Plain English Summary

Not provided at time of registration

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)

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. 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. The results will be used to inform patients and doctors choosing which treatment plan is the safest and most effective for individual patients.

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

GP practices

Trial type

Not Specified

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 threapy.

Intervention type

Other

Phase

Not Applicable

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 & 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
+44 (0) 20 7679 2000

Sponsor type

University/education

Website

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

Funders

Funder type

Government

Funder name

National Institute of Health Research (NIHR) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Editorial Notes