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02 September 2010
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| Asymptomatic Carotid Surgery Trial-2: an international randomised trial to compare carotid endarterectomy with carotid artery stenting to prevent stroke |
| ISRCTN | ISRCTN21144362 |
| ClinicalTrials.gov identifier | NCT00883402 |
| Public title | Asymptomatic Carotid Surgery Trial-2: an international randomised trial to compare carotid endarterectomy with carotid artery stenting to prevent stroke |
| Scientific title | |
| Acronym | ACST-2 |
| Serial number at source | HTA 06/301/233 |
| 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 (five-year) prevention of stroke and of disabling or fatal stroke |
| 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 |
| Countries of recruitment | International |
| Disease/condition/study domain | Stroke caused by stenosis in the carotid arteries |
| Participants - 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 six months 3. Patient fit and willing for follow-up |
| Participants - 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 |
| Anticipated start date | 01/04/2007 |
| Anticipated end date | 31/03/2012 |
| Status of trial | Ongoing |
| Patient information material | Patient information leaflet can be found within the protocol at: http://www.acst.org.uk |
| Target number of participants | At least 5000 patients |
| Interventions |
Carotid endarterectomy versus carotid artery stenting
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 below. |
| Primary outcome measure(s) |
1. Peri-procedural hazards (within 30 days) stroke, myocardial infarction and death
2. Long-term hazards (after 30 days) stroke and death |
| Secondary outcome measure(s) | Cost-effectivness of CEA and CAS |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Trial website | http://www.acst.org.uk |
| Publications | |
| Contact name | Prof Alison Halliday |
| Address |
St. George's University of London
Division of Cardiac and Vascular Sciences Cranmer Terrace |
| City/town | London |
| Zip/Postcode | SW17 0RE |
| Country | United Kingdom |
| Tel | +44 (0)208 725 3746 |
| Fax | +44 (0)208 725 3782 |
| acst@sgul.ac.uk | |
| Sponsor | University of Oxford (UK) |
| Address |
Clinical Trials and Research Governance
Manor House John Radcliffe Hospital Headington |
| City/town | Oxford |
| Zip/Postcode | OX3 9DU |
| Country | United Kingdom |
| Tel | +44 (0)1865 743003 |
| Fax | +44 (0)1865 743002 |
| Richard.Liwicki@admin.ox.ac.uk | |
| Sponsor website: | http://www.admin.ox.ac.uk/rso/contactus/ctrg.shtml |
| Date applied | 11/05/2006 |
| Last edited | 05/10/2009 |
| Date ISRCTN assigned | 03/07/2006 |
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