Ignite Creation Date:
2024-10-25 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06626126
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
Efficacy of Lipid-Lowering Therapy Based on Apolipoprotein B Versus LDL-Cholesterol Levels in Patients Undergoing Percutaneous Coronary Intervention
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of Lipid-Lowering Therapy Based on Apolipoprotein B Versus LDL-Cholesterol Levels in Patients Undergoing Percutaneous Coronary Intervention a Multicenter Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ApoB-guidedLLT
Brief Summary:
This multicenter randomized trial is designed to assess the efficacy of lipid-lowering therapy in patients undergoing percutaneous coronary intervention comparing an Apolipoprotein B-targeted approach with a Low-Density Lipoprotein Cholesterol LDL-C-targeted approach The primary outcomes are to evaluate the proportion of patients achieving lipid-lowering treatment goals at the 1-year follow-up between the two treatment strategies Apolipoprotein B-based therapy versus LDL-C-based therapy
Detailed Description:
This multicenter randomized trial is designed to assess the efficacy of lipid-lowering therapy in patients undergoing percutaneous coronary intervention comparing an Apolipoprotein B-targeted approach with a Low-Density Lipoprotein Cholesterol LDL-C-targeted approach The primary outcomes are to evaluate the proportion of patients achieving lipid-lowering treatment goals at the 1-year follow-up between the two treatment strategies Apolipoprotein B-based therapy versus LDL-C-based therapy
All patients with coronary artery diseases with PCI agreeing to participate will be included Patient data will be collected and managed through REDCap These data include information of patient demographics clinical history and presentations treatments and blood test results The data collection forms are based on EUROHEART data set
After undergoing percutaneous coronary intervention with drug-eluting stents participants will be randomly allocated to one of two groups
1 Patients managed with lipid-lowering therapy targeting LDL-C levels
2 Patients managed with lipid-lowering therapy targeting Apolipoprotein B levels Follow-up assessments will take place at 1 2 6 and 12 months post-discharge During these outpatient visits a full lipid profile will be performed including total cholesterol LDL-C HDL-C triglycerides and Apolipoprotein B Treatment regimens will be adjusted accordingly to meet the respective targets LDL-C below 55 mgdL or Apolipoprotein B below 65 mgdL
Moreover the study aims to assess the incidence of major cardiovascular events such as all-cause mortality myocardial infarction target vessel revascularization and stroke at the 1-year follow-up These outcomes will be compared between the two groups to evaluate the efficacy of Apolipoprotein B-targeted therapy versus LDL-C-targeted therapy in achieving lipid-lowering goals
The data will be entered into the REDCap program which will subsequently be processed with the R 410 program With a p value ampamplt 005 and a 95 percent confidence interval all of the analyses are statistically significant The investigators employ descriptive statistics one-variable statistics and statistics with multiple variables Qualitative data will be presented as rates and percentages using descriptive statistics the data will then be processed using the Chi-square test The investigators report quantitative data as mean standard deviation for normal distributions and median interquartile range for other distributions The investigators will use an unpaired t-test to compare means
Primary Outcome Measures To evaluate the therapeutic efficacy of lipid-lowering therapy predicated on target Apolipoprotein B or target Low-Density Lipoprotein Cholesterol LDL-C levels at the one-year follow-up in patients undergoing percutaneous coronary intervention PCI Specifically the primary objective is to conduct a comparative analysis of the achievement rates of lipid-lowering therapeutic targets at the one-year in PCI patients between two cohorts one receiving therapy tailored to Apolipoprotein B targets versus another receiving treatment based on LDL-C targets
Secondary Outcome Measures
1 To evaluate the comparative effectiveness of lipid-lowering therapies guided by Apolipoprotein B or LDL-C target levels at the one-year follow-up in post-PCI patients with a particular focus on comparing the incidence of major adverse cardiovascular events MACE including all-cause mortality myocardial infarction target vessel revascularization and stroke between the two treatment groups one group managed to Apolipoprotein B targets and the other to LDL-C targets
2 To compare the incidence and severity of adverse drug reactions ADRs associated with lipid-lowering therapies between the two study groups at the one-year follow-up with one group managed to Apolipoprotein B targets and the other managed to LDL-C targets
All patients with coronary artery diseases with PCI agreeing to participate will be included Patient data will be collected and managed through REDCap These data include information of patient demographics clinical history and presentations treatments and blood test results The data collection forms are based on EUROHEART data set
After undergoing percutaneous coronary intervention with drug-eluting stents participants will be randomly allocated to one of two groups
1 Patients managed with lipid-lowering therapy targeting LDL-C levels
2 Patients managed with lipid-lowering therapy targeting Apolipoprotein B levels Follow-up assessments will take place at 1 2 6 and 12 months post-discharge During these outpatient visits a full lipid profile will be performed including total cholesterol LDL-C HDL-C triglycerides and Apolipoprotein B Treatment regimens will be adjusted accordingly to meet the respective targets LDL-C below 55 mgdL or Apolipoprotein B below 65 mgdL
Moreover the study aims to assess the incidence of major cardiovascular events such as all-cause mortality myocardial infarction target vessel revascularization and stroke at the 1-year follow-up These outcomes will be compared between the two groups to evaluate the efficacy of Apolipoprotein B-targeted therapy versus LDL-C-targeted therapy in achieving lipid-lowering goals
The data will be entered into the REDCap program which will subsequently be processed with the R 410 program With a p value ampamplt 005 and a 95 percent confidence interval all of the analyses are statistically significant The investigators employ descriptive statistics one-variable statistics and statistics with multiple variables Qualitative data will be presented as rates and percentages using descriptive statistics the data will then be processed using the Chi-square test The investigators report quantitative data as mean standard deviation for normal distributions and median interquartile range for other distributions The investigators will use an unpaired t-test to compare means
Primary Outcome Measures To evaluate the therapeutic efficacy of lipid-lowering therapy predicated on target Apolipoprotein B or target Low-Density Lipoprotein Cholesterol LDL-C levels at the one-year follow-up in patients undergoing percutaneous coronary intervention PCI Specifically the primary objective is to conduct a comparative analysis of the achievement rates of lipid-lowering therapeutic targets at the one-year in PCI patients between two cohorts one receiving therapy tailored to Apolipoprotein B targets versus another receiving treatment based on LDL-C targets
Secondary Outcome Measures
1 To evaluate the comparative effectiveness of lipid-lowering therapies guided by Apolipoprotein B or LDL-C target levels at the one-year follow-up in post-PCI patients with a particular focus on comparing the incidence of major adverse cardiovascular events MACE including all-cause mortality myocardial infarction target vessel revascularization and stroke between the two treatment groups one group managed to Apolipoprotein B targets and the other to LDL-C targets
2 To compare the incidence and severity of adverse drug reactions ADRs associated with lipid-lowering therapies between the two study groups at the one-year follow-up with one group managed to Apolipoprotein B targets and the other managed to LDL-C targets
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None