Condition category
Circulatory System
Date applied
05/07/2012
Date assigned
05/07/2012
Last edited
11/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Atherosclerotic carotid stenosis is a narrowing of the carotid artery in the neck by fatty deposits. It is an important cause of stroke, and hence disability and premature death. Previous studies have shown that an operation to remove the narrowing, known as carotid endarterectomy (CEA), is more effective than treatment with tablets to prevent stroke. In some patients a treatment called stenting may be as effective as surgery. Stenting involves a wire mesh tube being inserted via an artery in the groin and opened up across the narrowing in the neck. However, drug treatment has improved since the original studies of surgery. We think medical treatment is now so effective that the benefits of removing the narrowing may not justify the risk of surgery or stenting in patients with a lower risk of stroke, such as those who have had no symptoms for some months or never had symptoms from the narrowing. The aim of this study is to determine whether these patients should be managed by drug treatment alone or should still be referred for surgery or stenting.

Who can participate?
Patients over 18 years of age with atherosclerotic carotid stenosis and at a lower risk of stroke.

What does the study involve?
Participants have their medication adjusted to reach the recommended levels for cholesterol and blood pressure, and receive advice about healthy lifestyle. Half of the patients are randomly allocated to have surgery or stenting as soon as possible, and the other half continue on medical treatment alone until such time, if ever, that revascularisation surgery becomes clearly indicated. Participants are seen regularly for several years to check their cholesterol and blood pressure remain on target and to record any surgical complications and the occurrence of strokes or heart attacks.

What are the possible benefits and risks of participating?
The results will be used to help patients and doctors to choose which treatment plan is the safest and most effective.

Where is the study run from?
The National Hospital for Neurology and Neurosurgery (UK)

When is the study starting and how long is it expected to run for?
March 2012 to March 2022

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Mr Roland Featherstone
r.featherstone@ion.ucl.ac.uk

Trial website

http://www.ecst-2.com/

Contact information

Type

Scientific

Primary contact

Mr Roland Featherstone

ORCID ID

Contact details

The National Hospital for Neurology and Neurosurgery
Queen Square
London
WC1N 3BG
United Kingdom
-
r.featherstone@ion.ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11034

Study information

Scientific title

European Carotid Surgery Trial 2 (ECST-2): a randomised controlled trial

Acronym

ECST 2

Study hypothesis

Narrowing of the carotid artery in the neck by fatty deposits is an important cause of stroke, and hence disability and premature death. Previous trials have shown that an operation to remove the narrowing, known as carotid endarterectomy (CEA), is more effective than treatment with tablets to prevent stroke. In some patients a treatment called stenting where a wire mesh tube is inserted via an artery in the groin and opened up across the narrowing in the neck may be as effective as surgery. However, drug therapy has improved since the original trials of surgery. We think medical therapy is now so effective that the benefits of removing the narrowing may not justify the risk of surgery or stenting in patients with a lower risk of stroke e.g. those who have had no symptoms for some months from the narrowing or never had symptoms. We propose a clinical trial to determine whether these patients should be managed by drug therapy alone or should still be referred for surgery or stenting.

More details can be found at http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=11034

Ethics approval

ref: 11/EE/0347

Study design

Randomised controlled interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Stroke

Intervention

Immediate endartorectomy and optimised medical therapy.

All patients will have their medication adjusted to reach recommended levels for cholesterol and blood pressure, and receive advice about healthy lifestyle. Half the patients will be randomly allocated to have surgery or stenting as soon as possible, the other half will continue on medical treatment alone until such time, if ever, that revascularisation becomes clearly indicated. Patients will be seen regularly for several years to check their cholesterol and blood pressure remain on target and to record surgical complications and the occurrence of strokes or heart attacks. An interim safety analysis will be performed using MRI follow up to assess rates of new cerebral infarction and haemorrhage.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Any stroke at any time + non-stroke death within 30 days of endartorectomy

Secondary outcome measures

No secondary outcome measures

Overall trial start date

23/03/2012

Overall trial end date

31/03/2022

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients over 18 years of age with atherosclerotic carotid stenosis equivalent to at least 50% measured using the North American Symptomatic Carotid Endarterectomy Trial (NASCET) method
2. Patient is medically and neurologically stable and suitable for CEA or carotid artery stenting (CAS)
3. Patients with a carotid artery risk (CAR) score indicating a 5-year ipsilateral stroke risk of <20%. This may include patients with asymptomatic stenosis or symptomatic stenosis associated with features (e.g. delayed presentation) indicating intermediate or lower risk, confirmed by CAR Score <20%
4. Clinicians are uncertain about which treatment modality is best for the individual patient
5. Patient or appropriate representative is able and willing to give informed consent
6. Male and female participants

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 200

Participant exclusion criteria

1. Patients (or their representatives) unwilling to have either treatment modality
2. Patients unwilling or unable to participate in follow up for whatever reason
3. Patients with a Rankin score greater than 3 for any reason. Such patients may be eligible for inclusion at such time as they improve to a Rankin score of 3 or less
4. Patients who are medically or neurologically unstable or have progressing neurological signs. Such patients may be eligible for inclusion at such time as they become stable
5. Patients in whom it is planned to carry out coronary artery bypass grafting or other major surgery within one month of carotid stenting or endarterectomy
6. Patients with a CAR Score >20% or other reason for believing the patient would get clear benefit from CEA or CAS
7. Patients not suitable for either surgery or stenting due to anatomical factors
8. Carotid stenosis caused by nonatherosclerotic disease e.g. dissection, fibromuscular disease or neck radiotherapy
9. Previous CEA or stenting in the randomised artery
10. Patients who are known to be pregnant
11. Patients who have a life expectancy of less than two years due to a preexisting condition e.g. cancer
12. Patients intolerant or allergic to all of the medications available for optimised modern medical therapy
13. Patients in clinical trials of medicinal products (CTIMPS) or who have been in a CTIMP within the last 4 months will not be enrolled
14. Patients in other trials (both stroke related and non stroke related) may be enrolled where this would not conflict with the treatments used in ECST2 or place undue additional burdens on the patient

Recruitment start date

23/03/2012

Recruitment end date

31/03/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The National Hospital for Neurology and Neurosurgery
London
WC1N 3BG
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

Institute of Neurology
Queen Square
London
WC1N 3BG
United Kingdom

Sponsor type

University/education

Website

http://www.ucl.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

11/02/2016: Plain English summary added.