Ignite Creation Date:
2024-05-06 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05298475
Status:
UNKNOWN
Last Update Posted:
2022-03-28
First Post:
2022-03-13
Brief Title:
Low-dose PCSK9 Inhibitor Combined With Stains on Serum Lipids in Chinese Population With Acute Coronary Syndrome
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
Official Title:
Short-term Effect of Modified Low-dose Proprotein Convertase SubtilisinKexin Type 9 Inhibitor Combined With Stains on Serum Lipids in Chinese Population With Acute Coronary Syndrome the Singe-center Real-world Study
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 These patients had fasting serum low-density lipoprotein LDL-C 18mmolL 70mgdL 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 monththree month six month including TC TG HDL-C LDL-Ctaking the LDL-C reduction 50 from the baseline LDL-C18mmolL 70mgdL and LDL-C14mmolL 55mgdL 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:
PurposeThe 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 18mmolL 70mgdL 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 monththree month six month including TC TG HDL-C LDL-C taking the LDL-C reduction 50 from the baseline LDL-C18mmolL 70mgdL and LDL-C14mmolL 55mgdL 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
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 18mmolL 70mgdL 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 monththree month six month including TC TG HDL-C LDL-C taking the LDL-C reduction 50 from the baseline LDL-C18mmolL 70mgdL and LDL-C14mmolL 55mgdL 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None