Efficacy of Lipid-Lowering Therapy Based on Apolipoprotein B Versus LDL-Cholesterol Levels in Patients Undergoing Percutaneous Coronary Intervention

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medical Center Ho Chi Minh City (UMC)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ApoB-guided-LLT

    Other intervention

    Patients in this group will receive treatment regimens adjusted accordingly to meet the Apolipoprotein B targets

  • LDL-C-guided-LLT

    Other intervention

    Patients in this group will receive treatment regimens adjusted accordingly to meet the LDL-C targets.

Treatment groups

1,448 Participants
are divided into 2 treatment groups
Group A: LDL-C guided-LLTActive comparator 1 intervention
Group B: ApoB-guided-LLTExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
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)

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.

Time frame
1 year

Other outcomes

Sponsors and contacts

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University Medical Center Ho Chi Minh City (UMC)

Lead sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Sponsor institution

University of Medicine and Pharmacy at Ho Chi Minh City

Collaborator

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