Trial to Evaluate the Ability of a Single Infusion of High-Density Lipoprotein (HDL) to Modulate Markers of Cerebral Ischaemia

Stroke Clinical Trial

— REVEAL  

Official title:

Does recHDL Given i.v. Before CEA Prevent Cerebral Ischaemia? - the Reveal Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00822302
• Other study ID #: Eudract Nos: 2008-000093-21
• Secondary ID: DTX/DDX number:M
• Status: Completed
• Phase: N/A
• First received: January 13, 2009
• Last updated: June 5, 2015
• Start date: February 2006
• Est. completion date: February 2009

Study information

• Verified date: January 2009
• Source: St George's, University of London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Description:

Following written informed consent, patients will be randomised to either the placebo or active arm of the study. Bloods will be taken for baseline measurements, and the infusion of either saline (placebo) or rHDL (active agent) will be carried out on the ward. Infusion will take 4 hours, and the active agent infused at 40mg/kg.

Just prior to CAE, bloods will be collected (24 hours post-infusion) and the atherosclerotic tissue collected into RNA stabilising agent for subsequent analysis. Further bloods will then be collected 24 hours post-operatively (48 hours post-infusion).

Patients vital signs will be monitored hourly following infusion and will be reviewed in out-patients at 6 weeks after the operation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients listed for elective carotid endarterectomy

Exclusion Criteria:

• pregnant women and women of childbearing age

• patient with impaired renal function or liver function

• patients sectioned under the Mental Health Act

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cerebral Infarction
• Stroke

Intervention

Drug:
• Reconstituted High Density Lipoprotein
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.
• Saline
Saline (0.9%) is provided as a sterile infusion bag and infused over a period of 4 hours, 24 hours prior to carotid endarterectomy

Locations

Country	Name	City	State
United Kingdom	St Georges University of London	London	Tooting

Sponsors (1)

Lead Sponsor	Collaborator
St George's, University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory and thrombotic response		baseline, 24 hours after infusion, 48 hours after infusion	No