Efficacy of Lipid-Lowering Therapy Based on Apolipoprotein B Versus LDL-Cholesterol Levels in Patients Undergoing Percutaneous Coronary Intervention
ApoB-guidedLLT
1 other identifier
interventional
1,448
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2024
CompletedFirst Posted
Study publicly available on registry
October 3, 2024
CompletedStudy Start
First participant enrolled
January 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2029
October 16, 2024
September 1, 2024
3 years
October 1, 2024
October 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
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
Study Arms (2)
LDL-C guided-LLT
ACTIVE COMPARATORPatients in this group will receive treatment regimens adjusted accordingly to meet the LDL-C targets.
ApoB-guided-LLT
EXPERIMENTALPatients in this group will receive treatment regimens adjusted accordingly to meet the Apolipoprotein B targets.
Interventions
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 LDL-C targets.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medical Center Ho Chi Minh City
Ho Chi Minh City, 700000, Vietnam
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Interventional Cardiology Department, PhD MD
Study Record Dates
First Submitted
October 1, 2024
First Posted
October 3, 2024
Study Start
January 1, 2025
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
January 1, 2029
Last Updated
October 16, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share