Efficacy of Lipid-Lowering Therapy Based on Apolipoprotein B Versus LDL-Cholesterol Levels in Patients Undergoing Percutaneous Coronary Intervention (ApoB-guidedLLT)
Efficacy of Lipid-Lowering Therapy Based on Apolipoprotein B Versus LDL-Cholesterol Levels in Patients Undergoing Percutaneous Coronary Intervention: a Multicenter, Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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:
- Patients managed with lipid-lowering therapy targeting LDL-C levels
- 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 mg/dL or Apolipoprotein B below 65 mg/dL.
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 4.1.0 program. With a p value < 0.05 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
- 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.
- 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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Vu Hoang Vu, Ph.D M.D
- Phone Number: +84908431304
- Email: vu.vh@umc.edu.vn
Study Contact Backup
- Name: Bao Thien Duong, M.D
- Phone Number: +84936287137
- Email: bao.dt1@umc.edu.vn
Study Locations
-
-
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Ho Chi Minh City, Vietnam, 700000
- University Medical Center Ho Chi Minh City
-
Contact:
- Vu Hoang Vu, Ph.D M.D
- Phone Number: +84908431304
- Email: vu.vh@umc.edu.vn
-
Contact:
- Bao Thien Duong, M.D
- Phone Number: +84936287137
- Email: bao.dt1@umc.edu.vn
-
Contact:
- Vu Hoang Vu, Ph.D M.D
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged 18 years or older.
- Patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES).
- Patients who agree to participate and provide informed consent.
Exclusion Criteria:
- Inability to Provide Informed Consent: Patients who are unable or unwilling to provide consent.
- Limited life expectancy: patients with a life expectancy of less than 12 months due to other non-cardiac conditions.
- Liver Disease: patients with cirrhosis or significant liver dysfunction.
- Patients with contraindication to statin or other lipid-lowering therapy.
- Any condition that may interfere with the study process, including treatment adherence or follow-up appointments (e.g., dementia, alcohol abuse, severe debilitation, long distances required for follow-up, etc.).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: LDL-C guided-LLT
Patients in this group will receive treatment regimens adjusted accordingly to meet the LDL-C targets.
|
Patients in this group will receive treatment regimens adjusted accordingly to meet the LDL-C targets.
|
|
Experimental: ApoB-guided-LLT
Patients in this group will receive treatment regimens adjusted accordingly to meet the Apolipoprotein B targets.
|
Patients in this group will receive treatment regimens adjusted accordingly to meet the Apolipoprotein B targets
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Efficacy of lipid-lowering therapy predicated on target Apolipoprotein B or target Low-Density Lipoprotein Cholesterol (LDL-C) levels
Time Frame: 1 year
|
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.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
Time Frame: 1 year
|
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.
|
1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ApoBguidedLLT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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