Condition category
Circulatory System
Date applied
23/10/2000
Date assigned
23/10/2000
Last edited
27/10/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.acst.org.uk/acst-1_results/index.php

Contact information

Type

Scientific

Primary contact

Miss Alison Halliday

ORCID ID

Contact details

ACST
Department of Cardiological Sciences
St George's Hospital Medical School
Cranmer Terrace
London
SW17 0RE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G9408332

Study information

Scientific title

Acronym

ACST

Study hypothesis

The aim is to determine whether CEA and BMT improve stroke-free survival time when compared to BMT alone. The trial will also help identify high-risk groups in whom the benefits of surgery and of BMT would be increased

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Carotid stenosis

Intervention

CEA and best medical treatment (BMT) vs BMT alone

Added 19/08/08: follow-up is minimum of 5 years

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Fatal and non-fatal stroke and death rates in medical treatment and surgery group versus medical treatment alone

Secondary outcome measures

Subsidiary analyses in an effort to identify high and low risk groups will include the effect of risk factors such as presence or absence of silent cerebral infarction on clinical outcome

Overall trial start date

01/04/1993

Overall trial end date

31/03/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Patients whose carotid stenosis has not caused symptoms for at least 6 months, who have no past history of ipsilateral disabling or severe contralateral stroke and have no clear indications or contraindications to carotid endarterectomy (CEA)

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

3120

Participant exclusion criteria

1. Patients with a small likelihood of worthwhile benefit e.g. those with major life-threatening disease.
2. Patients who have had recent myocardial infarct, intracerebral neoplasia or aneurysm, or restenosis of an artery following previous CEA

Recruitment start date

01/04/1993

Recruitment end date

31/03/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

ACST, Department of Cardiological Sciences
London
SW17 0RE
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

1. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15135594
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20870099

Publication citations

  1. Results

    Halliday A, Mansfield A, Marro J, Peto C, Peto R, Potter J, Thomas D, , Prevention of disabling and fatal strokes by successful carotid endarterectomy in patients without recent neurological symptoms: randomised controlled trial., Lancet, 2004, 363, 9420, 1491-1502, doi: 10.1016/S0140-6736(04)16146-1.

  2. Results

    Halliday A, Harrison M, Hayter E, Kong X, Mansfield A, Marro J, Pan H, Peto R, Potter J, Rahimi K, Rau A, Robertson S, Streifler J, Thomas D, , 10-year stroke prevention after successful carotid endarterectomy for asymptomatic stenosis (ACST-1): a multicentre randomised trial., Lancet, 2010, 376, 9746, 1074-1084, doi: 10.1016/S0140-6736(10)61197-X.

Additional files

Editorial Notes