Use of pool paclitaxel nanoemulsion lipid for treatment of coronary artery disease: a randomized, double-blind, placebo-controlled trial

Abstract

The clinical treatment of coronary artery disease (CAD) is still restricted to interventions on risk factors, reflected in the administration of statins and antiplatelet. Analyzing the strong proliferative-inflammatory component of the disease, a treatment strategy based on antiproliferative drugs such as those used in cancer treatment, can be a very promising therapeutic route, directed to the underlying disease. We have shown that, after injection into the bloodstream with lipid nanoparticles similar to that of low density lipoproteins (LDL) are concentrated in malignant tumors and other proliferative and inflammatory processes in nature, such as atherosclerosis structure. The goal of this project is to verify whether the association paclitaxel - nanoemulsion is able to modify the inflammatory profile of patients with CAD treated with the association. 40 patients with CAD confirmed by coronary angiography, between 40 and 70 years of age, of both sexes, will be evaluated, randomly allocated into two groups: A) patients treated with paclitaxel associated to the nanoemulsion (150 mg/m2 infusion EV in 4 doses with an interval of 3 weeks). B) Control group, treated with nanoemulsion without paclitaxel. Before and after the treatment, the patients will be subjected to CT angiography and vascular reactivity to assess the efficacy of treatment. Clinical and biochemical tests will be performed every 3 weeks for assessment of toxicity. Serum levels of inflammatory cytokines will be assessed every 3 weeks.