Condition category
Circulatory System
Date applied
11/05/2006
Date assigned
03/07/2006
Last edited
16/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Stroke causes about 10% of all deaths worldwide, and much serious disability. Many strokes are caused by thick fatty deposits narrowing the carotid arteries, which are the main blood vessels in the neck that supply blood to the brain. People with this condition, called carotid artery stenosis, may have no symptoms from it (i.e., they are asymptomatic) until fragments of the deposits fall off, lodge in the brain and cause a major stroke. The standard operation to prevent this, carotid endarterectomy (CEA), involves surgical removal of the deposits before they cause a stroke. It involves some immediate risk but if successful, confers long-term protection. An alternative technique is carotid artery stenting (CAS), which involves placing a fine scaffolding (stent) inside the narrowed artery to hold it open indefinitely. The aim of this study is to compare the immediate risks and long-term benefits of CAS and CEA for the prevention of stroke.

Who can participate?
Asymptomatic carotid artery stenosis patients in need of some type of carotid artery treatment, but with substantial uncertainty about whether to treat with CEA or CAS.

What does the study involve?
Participants are randomly allocated to be treated with either CEA or CAS, and we compare the immediate hazards (mainly heart attack, stroke or death) and the stroke risks over the next few years. The type and severity of any strokes is also assessed.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
University of Oxford (UK)

When is the study starting and how long is it expected to run for?
April 2007 to December 2019

Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK)

Who is the main contact?
Prof Alison Halliday
acst@nds.ox.ac.uk

Trial website

http://www.acst.org.uk

Contact information

Type

Scientific

Primary contact

Prof Alison Halliday

ORCID ID

Contact details

University of Oxford
Level 6
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 221 345
acst@nds.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00883402

Protocol/serial number

HTA 06/301/233

Study information

Scientific title

Asymptomatic Carotid Surgery Trial 2: an international randomised trial to compare carotid endarterectomy with carotid artery stenting to prevent stroke

Acronym

ACST-2

Study hypothesis

To compare:
1. The peri-procedural risks (within 30 days) of carotid endarterectomy (CEA) or carotid artery stenting (CAS)
2. The long-term (5-year) prevention of stroke and of disabling or fatal stroke

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/06301233
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0013/51304/PRO-06-301-233.pdf

Ethics approval

Ethics approval for the lead centre (St George's, University of London): Hertfordshire 1 Ethics Committee, approved on 11/10/2005, ref: 05/Q0201/66. All other centres have obtained ethics approval before recruitment of the first participant

Study design

International randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information can be found at: http://www.nds.ox.ac.uk/acst/collaborators-information/study-documentation

Condition

Stroke caused by stenosis in the carotid arteries

Intervention

Carotid endarterectomy versus carotid artery stenting

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. Peri-procedural hazards (within 30 days) stroke, myocardial infarction and death
2. Long-term hazards (after 30 days) stroke and death

Secondary outcome measures

Cost-effectivness of CEA and CAS

Overall trial start date

01/04/2007

Overall trial end date

31/12/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patient in need of some type of carotid artery intervention, with substantial uncertainty about whether to treat with CEA or CAS
2. Carotid artery stenosis with no ipsilateral carotid territory symptoms within the last 6 months
3. Patient fit and willing for follow-up

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

At least 5000 patients

Participant exclusion criteria

1. Previous CEA or CAS in randomised artery
2. High risk of adverse events of trial treatment e.g. inaccessible stenosis
3. Small likelihood of worthwhile benefit e.g. low risk of stroke
4. Patient unable or unwilling to give informed consent

Recruitment start date

01/04/2007

Recruitment end date

31/12/2019

Locations

Countries of recruitment

Belgium, Bulgaria, Canada, China, Czech Republic, Egypt, Estonia, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Kazakhstan, Netherlands, Norway, Poland, Russian Federation, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom, United States of America

Trial participating centre

University of Oxford
Oxford
OX3 9DU
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 221 345
Richard.Liwicki@admin.ox.ac.uk

Sponsor type

University/education

Website

http://www.admin.ox.ac.uk/rso/contactus/ctrg.shtml

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

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

2009 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19540137
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24051108

Publication citations

  1. Protocol

    Rudarakanchana N, Dialynas M, Halliday A, Asymptomatic Carotid Surgery Trial-2 (ACST-2): rationale for a randomised clinical trial comparing carotid endarterectomy with carotid artery stenting in patients with asymptomatic carotid artery stenosis., Eur J Vasc Endovasc Surg, 2009, 38, 2, 239-242, doi: 10.1016/j.ejvs.2009.05.010.

  2. Results

    , Halliday A, Bulbulia R, Gray W, Naughten A, den Hartog A, Delmestri A, Wallis C, le Conte S, Macdonald S, Status update and interim results from the asymptomatic carotid surgery trial-2 (ACST-2)., Eur J Vasc Endovasc Surg, 2013, 46, 5, 510-518, doi: 10.1016/j.ejvs.2013.07.020.

Additional files

Editorial Notes

16/03/2016: Plain English summary added. On 09/12/2014 the overall trial end date was changed from 31/03/2012 to 31/12/2019. Please note that the sponsor details have been updated as of 02/09/2009. Previous details: St. George's University of London (UK) St. George's Research Office Ground Floor Hunter Wing Cranmer Terrace Tooting London SW17 0RE United Kingdom Tel: +44 (0)208 725 1012 Fax: +44 (0)208 725 3426 Email: doliveir@sgul.ac.uk http://www.sgul.ac.uk The current details can be found in the sponsor section.