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| Name | Class |
|---|---|
| University of Medicine and Pharmacy at Ho Chi Minh City | OTHER |
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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.
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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDL-C guided-LLT | Active Comparator | Patients in this group will receive treatment regimens adjusted accordingly to meet the LDL-C targets. |
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| ApoB-guided-LLT | Experimental | Patients in this group will receive treatment regimens adjusted accordingly to meet the Apolipoprotein B targets. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ApoB-guided-LLT | Other | Patients in this group will receive treatment regimens adjusted accordingly to meet the Apolipoprotein B targets |
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of lipid-lowering therapy predicated on target Apolipoprotein B or target Low-Density Lipoprotein Cholesterol (LDL-C) levels | 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 |
| 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) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vu Hoang Vu, Ph.D M.D | Contact | +84908431304 | vu.vh@umc.edu.vn | |
| Bao Thien Duong, M.D | Contact | +84936287137 | bao.dt1@umc.edu.vn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Ho Chi Minh City | Ho Chi Minh City | 700000 | Vietnam |
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| LDL-C-guided-LLT | Other | Patients in this group will receive treatment regimens adjusted accordingly to meet the LDL-C targets. |
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| 1 year |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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