Treatment of Patients With Atherosclerotic Disease With Paclitaxel-associated to LDL Like Nanoparticles

• Status: Active, not recruiting
• Trial end date: 2021-08-23
• Target enrollment: 0
• Participant gender: All

Summary

The investigators propose a prospective, randomized, double-blind, placebo-controlled study. The purpose of the study is to evaluate the safety and efficacy of an anti-proliferative agent paclitaxel in a cholesterol-rich non-protein nanoparticle (Paclitaxel -LDE) in patients with stable coronary disease.

Patients with multi-vessels stable coronary disease will be randomized to receive Paclitaxel-LDE IV or placebo-LDE IV each 21 days for 6 weeks. The primary and main secondary endpoints will be analyzed by coronary and aortic CTA, that will be performed 1-4 weeks after randomization and at 3-8 weeks after the last treatment cycle.

Patients will undergo clinical and laboratory safety evaluations before each treatment cycle and 3-8 weeks after the last cycle. An algorithm for drug suspension based on clinical and laboratory finding will be followed.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo General Hospital
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

• Multi-vessels coronary artery disease diagnosis by coronary CTA scan or invasive angiography

• Aortic atherosclerosis diagnosis by multidetector computed tomography (MDCT) angiography.

• Signing the study informed consent.

Exclusion Criteria:

• History of AMI in the last 30 days

• Heart failure with ejection fraction <40%

• Estimated glomerular filtration rate < 40 mL/min/1.73 m2.

• Prior history of chronic infectious disease, including tuberculosis, severe fungal disease, or known HIV positive.

• Chronic hepatitis B or C infection.

• Prior history of nonbasal cell malignancy or myeloproliferative or lymphoproliferative disease within the past 5 years.

• White blood cell count <4000/mm3, hematocrit <32%, or platelet count <75000/mm3.

• Alanine aminotransferase levels (ALT) greater than 3-fold the upper limit of normal.

• History of actual alcohol abuse or unwillingness to limit alcohol consumption to < 4 drinks per week.

• Pregnancy or breastfeeding.

• Women of child bearing potential, even if currently using contraception.

• Men who plan to father children during the study period or who are unwilling to use contraception.

• Chronic use of oral steroid therapy or other immunosuppressive or biologic response modifiers.

• Known chronic pericardial effusion, pleural effusion, or ascites.

• Angina pectoris CCS III-IV

• New York Heart Association class III-IV congestive heart failure.

• Contraindication for the use of iodinated contrast

• Life expectancy of < 1 years.

• Acute or Chronic aortic dissection