Randomized Controlled Trial Assessing the Efficacy and Safety of a Liposomal Carrier for Low-Dose Dual Antiplatelet Therapy (Clopidogrel and Aspirin) in Coronary Heart Disease Patients

Abstract

Background

Coronary heart disease (CHD) is a leading cause of global mortality, and antiplatelet drugs are crucial in its treatment. Traditional therapy, however, often faces issues like inconsistent efficacy, frequent dosing, and high complication rates.

Purpose

This study aimed to develop a liposomal carrier for low-dose dual antiplatelet drugs (clopidogrel and aspirin) using nanotechnology and evaluate its efficacy and safety in CHD patients.

Methods

The study first prepared drug carriers for clopidogrel and aspirin using a liposomal approach, and the characteristics and in vitro drug release properties of these carriers were evaluated using various techniques. Subsequently, a randomized controlled trial was conducted with 270 patients diagnosed with CHD, who were divided into the control group (receiving 75 mg of clopidogrel and 100 mg of aspirin daily) and the treatment group (receiving the same regimen as the control group, with the addition of a nanoparticle drug delivery system), with 135 patients in each group. The efficacy and safety of the two interventions were then evaluated.

Findings

The liposomal carriers demonstrated high drug encapsulation efficiency and sustained release. Clinical trials showed superior efficacy and fewer complications with the nanoparticle drug delivery system compared to traditional antiplatelet therapy.

Implications

The nanoparticle drug delivery system for low-dose dual antiplatelet drugs shows promise as a novel therapeutic strategy for CHD patients. Further validation through larger sample sizes and long-term follow-up studies is necessary.