Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001207808
Ethics application status
Not yet submitted
Date submitted
14/11/2012
Date registered
15/11/2012
Date last updated
27/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does Administration of Recombinant Lecithin:Cholesterol Acyl Transferase (rLCAT) Lead To Reduction in Inflammatory Markers and Changes in Plaque Composition and Cell Cholesterol Content in Patients With Peripheral Vascular Disease
Scientific title
Does Administration of Recombinant Lecithin:Cholesterol Acyl Transferase (rLCAT) Lead To Reduction in Inflammatory Markers and Changes in Plaque Composition and Cell Cholesterol Content in Patients With Peripheral Vascular Disease
Secondary ID [1] 281541 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Vascular Disease 287805 0
Atherosclerosis 287806 0
Hypercholesterolemia 287807 0
Condition category
Condition code
Cardiovascular 288168 288168 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ACP-501 Recombinant Lecithin:Cholesterol Acyl Transferase (rLCAT)

Dose Administered : Single dose at 9mg/kg
Mode of Administration : Intravenously infused over 4 hours
Intervention code [1] 286054 0
Treatment: Drugs
Comparator / control treatment
Placebo treatment will be used (saline)
Control group
Placebo

Outcomes
Primary outcome [1] 288359 0
Primary Outcome : By using atherectomy catheters, plaques will be extracted from arteries of patients. Cholesterol content in these plaques will be analyzed. Cohorts receiving rLCAT will be compared to controls.

Tests used : Freezing sections in OCT compound, sectioning and subsequently staining with oil red O to study lipid content.
Timepoint [1] 288359 0
Primary Timepoint : Post infusion of rLCAT
Primary outcome [2] 288362 0
Primary Outcome : Blood will be collected pre- and post- infusion of rLCAT. Changes in fasting lipid profile and inflammatory markers will be compared. Cohorts receiving rLCAT will be compared to controls.

Test used : We will use COBAS to look at lipid profiles. Inflammatory markers will be assessed by using ELSA kits.
Timepoint [2] 288362 0
Primary Timepoint : Pre and Post infusion of rLCAT
Secondary outcome [1] 299962 0
Secondary Outcome : From blood collected, we can determine the effects of rLCAT on existing LCAT levels in patients and (if possible) look at pharmacodynamics and pharmacokinetics of rLCAT as well.

Test used : LCAT will be assessed by using ELSA kits.
Timepoint [1] 299962 0
Secondary Timepoints : Pre and Post infusion of rLCAT
Secondary outcome [2] 299984 0
Secondary Outcome : From blood collected, we can determine the change, if any, in functionality of HDL by observing cholesterol efflux.

Test used : In-house in vitro system where plasma is incubated with cells containing labelled cholesterol.
Timepoint [2] 299984 0
Secondary Timepoints : Pre and Post infusion of rLCAT

Eligibility
Key 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
Minimum age
40 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/07/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 286321 0
Government body
Name [1] 286321 0
NHMRC
Country [1] 286321 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
AlphaCore Pharma
Address
AlphaCore Pharma
333 Parkland Plaza
Suite 5
Ann Arbor, MI 48103
Country
United States of America
Secondary sponsor category [1] 285109 0
Hospital
Name [1] 285109 0
Alfred Hospital
Address [1] 285109 0
Commercial Road
Melbourne VIC 3004
Country [1] 285109 0
Australia
Other collaborator category [1] 277173 0
Other Collaborative groups
Name [1] 277173 0
Baker IDI Heart and Diabetes Institute
Address [1] 277173 0
75 Commercial Road
Melbourne VIC 3004
Country [1] 277173 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288392 0
Ethics committee address [1] 288392 0
Ethics committee country [1] 288392 0
Date submitted for ethics approval [1] 288392 0
31/10/2012
Approval date [1] 288392 0
Ethics approval number [1] 288392 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34951 0
Prof Dmitri Sviridov
Address 34951 0
75 Commercial Road
Melbourne VIC 3004
Country 34951 0
Australia
Phone 34951 0
+61385321363
Fax 34951 0
Email 34951 0
[email protected]
Contact person for public queries
Name 18198 0
Dr Dr. James Shaw
Address 18198 0
Alfred Hospital
Commercial Road
Melbourne VIC 3004
Country 18198 0
Australia
Phone 18198 0
+613 9076 2257
Fax 18198 0
Email 18198 0
[email protected]
Contact person for scientific queries
Name 9126 0
Mr Hann Low
Address 9126 0
Baker IDI Heart and Diabetes Institute
75 Commercial Road
Melbourne VIC 3004
Country 9126 0
Australia
Phone 9126 0
+613 8532 1306
Fax 9126 0
Email 9126 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.