Acute Myocardial InfarctionPhase 4NCT05292404
Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction
A Phase 4 study testing alirocumab and conventional treatment in people with Acute Myocardial Infarction, run by Shanghai Tong Ren Hospital at 5 sites in China.
Trial summary
This is a multi-center, prospective, randomized, controlled study. The patients with STEMI who were to undergo PPCI were divided into PCSK9 inhibitor group (n=80) and conventional treatment group (n=80) using the interactive web response system (IWRS), at a 1:1 ratio. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- alirocumab and conventional treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 5 sitesChina
- Study dates
- 1 Oct 2022to Dec 2026
- 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
- The age is greater than 18 years old and less than or equal to 80 years old.
- Patients who are clinically diagnosed with STEMI onset within 24 hours and who are planning to undergo PPCI .
- Signed informed consent.
Who cannot join
- Patients who are allergic to PCSK9 inhibitors.
- Multivessel disease planned for selective intervention within half a year.
- Patients who have previously undergone revascularization.
- Pregnant women or women who plan to become pregnant in the next 2 years.
- Patients whose life expectancy is less than 1 year.
- Severe liver or kidney dysfunction (ALT>5 times ULA, eGFR<15ml/min/1.73m2)
- Known active malignant tumor diseases.
- Patients considered by the investigator to be unsuitable to participate in this study.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
nineth people's hospital, School of Medicine, shanghai jiaotong university
Shanghai, Shanghai Municipality, 200050
Junfeng Zhang, doctor
- Recruiting
Shanghai chest hospital
Shanghai, Shanghai Municipality, 200050
zhenchi sang, doctor
- Recruiting
Shanghai tongren hospital
Shanghai, Shanghai Municipality, 200050
Lei Hou, doctor, Dr_houlei@163.com
Lei Hou, doctor
- Recruiting
tenth people's hospital, tongji university, Shanghai
Shanghai, Shanghai Municipality, 200050
Yi Zhang, doctor
- Recruiting
Songjiang hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Tongqing Yao, doc
About this study
Official title: Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction： a Muti-center, Open-label, Randomized Controlled Trial
This is a multi-center, prospective, randomized, controlled study. The patients with STEMI who were to undergo PPCI were divided into PCSK9 inhibitor group (n=80) and conventional treatment group (n=80) using the interactive web response system (IWRS), at a 1:1 ratio. In the PCSK9 inhibitor group, a dose of PCSK9 inhibitor (alirocumab) was injected subcutaneously immediately after PPCI and was administered every two weeks thereafter for 3 months; the control group received conventional treatment. Cardiac Magnetic Resonance Imaging (MRI) were used to measure myocardial salvage index at 1 week after operation as primary endpoints. Eject fraction at 6 months after operation will also be measured by MRI as secondary endpoints. Serum TnI/T，CKMB levels were detected q8h for three times and and LDL-C levels were detected at 1 month, 3 months and 6 months after operation. Blood inflammation indicators were detected before and 1 week after the operation, and 6 months after the operation.
- Conditions
- Acute Myocardial Infarction
- Being tested
- alirocumab, conventional treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alirocumabDrug
In the PCSK9 inhibitor group, a dose of PCSK9 inhibitor (alirocumab,75mg) was injected subcutaneously immediately after PPCI and was administered every two weeks thereafter for 3 months
conventional treatmentOther
conventional treatment were given according to international uniformguidelines
| Study group | Role | What they receive |
|---|---|---|
| Early PCSK9 inhibitor treatment group | Experimental | Not described Receives: Drug: alirocumab |
| conventional treatment group | Other | Not described Receives: Other: conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
myocardial salvage index
measured by Magnetic Resonance Imaging (MRI)
Measured: 1 week after operation
Secondary outcomes (1)
Eject fraction
measured by MRI
Measured: at 6 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start1 Oct 2022
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies 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
- Model description
- PCSK9 inhibitor
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Tong Ren Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China Cardiovascular Association
- Responsible party
- Principal investigator, Hou Lei, Shanghai Tong Ren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292404
- Sponsor's protocol ID
- ShanghaiTRH-HL2022
- Status last verified
- Dec 2025
- First submitted
- 13 Mar 2022
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Xia J, Wang X, Zhou J, Wang D, Pang Y, Xu X, Sang Z, Zhang Y, Zhang J, Wu S, Xiao Z, Hou L. Impact of early PCSK9 inhibitor treatment on heart after percutaneous coronary intervention in patients with STEMI: Design and rationale of the PERFECT II trial. Front Cardiovasc Med. 2022 Sep 23;9:1009674. doi: 10.3389/fcvm.2022.1009674. eCollection 2022.
