Scandinavian Candesartan Acute Stroke Trial

ISRCTN	ISRCTN13643354
DOI	https://doi.org/10.1186/ISRCTN13643354
ClinicalTrials.gov (NCT)	NCT00120003
Protocol serial number	Version/Date 050708
Sponsor	Ullevaal University Hospital (Norway)
Funders	Eastern Norway Regional Health Authority (Norway), Ullevaal University Hospital (Norway), AstraZeneca Ltd

Submission date: 08/09/2006
Registration date: 10/11/2006
Last edited: 06/04/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Eivind Berge
Scientific

Department of Internal Medicine
Ullevaal University Hospital
Kirkeveien 166
Oslo
NO-0407
Norway

Phone	+47 22 11 91 01
Email	eivind.berge@medisin.uio.no

Study information

Primary study design	Interventional
Study design	Multicentre, randomised- and placebo-controlled, double blind study
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	SCAST
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	Acute stroke
Intervention	Candesartan or matching placebo for seven days (4 - 16 mg)
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Candesartan
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	01/06/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	2500
Key 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
Key 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 clinicians 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 clinicians 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
Date of first enrolment	01/06/2005
Date of final enrolment	01/06/2008

Locations

Countries of recruitment

Belgium
Denmark
Norway
Sweden

Study participating centre

Department of Internal Medicine

Oslo
NO-0407
Norway

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	26/02/2011		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes