Coronary DiseaseNCT05184530
In-hospital Initiation of PCSK9 Inhibitor in Patients With Acute Myocardial Infarction
An observational study of Coronary Disease, run by First Affiliated Hospital Xi'an Jiaotong University.
Trial summary
Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors have been shown to improve cardiovascular outcomes when added to conventional statin therapy. This study aims to investigate the efficacy and safety of in-hospital initiation of PCSK9 inhibitor among patients with acute myocardial infarction(AMI) based… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Evolocumab 140 MG/ML
- Type of treatment
- Injection or infusion
- How many people
- 7,556 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2021
- Phase
- Observational
- 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
Study population: 7556 consecutive patients admitted to the cardiology department of the First Affiliated Hospital of Xi'an Jiaotong University for AMI between January 2016 and December 2020 were enrolled.
Who may be able to join
- confirmed admission diagnosis of AMI and were defined based on the universal definition criteria by the American Cardiology College
Who cannot join
- (1) severe noncardiac disease with an expected survival of less than 1 year and unwillingness to participate; (2) patients over the age of 80 years or living far away from the hospital's catchment area.
About this study
Official title: In-hospital Initiation of PCSK9 Inhibitor and Short-term Lipid Profile Alteration, as Well as In-hospital Mortality and Readmission Rate in Patients With Acute Myocardial Infarction
Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors have been shown to improve cardiovascular outcomes when added to conventional statin therapy. This study aims to investigate the efficacy and safety of in-hospital initiation of PCSK9 inhibitor among patients with acute myocardial infarction(AMI) based on real-world experience.
A total of 7556 AMI patients from the biobank database between January 2016 and December 2020 were screened for eligibility. After excluding those without revascularization or Statin based therapy, the remaining 5802 Statin users, 801 Statin plus Ezetimibe users and 170 Statin plus Evolocumab users (including 95 users without and 75 users with Ezetimibe), were selected for this study. Then, 1st and 3rd-month follow-up data were collected and analysed, including in-hospital mortality, readmission rate and lipid profiles
- Conditions
- Coronary Disease
- Being tested
- Evolocumab 140 MG/ML
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evolocumab 140 MG/MLDrug
140 mg per two weeks, subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Statin Group | AMI patients with Statin therapy. | |
| Ezetimibe Group | AMI patients with Statin plus Ezetimibe therapy. | |
| PCSK9i Group | AMI patients with Statin plus PCSK9i therapy. Receives: Drug: Evolocumab 140 MG/ML | |
| Triple Group | AMI patients with Statin plus Ezetimibe plus PCSK9i therapy Receives: Drug: Evolocumab 140 MG/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission rate
Measured: 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study startJan 2016
- Primary completionDec 2020
- Study completionDec 2021
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 Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 7,556 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, She JianQing, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184530
- Sponsor's protocol ID
- 82100477-1
- Status last verified
- Jan 2022
- First submitted
- 5 Jan 2022
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lou B, Liu H, Luo Y, Jiang GT, Wu H, Wang C, Wu Y, Zhou B, Yuan Z, She J, Liu J. In-hospital initiation of PCSK9 inhibitor and short-term lipid control in patients with acute myocardial infarction. Lipids Health Dis. 2022 Oct 24;21(1):105. doi: 10.1186/s12944-022-01724-9.
PubMed 36280861
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-hospital Initiation of PCSK9 Inhibitor and Short-term Lipid Profile Alteration, as Well as In-hospital Mortality and Readmission Rate in Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT05184530
- Acronym / sponsor ID
- 82100477-1
- Conditions
- Coronary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,556 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 11 Jan 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.
Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors have been shown to improve cardiovascular outcomes when added to conventional statin therapy. This study aims to investigate the efficacy and safety of in-hospital initiation of PCSK9 inhibitor among patients with acute myocardial infarction(AMI) based on real-world experience.
A total of 7556 AMI patients from the biobank database between January 2016 and December 2020 were screened for eligibility. After excluding those without revascularization or Statin based therapy, the remaining 5802 Statin users, 801 Statin plus Ezetimibe users and 170 Statin plus Evolocumab users (including 95 users without and 75 users with Ezetimibe), were selected for this study. Then, 1st and 3rd-month follow-up data were collected and analysed, including in-hospital mortality, readmission rate and lipid profiles
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Statin Group | – | –AMI patients with Statin therapy. |
| Ezetimibe Group | – | –AMI patients with Statin plus Ezetimibe therapy. |
| PCSK9i Group | – | Drug: Evolocumab 140 MG/MLAMI patients with Statin plus PCSK9i therapy. |
| Triple Group | – | Drug: Evolocumab 140 MG/MLAMI patients with Statin plus Ezetimibe plus PCSK9i therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 7556 consecutive patients admitted to the cardiology department of the First Affiliated Hospital of Xi'an Jiaotong University for AMI between January 2016 and December 2020 were enrolled.
Key inclusion criteria (1 listed)
- confirmed admission diagnosis of AMI and were defined based on the universal definition criteria by the American Cardiology College
Key exclusion criteria (1 listed)
- (1) severe noncardiac disease with an expected survival of less than 1 year and unwillingness to participate; (2) patients over the age of 80 years or living far away from the hospital's catchment area.
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 |
|---|---|---|
| Evolocumab 140 MG/ML140 mg per two weeks, subcutaneous injection | Drug | PCSK9i Group, Triple Group |
Primary outcome
Readmission rate
Time frame: 1 YEAR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Derived from this study: PubMed 36280861Lou B, Liu H, Luo Y, Jiang GT, Wu H, Wang C, Wu Y, Zhou B, Yuan Z, She J, Liu J. In-hospital initiation of PCSK9 inhibitor and short-term lipid control in patients with acute myocardial infarction. Lipids Health Dis. 2022 Oct 24;21(1):105. doi: 10.1186/s12944-022-01724-9.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease, run by First Affiliated Hospital Xi'an Jiaotong University.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readmission rate (time frame: 1 YEAR). 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 NCT05184530, 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 11 Jan 2022.