NCT00822302

Brief Summary

The plasma concentration of high-density lipoprotein (HDL) can have anti-inflammatory, anti-oxidative and anti-thrombotic effects in addition to being able to remove cholesterol from peripheral tissues for secretion via the liver. The investigators hypothesise that elevation of plasma HDLs will reduce the inflammatory response following removal of unstable atherosclerotic plaques in the carotid artery. Such plaques can cause strokes and there is great benefit from early surgical removal, however such surgical procedures involve significant risks to the patient. The investigators propose infusing HDL into patients prior to removal of their unstable carotid plaque and measuring the changes in inflammatory responses in comparison to a similar placebo controlled group of patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Feb 2006

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2009

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

June 9, 2015

Status Verified

January 1, 2009

Enrollment Period

2.8 years

First QC Date

January 13, 2009

Last Update Submit

June 5, 2015

Conditions

Stroke

Keywords

atherosclerosisstrokeischaemia

Outcome Measures

Primary Outcomes (1)

  • Inflammatory and thrombotic response

    baseline, 24 hours after infusion, 48 hours after infusion

Study Arms (2)

1.Saline Infusion

PLACEBO COMPARATOR

Patients randomised to this arm will receive an infusion of saline

Drug: Saline

2.recHDL

ACTIVE COMPARATOR

Patients randomised to the active comparator arm of the study will receive 40mg/kg reconstituted High density lipoproteins (lot nos 05422-00006) over a period of 4 hours, 24 hours prior to carotid endarterectomy.

Drug: Reconstituted High Density Lipoprotein

Interventions

Reconstituted High Density LipoproteinDRUG

RecHDL (Lot Nos 05422-00006)is provided as a lyophilised powder and reconstituted with sterile water at 25 mg/ml. The infusion is made at 40 mg/kg over a period of 4 hours.

Also known as: rHDL, discoidal HDL
2.recHDL
SalineDRUG

Saline (0.9%) is provided as a sterile infusion bag and infused over a period of 4 hours, 24 hours prior to carotid endarterectomy

Also known as: normal saline
1.Saline Infusion

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients listed for elective carotid endarterectomy

You may not qualify if:

  • pregnant women and women of childbearing age
  • patient with impaired renal function or liver function
  • patients sectioned under the Mental Health Act

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Georges University of London

London, Tooting, SW17 0QT, United Kingdom

Location

MeSH Terms

Conditions

StrokeAtherosclerosisIschemia

Interventions

High-Density Lipoproteins, Pre-betaSodium ChlorideSaline Solution

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lipoproteins, HDLLipoproteinsLipidsProteinsAmino Acids, Peptides, and ProteinsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2009

First Posted

January 14, 2009

Study Start

February 1, 2006

Primary Completion

December 1, 2008

Study Completion

February 1, 2009

Last Updated

June 9, 2015

Record last verified: 2009-01

Locations

GB(1)