Condition category
Circulatory System
Date applied
08/09/2006
Date assigned
10/11/2006
Last edited
06/04/2011
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.scast.no

Contact information

Type

Scientific

Primary contact

Dr Eivind Berge

ORCID ID

Contact details

Department of Internal Medicine
Ullevaal University Hospital
Kirkeveien 166
Oslo
NO-0407
Norway
+47 22 11 91 01
eivind.berge@medisin.uio.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00120003

Protocol/serial number

Version/Date 050708

Study information

Scientific title

Acronym

SCAST

Study hypothesis

The Angiotensin Type 1 (AT1) receptor blockade with candesartan in acute stroke will:
1. Reduce the risk of death or major disability at six months by a 6% absolute risk reduction, relative to placebo
2. Reduce the risk of the combined event of 'vascular' death, myocardial infarction, or stroke during the first six months by a 25% relative risk reduction, relative to placebo

Ethics approval

Ethics approval received from the local medical ethics committees of :
1. Norway: 21st December 2004 (ref: 700-04250)
2. Sweden: 9th March 2005 (ref: 2005:040)
3. Denmark: 14th March 2005 (ref: 02258454)
4. Belgium: 23rd November 2005 (ref: ML3286)

Study design

Multicentre, randomised- and placebo-controlled, double blind study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Acute stroke

Intervention

Candesartan or matching placebo for seven days (4 - 16 mg)

Intervention type

Drug

Phase

Not Specified

Drug names

Candesartan

Primary outcome measures

1. Death or major disability (defined by the modified Rankin Scale) at six months
2. The composite event “vascular” death, myocardial infarction, or stroke during the first six months

Secondary outcome measures

Clinical outcomes:
1. Scandinavian Stroke Scale score at seven days
2. Modified Rankin Scale score at seven days and one, three and six months
3. Barthel Index score at six months
4. EuroQol instrument score at six months
5. Mini-Mental State score at six months

Adverse events:
During the six months’ follow-up period:
1. Death (all-cause death and “vascular” death)
2. Recurrent stroke (ischaemic, haemorrhagic, or unspecified)
3. Myocardial infarction
4. Combination of the above events
5. Other adverse events: neurological deterioration, symptomatic hypotension, renal failure, symptomatic venous thromboembolism

Health-economic measures:
Costs related to:
1. Length of hospital stay
2. Discharge disposition
3. Re-hospitalisations during the first six months

Overall trial start date

01/06/2005

Overall trial end date

01/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Clinical stroke syndrome with limb paresis, not likely to represent a transient ischaemic attack or non-stroke pathology (e.g. cerebral tumour)
2. Systolic blood pressure more than or equal to 140 mmHg
3. Trial treatment possible within 30 hours of symptom onset. If time of onset is not known, use the time when the patient was last known to be well
4. Consent (subsidiary, assent from legal acceptable representative, or waiver of consent)
5. Aged over 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2,500

Participant exclusion criteria

1. Markedly reduced consciousness (i.e. Scandinavian Stroke Scale consciousness score less than or equal to two)
2. Patient already receiving AT1 receptor blocker
3. Contraindication to treatment with AT1 receptor blocker, e.g.:
3.1. Known renal failure (women: creatinine more than or equal to 150 µmol/L; men: more than or equal to 180 µmol/L)
3.2. Previously diagnosed bilateral renal artery stenosis
3.3. Previously diagnosed high-grade aortic stenosis
3.4. Previously diagnosed seriously impaired liver function and/or cholestasis
3.5. Known intolerance to candesartan or other tablet ingredients
4. Clear indication, in the clinician’s view, for start of treatment with AT1 receptor blocker during the treatment period (e.g. chronic heart failure grade III to IV, in the presence of intolerance to Angiotensin Converting Enzyme [ACE] inhibitors)
5. Clear indication, in the clinician’s view, for anti-hypertensive therapy during the acute phase of stroke (i.e. concurrent hypertensive encephalopathy or aortic dissection, or other situations)
6. Other serious or life-threatening disease before the stroke:
6.1. Patient severely mentally or physically disabled (e.g. Mini Mental Status score less than 20, or modified Rankin Scale score more than or equal to four)
6.2. Life expectancy less than 12 months
7. Patient unavailable for follow-up (e.g. no fixed address)
8. Pregnant or breast-feeding woman

Recruitment start date

01/06/2005

Recruitment end date

01/06/2008

Locations

Countries of recruitment

Belgium, Denmark, Norway, Sweden

Trial participating centre

Department of Internal Medicine
Oslo
NO-0407
Norway

Sponsor information

Organisation

Ullevaal University Hospital (Norway)

Sponsor details

Attn. Director of Research Andreas Moan
Research Forum
Ullevaal University Hosptial
Kirkeveien 166
Oslo
NO-0407
Norway
+47 23 01 68 82
andreas.moan@uus.no

Sponsor type

Hospital/treatment centre

Website

http://www.ulleval.no

Funders

Funder type

Government

Funder name

Eastern Norway Regional Health Authority (Norway)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ullevaal University Hospital (Norway)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

AstraZeneca Ltd

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

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21316752

Publication citations

  1. Results

    Sandset EC, Bath PM, Boysen G, Jatuzis D, Kõrv J, Lüders S, Murray GD, Richter PS, Roine RO, Terént A, Thijs V, Berge E, , The angiotensin-receptor blocker candesartan for treatment of acute stroke (SCAST): a randomised, placebo-controlled, double-blind trial., Lancet, 2011, 377, 9767, 741-750, doi: 10.1016/S0140-6736(11)60104-9.

Additional files

Editorial Notes