Efficacy of Lipid-Lowering Therapy Based on Apolipoprotein B Versus LDL-Cholesterol Levels in Patients Undergoing Percutaneous Coronary Intervention: a Multicenter, Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 1,448
- Locations
- 2
- Primary Endpoint
- Efficacy of lipid-lowering therapy predicated on target Apolipoprotein B or target Low-Density Lipoprotein Cholesterol (LDL-C) levels
Study Overview
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:
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.).
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)(1 year)
Investigators
Vu Hoang Vu
Head of Interventional Cardiology Department, PhD MD
University of Medicine and Pharmacy at Ho Chi Minh City