PubMed 36211588
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 Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction： a Muti-center, Open-label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05292404
- Acronym / sponsor ID
- ShanghaiTRH-HL2022
- Conditions
- Acute Myocardial Infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Shanghai Tong Ren HospitalUniversity, hospital or other
- Collaborators
- China Cardiovascular Association
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Mar 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.
This is a multi-center, prospective, randomized, controlled study. The patients with STEMI who were to undergo PPCI were divided into PCSK9 inhibitor group (n=80) and conventional treatment group (n=80) using the interactive web response system (IWRS), at a 1:1 ratio. In the PCSK9 inhibitor group, a dose of PCSK9 inhibitor (alirocumab) was injected subcutaneously immediately after PPCI and was administered every two weeks thereafter for 3 months; the control group received conventional treatment. Cardiac Magnetic Resonance Imaging (MRI) were used to measure myocardial salvage index at 1 week after operation as primary endpoints. Eject fraction at 6 months after operation will also be measured by MRI as secondary endpoints. Serum TnI/T，CKMB levels were detected q8h for three times and and LDL-C levels were detected at 1 month, 3 months and 6 months after operation. Blood inflammation indicators were detected before and 1 week after the operation, and 6 months after the operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- PCSK9 inhibitor
| Arm | Type | Receives |
|---|---|---|
| Early PCSK9 inhibitor treatment group | Experimental | Drug: alirocumab |
| conventional treatment group | Other | Other: conventional treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The age is greater than 18 years old and less than or equal to 80 years old.
- Patients who are clinically diagnosed with STEMI onset within 24 hours and who are planning to undergo PPCI .
- Signed informed consent.
Key exclusion criteria (8 listed)
- Patients who are allergic to PCSK9 inhibitors.
- Multivessel disease planned for selective intervention within half a year.
- Patients who have previously undergone revascularization.
- Pregnant women or women who plan to become pregnant in the next 2 years.
- Patients whose life expectancy is less than 1 year.
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 |
|---|---|---|
| alirocumabIn the PCSK9 inhibitor group, a dose of PCSK9 inhibitor (alirocumab,75mg) was injected subcutaneously immediately after PPCI and was administered every two weeks thereafter for 3 months | Drug | Early PCSK9 inhibitor treatment group |
| conventional treatmentconventional treatment were given according to international uniformguidelines | Other | conventional treatment group |
Primary outcome
myocardial salvage index
Time frame: 1 week after operation
measured by Magnetic Resonance Imaging (MRI)
1 secondary outcome
Eject fraction
Time frame: at 6 months after operation
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.
- Derived from this study: PubMed 36211588Xia J, Wang X, Zhou J, Wang D, Pang Y, Xu X, Sang Z, Zhang Y, Zhang J, Wu S, Xiao Z, Hou L. Impact of early PCSK9 inhibitor treatment on heart after percutaneous coronary intervention in patients with STEMI: Design and rationale of the PERFECT II trial. Front Cardiovasc Med. 2022 Sep 23;9:1009674. doi: 10.3389/fcvm.2022.1009674. eCollection 2022.
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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.
5 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 alirocumab and conventional treatment in people with Acute Myocardial Infarction, run by Shanghai Tong Ren Hospital at 5 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 3 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: 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 5 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 Lei Hou, doctor (86-13564868096, Dr_houlei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
myocardial salvage index (time frame: 1 week after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05292404, which also lists 1 linked publication.
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.