Asymptomatic Carotid Surgery Trial 2: an international randomised trial to compare carotid endarterectomy with carotid artery stenting to prevent stroke
| ISRCTN | ISRCTN21144362 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21144362 |
| ClinicalTrials.gov number | NCT00883402 |
| Secondary identifying numbers | HTA 06/301/233 |
- Submission date
- 11/05/2006
- Registration date
- 03/07/2006
- Last edited
- 04/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
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 January 2026
Who is funding the study?
Health Technology Assessment Programme (UK)
Who is the main contact?
Prof. Alison Halliday
acst@nds.ox.ac.uk
Contact information
Scientific
University of Oxford
Richard Doll Building
Old Road Campus
Roosevelt Drive
Oxford
OX3 7LF
United Kingdom
 ORCID ID |
0000-0001-9828-3579 |
|---|---|
| Phone | +44 (0)1865 617979 |
| acst@nds.ox.ac.uk |
Study information
| Study design | International randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information can be found at: https://acst-2.org/Patient%20Information/Patient%20Information%20Leaflet.html |
| Scientific title | Asymptomatic Carotid Surgery Trial 2: an international randomised trial to compare carotid endarterectomy with carotid artery stenting to prevent stroke |
| Study acronym | ACST-2 |
| Study objectives | 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 |
| Ethics approval(s) | Ethics approval for the lead centre (St George's, University of London): Hertfordshire 1 Ethics Committee, 11/10/2005, ref: 05/Q0201/66 All other centres have obtained ethics approval before recruitment of the first participant |
| Health condition(s) or problem(s) studied | Stroke caused by stenosis in the carotid arteries |
| Intervention | Carotid endarterectomy versus carotid artery stenting |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 study start date | 01/04/2007 |
| Completion date | 01/01/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | At least 5000 patients |
| Total final enrolment | 3625 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2007 |
| Date of final enrolment | 28/01/2021 |
Locations
Countries of recruitment
- Belgium
- Bulgaria
- Canada
- China
- Czech Republic
- Egypt
- England
- 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
Study participating centre
OX3 9DU
United Kingdom
Sponsor information
University/education
Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
England
United Kingdom
| Phone | +44 (0)1865 221 345 |
|---|---|
| Richard.Liwicki@admin.ox.ac.uk | |
| Website | http://www.admin.ox.ac.uk/rso/contactus/ctrg.shtml |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/08/2009 | Yes | No | |
| Results article | results | 01/11/2013 | Yes | No | |
| Results article | 27/08/2021 | 02/09/2021 | Yes | No |
Editorial Notes
04/04/2025: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2019 to 28/01/2021.
2. The overall end date was changed from 31/12/2019 to 01/01/2026.
3. The plain English summary was updated to reflect these changes.
02/09/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
16/03/2016: Plain English summary added.
09/12/2014: The overall trial end date was changed from 31/03/2012 to 31/12/2019.
02/09/2009: The sponsor was changed from St. George's University of London to University of Oxford.
