Clinical trial NCT06626126: Efficacy of Lipid-Lowering Therapy Based on Apolipoprotein B Versus LDL-Cholesterol Levels in Patients Undergoing Percutaneous Coronary Intervention
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Arterial Disease (CAD)
Percutaneous Coronary Intervention
LDL-cholesterol
Lipid Metabolism Disorders
Keywords: ApoB-guidedLLT
PCI
Coronary artery disease
lipid lowering therapy
Lead sponsor: University Medical Center Ho Chi Minh City (UMC)
Sponsor class: OTHER
Collaborators: name: University of Medicine and Pharmacy at Ho Chi Minh City
First posted: 2024-10-03
Enrollment: 1448
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 \&amp;amp;lt; 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

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.

Eligibility criteria: Inclusion Criteria:

1. Patients aged 18 years or older.
2. Patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES).
3. Patients who agree to participate and provide informed consent.

Exclusion Criteria:

1. Inability to Provide Informed Consent: Patients who are unable or unwilling to provide consent.
2. Limited life expectancy: patients with a life expectancy of less than 12 months due to other non-cardiac conditions.
3. Liver Disease: patients with cirrhosis or significant liver dysfunction.
4. Patients with contraindication to statin or other lipid-lowering therapy.
5. 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.).

Primary outcomes:
measure: Efficacy of lipid-lowering therapy predicated on target Apolipoprotein B or target Low-Density Lipoprotein Cholesterol (LDL-C) levels
timeFrame: 1 year
Secondary outcomes:
measure: 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)
timeFrame: 1 year
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: University Medical Center Ho Chi Minh City
Study officials:
References: