Lipid MetabolismNCT04730648
Acute Myocardial Infarction and Unstable Angina Patients With PCSK9 Inhibitor Usage Study
A study testing PCSK9 inhibitor in people with Lipid Metabolism and Cardiovascular Diseases, run by Shenzhen People's Hospital at 1 site in China.
Trial summary
Acute coronary syndrome (ACS) is a lethal disease, reduced low-density lipoprotein (LDL) cholesterol due to inhibition of proprotein convertase subtilisin/kexin 9 (PCSK9) reduces cardiovascular events and improve cardiovascular prognosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lipid Metabolism, Cardiovascular Diseases
- What is being tested?
- PCSK9 inhibitor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2021to 23 Apr 2023
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New diagnosis ACS patient by serum biomarker and coronary arteriography.
Who cannot join
- Severe renal dysfunction acute or chronic bacterial and viral infections sleep apnea cancer
Trial locations and contacts
1 site in 1 country.
Shaohong Dong, PhD. contact
China1 site, 1 recruiting
- Recruiting
Tangzhiming Li
Shenzhen, Guangdong, 518020
Tangzhiming Li, PhD., +86 18588269277, litangzhiming@126.com
Shaohong Dong, PhD., +86 13509633742, 119538892@qq.com
About this study
Acute coronary syndrome (ACS) is a lethal disease, reduced low-density lipoprotein (LDL) cholesterol due to inhibition of proprotein convertase subtilisin/kexin 9 (PCSK9) reduces cardiovascular events and improve cardiovascular prognosis. we assuming that PCSK9 inhibitor could bring metabolic change in serum, in order to investigate the metabolic modification, we conduct this clinical trial.
- Conditions
- Lipid Metabolism, Cardiovascular Diseases
- Being tested
- PCSK9 inhibitor
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCSK9 inhibitorDrug
For newly diagnosed ACS patients with diabetes, multivessel occlusion, or recurrent ACS attack, who are willing to accept PCSK9 inhibitor injection.
| Study group | Role | What they receive |
|---|---|---|
| pcsk9 inhibitor group | Experimental | patients with severe coronary stenosis diagnosed ACS. The baseline blood and urine would be collected, thereafter, the PCSK9 inhibitor would be injected. 64-72 hours after, the blood and urine sample collection would be performed. Receives: Drug: PCSK9 inhibitor |
| control group | No intervention | Patients with comparable age, sex ratio, and BMI, but coronary arteries are relatively normal evaluated by coronary angiography. their blood and urine would be collected as the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascular prognosis
composite outcome of time to first occurrence of cardiovascular death, myocardial infarction, unstable angina and heart failure.
Measured: 52 weeks
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 start22 Apr 2021
- Primary completion23 Apr 2022
- Study completion23 Apr 2023 (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 Lipid MetabolismStudies 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 N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Li, Shenzhen People's Hospital
- Investigators
- Tangzhiming Li, PhD., Principal investigator, Department of Cardiology, Shenzhen People's Hospital, Shenzhen 518020, Guangdong, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730648
- Sponsor's protocol ID
- Among-Us study
- Status last verified
- May 2022
- First submitted
- 26 Nov 2020
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ou Z, Yu Z, Liang B, Zhao L, Li J, Pang X, Liu Q, Xu C, Dong S, Sun X, Li T. Evolocumab enables rapid LDL-C reduction and inflammatory modulation during in-hospital stage of acute coronary syndrome: A pilot study on Chinese patients. Front Cardiovasc Med. 2022 Aug 9;9:939791. doi: 10.3389/fcvm.2022.939791. eCollection 2022.
PubMed 36017088
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Myocardial Infarction and Unstable Angina Patients With PCSK9 Inhibitor Usage Study
- ClinicalTrials.gov ID
- NCT04730648
- Acronym / sponsor ID
- Among-Us study
- Conditions
- Lipid Metabolism, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 23 Apr 2022 (actual)
- Study completion
- 23 Apr 2023 (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.
Acute coronary syndrome (ACS) is a lethal disease, reduced low-density lipoprotein (LDL) cholesterol due to inhibition of proprotein convertase subtilisin/kexin 9 (PCSK9) reduces cardiovascular events and improve cardiovascular prognosis. we assuming that PCSK9 inhibitor could bring metabolic change in serum, in order to investigate the metabolic modification, we conduct this clinical trial.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pcsk9 inhibitor group | Experimental | Drug: PCSK9 inhibitorpatients with severe coronary stenosis diagnosed ACS. The baseline blood and urine would be collected, thereafter, the PCSK9 inhibitor would be injected. 64-72 hours after, the blood and urine sample collection would be performed. |
| control group | No intervention | –Patients with comparable age, sex ratio, and BMI, but coronary arteries are relatively normal evaluated by coronary angiography. their blood and urine would be collected as the control group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- New diagnosis ACS patient by serum biomarker and coronary arteriography.
Key exclusion criteria (1 listed)
- Severe renal dysfunction acute or chronic bacterial and viral infections sleep apnea cancer
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 inhibitorFor newly diagnosed ACS patients with diabetes, multivessel occlusion, or recurrent ACS attack, who are willing to accept PCSK9 inhibitor injection. | Drug | pcsk9 inhibitor group |
Primary outcome
cardiovascular prognosis
Time frame: 52 weeks
composite outcome of time to first occurrence of cardiovascular death, myocardial infarction, unstable angina and heart failure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Derived from this study: PubMed 36017088Ou Z, Yu Z, Liang B, Zhao L, Li J, Pang X, Liu Q, Xu C, Dong S, Sun X, Li T. Evolocumab enables rapid LDL-C reduction and inflammatory modulation during in-hospital stage of acute coronary syndrome: A pilot study on Chinese patients. Front Cardiovasc Med. 2022 Aug 9;9:939791. doi: 10.3389/fcvm.2022.939791. 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. This study is not recruiting at the moment.
Shaohong Dong, PhD. contact
Tangzhiming Li, PhD. principal investigator
Department of Cardiology, Shenzhen People's Hospital, Shenzhen 518020, Guangdong, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCSK9 inhibitor in people with Lipid Metabolism and Cardiovascular Diseases, run by Shenzhen People's 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 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: status not confirmed, as of the sponsor's last update on 5 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tangzhiming Li, PhD. (+86 18588269277, litangzhiming@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiovascular prognosis (time frame: 52 weeks). 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 NCT04730648, 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 5 May 2022.