None listed
Conditions
Brief summary
The purpose of this study is to determine whether rLCAT, when given to patients can lead to changes in the composition of plaque in the leg arteries and to changes in the amount of cholesterol and inflammation in the blood. From laboratory studies, rLCAT shows promising outcomes in terms of its ability to remove cholesterol from cells and animal models. Hence, we hypothesize it will have a similar effect in patients.
Interventions
ACP-501 Recombinant Lecithin:Cholesterol Acyl Transferase (rLCAT)
Dose Administered : Single dose at 9mg/kg
Mode of Administration : Intravenously infused over 4 hours
Sponsors
AlphaCore Pharma
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Patients with claudication and evidence on testing including ABI <0.9 and ultrasound imaging of the superficial femoral artery, to have sfa disease amenable to percutaneous revascularisation Serum HDL < 1.0 mmol/l
Exclusion criteria
Exclusion Criteria AMI or presentation with unstable angina within 1 month of enrolment Serum creatinine > 0.2mmol/l Pregnancy or chance of being pregnant Unable to give informed consent Significant co-morbidity with expected survival < 6 months Known allergy to immunoglobulin Patients with chronic liver disease Patients on anticoagulants
Outcome results
None listed