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| [ ...Back to search results ] | [ Print-friendly version ] |
| Scandinavian Candesartan Acute Stroke Trial |
| ISRCTN | ISRCTN13643354 |
| ClinicalTrials.gov identifier | NCT00120003 |
| Public title | Scandinavian Candesartan Acute Stroke Trial |
| Scientific title | |
| Acronym | SCAST |
| Serial number at source | Version/Date 050708 |
| 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 |
| Lay summary | |
| 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 |
| Countries of recruitment | Belgium, Denmark, Norway, Sweden |
| Disease/condition/study domain | Acute stroke |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/06/2005 |
| Anticipated end date | 01/06/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 2,500 |
| Interventions | Candesartan or matching placebo for seven days (4 - 16 mg) |
| 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 |
| 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 |
| Sources of funding |
1. Eastern Norway Regional Health Authority (Norway)
2. Ullevaal University Hospital (Norway) 3. AstraZeneca Ltd |
| Trial website | http://www.scast.no |
| Publications | 1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21316752 |
| