Early PCSK9 Inhibitor on Ventricular RemodlingPhase 4PERFECT-AMINCT04731155
Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium Infarction
A Phase 4 study testing PCSK9 inhibitor （Alirocumab）plus standard medications and standard medications in people with Early PCSK9 Inhibitor on Ventricular Remodling, run by Shanghai Tong Ren Hospital at 2 sites in China.
Trial summary
This is a prospect, multi-center, random study to investigate whether early offering PCSK9 inhibitor to acute myocardium infarction(AMI) can alleviate ventricular remodeling after primary percutaneous intervention(PPCI). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Early PCSK9 Inhibitor on Ventricular Remodling
- What is being tested?
- PCSK9 inhibitor （Alirocumab）plus standard medications and standard medications
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- 12 Apr 2021to Oct 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be at least 18 years of age and less than 80 years old
- Patients should have undergone successful percutaneous coronary intervention with drug-eluting stent for AMI and LAD should be the only culprit vessel.
- Subject understand the study requirements and the treatment procedures and provided informed consent before the procedure
Who cannot join
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
- Known hypersensitivity or contraindication to study medications
- Plan to receive revascularization in next six month.
- Have received revascularization before.
- Subjects with life expectation less than one year.
- Subjects with active malignant tumor
- subjects with severe liver or renal dysfunction（ALT >5倍ULA，eGFR<15ml/min/1.73mm2）
- Other conditions which the investigators think not applicable to the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Tongren Hospital, Shanghai
Shanghai, Shanghai Municipality
Lei Hou, Doctor, 13564868096, Dr_houlei@163.com
- Recruiting
Shanghai tenth people's hospital
Shanghai
Yi Zhang
About this study
Official title: Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium
This is a prospect, multi-center, random study to investigate whether early offering PCSK9 inhibitor to acute myocardium infarction(AMI) can alleviate ventricular remodeling after primary percutaneous intervention(PPCI). Totally,twenty acute myocardium infarction subjects will be enrolled in this study after consent information. After randomization, the control group will receive standard therapy for AMI including PPCI. The experiment group will receive first PCSK9 inhibitor before PPCI, then twice a month until 3 months later. Six month after AMI, Myocardial salvage index will be used to evaluate ventricular remodeling. TnI peaking time and LDL control rates also will be recorded and compared.
- Being tested
- PCSK9 inhibitor （Alirocumab）plus standard medications, standard medications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCSK9 inhibitor （Alirocumab）plus standard medicationsDrug
PCSK9 inhibitor（Alirocumab） was giving to subjects before PPCI and continued twice a month until 3 month after AMI
standard medicationsDrug
standard medications was giving to subjects according guidelines
| Study group | Role | What they receive |
|---|---|---|
| standard group | Active comparator | Not described Receives: Drug: standard medications |
| experiment group | Experimental | Not described Receives: Drug: PCSK9 inhibitor （Alirocumab）plus standard medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
myocardial salvage index measured by MRI
Measured: one week after PPCI
myocardial salvage index measured by MRI
Measured: six months after PPCI
eject fraction measured by MRI
Measured: one week after PPCI
eject fraction measured by MRI
Measured: six month after PPCI
Secondary outcomes (4)
the change of serum level of TnI/T
Measured: 0,6 ,12,18 , 24 ,30,and 36 hours after PPCI
LDL -C control rate
Measured: the first month after PPCI
the serum lever of hsCRP
Measured: Baseline (before PPCI)
the serum lever of hsCRP
Measured: one week after PPCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start12 Apr 2021
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early PCSK9 Inhibitor on Ventricular RemodlingStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Tong Ren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hou Lei, Shanghai Tong Ren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731155
- Sponsor's protocol ID
- 2021HL
- Acronym
- PERFECT-AMI
- Status last verified
- May 2025
- First submitted
- 23 Jan 2021
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium
- ClinicalTrials.gov ID
- NCT04731155
- Acronym / sponsor ID
- PERFECT-AMI / 2021HL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Tong Ren HospitalUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 29 Jan 2021 (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 prospect, multi-center, random study to investigate whether early offering PCSK9 inhibitor to acute myocardium infarction(AMI) can alleviate ventricular remodeling after primary percutaneous intervention(PPCI). Totally,twenty acute myocardium infarction subjects will be enrolled in this study after consent information. After randomization, the control group will receive standard therapy for AMI including PPCI. The experiment group will receive first PCSK9 inhibitor before PPCI, then twice a month until 3 months later. Six month after AMI, Myocardial salvage index will be used to evaluate ventricular remodeling. TnI peaking time and LDL control rates also will be recorded and compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard group | Active comparator | Drug: standard medications |
| experiment group | Experimental | Drug: PCSK9 inhibitor （Alirocumab）plus standard medications |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject must be at least 18 years of age and less than 80 years old
- Patients should have undergone successful percutaneous coronary intervention with drug-eluting stent for AMI and LAD should be the only culprit vessel.
- Subject understand the study requirements and the treatment procedures and provided informed consent before the procedure
Key exclusion criteria (8 listed)
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
- Known hypersensitivity or contraindication to study medications
- Plan to receive revascularization in next six month.
- Have received revascularization before.
- Subjects with life expectation less than one 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 |
|---|---|---|
| PCSK9 inhibitor （Alirocumab）plus standard medicationsPCSK9 inhibitor（Alirocumab） was giving to subjects before PPCI and continued twice a month until 3 month after AMI | Drug | experiment group |
| standard medicationsstandard medications was giving to subjects according guidelines | Drug | standard group |
Primary outcome
myocardial salvage index measured by MRI
Time frame: one week after PPCI
myocardial salvage index measured by MRI
Time frame: six months after PPCI
eject fraction measured by MRI
Time frame: one week after PPCI
eject fraction measured by MRI
Time frame: six month after PPCI
4 secondary outcomes
the change of serum level of TnI/T
Time frame: 0,6 ,12,18 , 24 ,30,and 36 hours after PPCI
LDL -C control rate
Time frame: the first month after PPCI
the serum lever of hsCRP
Time frame: Baseline (before PPCI)
the serum lever of hsCRP
Time frame: one week after PPCI
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 May 2025.
- Individual participant dataSharing planned: No
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.
2 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 PCSK9 inhibitor （Alirocumab）plus standard medications and standard medications in people with Early PCSK9 Inhibitor on Ventricular Remodling, run by Shanghai Tong Ren Hospital at 2 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 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 (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 measured by MRI (time frame: one week after PPCI). The study lists 4 primary outcomes in all. 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 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.