Acute Coronary SyndromePhase 4NCT05298475
Low-dose PCSK9 Inhibitor Combined With Stains on Serum Lipids in Chinese Population With Acute Coronary Syndrome
A Phase 4 study testing Statin and PCSK9 inhibitor in people with Acute Coronary Syndrome, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
A total of 100 patients aged 18-85 years old with a definite diagnosis of ACS were admitted to the Department of Cardiovascular, The First Affiliated Hospital of Nanjing Medical University. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Statin and 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
- 1 Apr 2022to 1 Apr 2024
- Phase
- Phase 4
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-85 years, gender unlimited;
- Diagnosed with acute coronary syndrome;
- The fasting LDL-C≥1.8mmol/L (70mg/dL);
- Subjects participated in the study voluntarily and signed informed consent.
Who cannot join
- Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) > 180 mmHg or diastolic BP (DBP) > 110 mmHg；
- Last known left ventricular ejection fraction < 30%
- Known hemorrhagic stroke at any time；
- Severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73m2 at final screening；
- Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times；
- LDL or plasma apheresis within 12 months prior to randomization；
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- Pregnant or lactating women；
- Severe, concomitant non-cardiovascular disease that is expected to reduce life expectancy to less than 3 years；
- Patients allergic to PCSK9 inhibitors.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Official title: Short-term Effect of Modified 、Low-dose Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor Combined With Stains on Serum Lipids in Chinese Population With Acute Coronary Syndrome : the Singe-center 、Real-world Study
A total of 100 patients aged 18-85 years old with a definite diagnosis of ACS were admitted to the Department of Cardiovascular, The First Affiliated Hospital of Nanjing Medical University. These patients had fasting serum low-density lipoprotein (LDL-C) >1.8mmol/L (70mg/dL) and were divided into three groups according to the lipid-lowering regimen used: a total of 50 people in the statin-only group received a daily oral medium-dose statin (atorvastatin 20mg qn or rosuvastatin 10mg qn); a total of 30 people in the statin + one injection group per month received oral atorvastatin 20mg qn or rosuvastatin 10mg qn + once a month, subcutaneous injection of 1 injection of PCSK9 inhibitor each time; the remaining 20 people were divided into statin + two injections per month group, oral atorvastatin 20mg qn or rosuvastatin 10mg qn + twice a month, subcutaneous injection of 1 injection of PCSK9 inhibitor each time. We followed up the blood lipid levels of these patients at different time points (one month,three month, six month), including TC, TG, HDL-C, LDL-C,taking the LDL-C reduction ≥50% from the baseline, LDL-C<1.8mmol/L (70mg/dL), and LDL-C<1.4mmol/L (55mg/dL) as the the compliance standard, the blood lipid compliance rates of the three groups at the 6th month of treatment were calculated respectively. The adverse drug reactions of the patients during follow-up were recorded.
Read the detailed description
Purpose:The purpose of this study was to explore the short-term effect of a modified, lower-than-guideline-recommended doses of PCSK9 inhibitors combined with a statin in the treatment of dyslipidemia in Chinese with the acute coronary syndrome (ACS), to provide evidence for the use of this drug in real-world Chinese populations. This study will provide more economical, convenient, and acceptable treatment options.
