checkups and tests
- Report any discomfort, event or queries at any time
- Conditions
- Acute Myocardial Infarction (AMI)
- Being tested
- Tafolecimab
- Keywords
- Acute Myocardial Infarction, tafolecimab, PCSK9, Coronary Microvascular Dysfunction, Major adverse cardiovascular events, monoclonal antibody against proprotein convertase subtilisin/kexin type 9, LDL-C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TafolecimabDrug
450mg of tafolecimab (150mg each one) was injected subcutaneously before primary PCI and then 150mg subcutaneously injected every half a month till totally 12 months.
| Study group | Role | What they receive |
|---|---|---|
| PCSK9 inhibitor (PCSK9i) group | Experimental | Participants receive PCSK9i tafolecimab and standard of care (SoC) of acute myocardial infarction Receives: Drug: Tafolecimab |
| Control group | No intervention | Participants receive SoC of acute myocardial infarction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of major adverse cardiovascular events (MACEs)
MACEs including cardiovascular death, nonfatal myocardial infarction, unplanned ischemia-driven revascularization, nonfatal stroke, hospitalization for heart failure
Measured: From enrollment to 1 year after primary percutaneous coronary intervention
Secondary outcomes (4)
Number of participants with coronary microvascular dysfunction (CMD)
Measurement of coronary angiography-derived microcirculation resistance index (caIMR)
Measured: Immediately after primary percutaneous coronary intervention
Number of participants with coronary microvascular dysfunction (CMD)
Infarct size (IS), intramyocardial hemorrhage (IMH) and microvascular obstruction (MVO) assessed by cardiac magnetic resonance
Measured: 3-7 days after primary percutaneous coronary intervention
Concentration of low density lipoprotein cholesterol (LDL-C)
The measurement of LDL-C level and number of participants reaching the target according to current guidelines
Measured: Both 1 month and 1 year after primary percutaneous coronary intervention
Rate of malignant arrhythmia
These include sudden cardiac death (SCD), sudden death survival (aborted SCD), appropriate implantable cardioverter defibrillator (ICD) interventions, and persistent ventricular arrhythmias monitored by a 72-hour holter electrocardiogram.
Measured: 1 month after primary percutaneous coronary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start20 Nov 2025 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (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.
- 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
- None (open label)
- Enrolment
- 1,160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yong Huo, M.D. and Ph.D., Study chair, Peking University First HospitalYuan Lu, M.D. and Ph.D., Principal investigator, The Affiliated Hospital of Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683131
- Sponsor's protocol ID
- XYFY2024-KL537-01
- Acronym
- IMPROVE-AMI
- Status last verified
- Nov 2024
- First submitted
- 8 Nov 2024
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants do not consent to the data sharing about themselves. IPD involves privacy and ethical issues.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMpact of PCSK9 inhibitoR initiatiOn Before Percutaneous Coronary Intervention on Coronary microVascular Dysfunction and Events for Acute Myocardial Infarction: a Multi-center, Open-label, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT06683131
- Acronym / sponsor ID
- IMPROVE-AMI / XYFY2024-KL537-01
- Conditions
- Acute Myocardial Infarction (AMI)
- Keywords
- Acute Myocardial Infarction, tafolecimab, PCSK9, Coronary Microvascular Dysfunction, Major adverse cardiovascular events, monoclonal antibody against proprotein convertase subtilisin/kexin type 9, LDL-C
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,160 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 20 Nov 2025 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 12 Nov 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.
The goal of this clinical trial is to learn if drug tafolecimab works to treat participants with acute myocardial infarction (AMI) scheduled for primary percutaneous coronary intervention (PCI). It will also learn about the safety of drug tafolecimab. The main questions it aims to answer are:
- Does drug tafolecimab lower the risk of 1-year major adverse cardiovascular events?
- Does drug tafolecimab improve the coronary microvascular dysfunction?
- What medical problems do participants have when administering drug tafolecimab by injection? Researchers will compare the results administering drug tafolecimab or not to see if drug tafolecimab works to treat AMI.
Participants will:
- Administer drug tafolecimab by injection or not every month for 12 months
- Receive the standard of care of AMI
- Complete the measurement of coronary angiography-derived microcirculation resistance index after PCI
- Complete cardiac magnetic resonance after PCI if available
- Visit the clinic at 1,6,12 months after the first administration for checkups and tests
- Report any discomfort, event or queries at any time
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCSK9 inhibitor (PCSK9i) group | Experimental | Drug: TafolecimabParticipants receive PCSK9i tafolecimab and standard of care (SoC) of acute myocardial infarction |
| Control group | No intervention | –Participants receive SoC of acute myocardial infarction |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults 18-75 years old
- AMI diagnosed according to the latest guidelines, including ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI)
- Regardless of baseline LDL-C levels
- Participants voluntarily took part in this study and signed informed consent
Key exclusion criteria (12 listed)
- Previous or ongoing treatment for any PCSK9i
- Allergy to PCSK9i, statins, or any of the drug ingredients used during the trial
- History of hemorrhagic cerebrovascular disease
- History of old myocardial infarction/chronic heart failure
- History of PCI or coronary artery bypass grafting (CABG) or preparation for CABG
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 |
|---|---|---|
| Tafolecimab450mg of tafolecimab (150mg each one) was injected subcutaneously before primary PCI and then 150mg subcutaneously injected every half a month till totally 12 months. | Drug | PCSK9 inhibitor (PCSK9i) group |
Primary outcome
Rate of major adverse cardiovascular events (MACEs)
Time frame: From enrollment to 1 year after primary percutaneous coronary intervention
MACEs including cardiovascular death, nonfatal myocardial infarction, unplanned ischemia-driven revascularization, nonfatal stroke, hospitalization for heart failure
4 secondary outcomes
Number of participants with coronary microvascular dysfunction (CMD)
Time frame: Immediately after primary percutaneous coronary intervention
Number of participants with coronary microvascular dysfunction (CMD)
Time frame: 3-7 days after primary percutaneous coronary intervention
Concentration of low density lipoprotein cholesterol (LDL-C)
Time frame: Both 1 month and 1 year after primary percutaneous coronary intervention
Rate of malignant arrhythmia
Time frame: 1 month after primary percutaneous coronary intervention
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 21 Nov 2025.
- Individual participant dataSharing planned: No. Participants do not consent to the data sharing about themselves. IPD involves privacy and ethical issues.
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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.
Yong Huo, M.D. and Ph.D. study chair
Peking University First Hospital
Yuan Lu, M.D. and Ph.D. principal investigator
The Affiliated Hospital of Xuzhou Medical University
13 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 Tafolecimab in people with Acute Myocardial Infarction (AMI), run by The Affiliated Hospital of Xuzhou Medical University at 13 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 6 inclusion and 12 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: opening soon, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
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 Yuan Lu, M.D. and Ph.D. (+8613952110901, drluyuan329@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of major adverse cardiovascular events (MACEs) (time frame: From enrollment to 1 year after primary percutaneous coronary intervention). 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 21 Nov 2025.