A total of 100 patients aged 18-85 years old with a definite diagnosis of ACS were admitted to the Department of Cardiovascular, The First Affiliated Hospital of Nanjing Medical University. These patients had fasting serum low-density lipoprotein (LDL-C) >1.8mmol/L (70mg/dL) and were divided into three groups according to the lipid-lowering regimen used: a total of 50 people in the statin-only group received a daily oral medium-dose statin (atorvastatin 20mg qn or rosuvastatin 10mg qn); a total of 30 people in the statin + one injection group per month received oral atorvastatin 20mg qn or rosuvastatin 10mg qn + once a month, subcutaneous injection of 1 injection of PCSK9 inhibitor each time; the remaining 20 people were divided into statin + two injections per month group, oral atorvastatin 20mg qn or rosuvastatin 10mg qn + twice a month, subcutaneous injection of 1 injection of PCSK9 inhibitor each time. We followed up the blood lipid levels of these patients at different time points (one month,three month, six month), including TC, TG, HDL-C, LDL-C, taking the LDL-C reduction ≥50% from the baseline, LDL-C<1.8mmol/L (70mg/dL), and LDL-C<1.4mmol/L (55mg/dL) as the the compliance standard, the blood lipid compliance rates of the three groups at the 6th month of treatment were calculated respectively. The adverse drug reactions of the patients during follow-up were recorded.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Statin, PCSK9 inhibitor
- Keywords
- Acute coronary syndrome, Serum lipids, PCSK9 inhibitor, Statin
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StatinDrug
Medium-dose statin daily(atorvastatin 20mg qn or rosuvastatin 10mg qn)
PCSK9 inhibitorDrug
1 injection of PCSK9 inhibitor once a month SC
PCSK9 inhibitorDrug
1 injection of PCSK9 inhibitor twice a month SC
| Study group | Role | What they receive |
|---|---|---|
| Statin-only group | Experimental | The patients in this group are treated with medium-dose statin daily(atorvastatin 20mg qn or rosuvastatin 10mg qn). Receives: Drug: Statin |
| Low-dose PCSK9 inhibitor group | Experimental | The patients in this group are treated with medium-dose statin daily(atorvastatin 20mg qn or rosuvastatin 10mg qn) and 1 injection of PCSK9 inhibitor once a month SC. Receives: Drug: Statin; Drug: PCSK9 inhibitor |
| Normal-dose PCSK9 inhibitor group | Experimental | The patients in this group are treated with medium-dose statin daily(atorvastatin 20mg qn or rosuvastatin 10mg qn) and 1 injection of PCSK9 inhibitor twice a month SC. Receives: Drug: Statin; Drug: PCSK9 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of total cholesterol(TC)
The level of total cholesterol(TC) at 6 month
Measured: 6 month
The level of triglyceride(TG)
The level of triglyceride(TG) at 6 month
Measured: 6 month
The level of high-density lipoprotein cholesterol(HDL-C)
The level of high-density lipoprotein cholesterol(HDL-C) at 6 month
Measured: 6 month
The level of low-density lipoprotein cholesterol(LDL-C)
The level of low-density lipoprotein cholesterol(LDL-C) at 6 month
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start1 Apr 2022 (estimated)
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298475
- Sponsor's protocol ID
- EPICS-CHACS
- Status last verified
- Mar 2022
- First submitted
- 13 Mar 2022
- Last updated
- 28 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effect of Modified 、Low-dose Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor Combined With Stains on Serum Lipids in Chinese Population With Acute Coronary Syndrome : the Singe-center 、Real-world Study
- ClinicalTrials.gov ID
- NCT05298475
- Acronym / sponsor ID
- EPICS-CHACS
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute coronary syndrome, Serum lipids, PCSK9 inhibitor, Statin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 28 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.
A total of 100 patients aged 18-85 years old with a definite diagnosis of ACS were admitted to the Department of Cardiovascular, The First Affiliated Hospital of Nanjing Medical University. These patients had fasting serum low-density lipoprotein (LDL-C) >1.8mmol/L (70mg/dL) and were divided into three groups according to the lipid-lowering regimen used: a total of 50 people in the statin-only group received a daily oral medium-dose statin (atorvastatin 20mg qn or rosuvastatin 10mg qn); a total of 30 people in the statin + one injection group per month received oral atorvastatin 20mg qn or rosuvastatin 10mg qn + once a month, subcutaneous injection of 1 injection of PCSK9 inhibitor each time; the remaining 20 people were divided into statin + two injections per month group, oral atorvastatin 20mg qn or rosuvastatin 10mg qn + twice a month, subcutaneous injection of 1 injection of PCSK9 inhibitor each time. We followed up the blood lipid levels of these patients at different time points (one month,three month, six month), including TC, TG, HDL-C, LDL-C,taking the LDL-C reduction ≥50% from the baseline, LDL-C<1.8mmol/L (70mg/dL), and LDL-C<1.4mmol/L (55mg/dL) as the the compliance standard, the blood lipid compliance rates of the three groups at the 6th month of treatment were calculated respectively. The adverse drug reactions of the patients during follow-up were recorded.
Detailed description
Purpose:The purpose of this study was to explore the short-term effect of a modified, lower-than-guideline-recommended doses of PCSK9 inhibitors combined with a statin in the treatment of dyslipidemia in Chinese with the acute coronary syndrome (ACS), to provide evidence for the use of this drug in real-world Chinese populations. This study will provide more economical, convenient, and acceptable treatment options.
A total of 100 patients aged 18-85 years old with a definite diagnosis of ACS were admitted to the Department of Cardiovascular, The First Affiliated Hospital of Nanjing Medical University. These patients had fasting serum low-density lipoprotein (LDL-C) >1.8mmol/L (70mg/dL) and were divided into three groups according to the lipid-lowering regimen used: a total of 50 people in the statin-only group received a daily oral medium-dose statin (atorvastatin 20mg qn or rosuvastatin 10mg qn); a total of 30 people in the statin + one injection group per month received oral atorvastatin 20mg qn or rosuvastatin 10mg qn + once a month, subcutaneous injection of 1 injection of PCSK9 inhibitor each time; the remaining 20 people were divided into statin + two injections per month group, oral atorvastatin 20mg qn or rosuvastatin 10mg qn + twice a month, subcutaneous injection of 1 injection of PCSK9 inhibitor each time. We followed up the blood lipid levels of these patients at different time points (one month,three month, six month), including TC, TG, HDL-C, LDL-C, taking the LDL-C reduction ≥50% from the baseline, LDL-C<1.8mmol/L (70mg/dL), and LDL-C<1.4mmol/L (55mg/dL) as the the compliance standard, the blood lipid compliance rates of the three groups at the 6th month of treatment were calculated respectively. The adverse drug reactions of the patients during follow-up were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Statin-only group | Experimental | Drug: StatinThe patients in this group are treated with medium-dose statin daily(atorvastatin 20mg qn or rosuvastatin 10mg qn). |
| Low-dose PCSK9 inhibitor group | Experimental | Drug: Statin, Drug: PCSK9 inhibitorThe patients in this group are treated with medium-dose statin daily(atorvastatin 20mg qn or rosuvastatin 10mg qn) and 1 injection of PCSK9 inhibitor once a month SC. |
| Normal-dose PCSK9 inhibitor group | Experimental | Drug: Statin, Drug: PCSK9 inhibitorThe patients in this group are treated with medium-dose statin daily(atorvastatin 20mg qn or rosuvastatin 10mg qn) and 1 injection of PCSK9 inhibitor twice a month SC. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-85 years, gender unlimited;
- Diagnosed with acute coronary syndrome;
- The fasting LDL-C≥1.8mmol/L (70mg/dL);
- Subjects participated in the study voluntarily and signed informed consent.
Key exclusion criteria (9 listed)
- Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) > 180 mmHg or diastolic BP (DBP) > 110 mmHg；
- Last known left ventricular ejection fraction < 30%
- Known hemorrhagic stroke at any time；
- Severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73m2 at final screening；
- Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times；
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 |
|---|---|---|
| StatinMedium-dose statin daily(atorvastatin 20mg qn or rosuvastatin 10mg qn) | Drug | Low-dose PCSK9 inhibitor group, Normal-dose PCSK9 inhibitor group, Statin-only group |
| PCSK9 inhibitor1 injection of PCSK9 inhibitor once a month SC | Drug | Low-dose PCSK9 inhibitor group |
| PCSK9 inhibitor1 injection of PCSK9 inhibitor twice a month SC | Drug | Normal-dose PCSK9 inhibitor group |
Primary outcome
The level of total cholesterol(TC)
Time frame: 6 month
The level of total cholesterol(TC) at 6 month
The level of triglyceride(TG)
Time frame: 6 month
The level of triglyceride(TG) at 6 month
The level of high-density lipoprotein cholesterol(HDL-C)
Time frame: 6 month
The level of high-density lipoprotein cholesterol(HDL-C) at 6 month
The level of low-density lipoprotein cholesterol(LDL-C)
Time frame: 6 month
The level of low-density lipoprotein cholesterol(LDL-C) at 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Statin and PCSK9 inhibitor in people with Acute Coronary Syndrome, run by The First Affiliated Hospital with Nanjing Medical University 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 4 inclusion and 9 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 28 Mar 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liansheng Wang (+86 13390787111, jsyzcxw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of total cholesterol(TC) (time frame: 6 month). 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 28 Mar 2022.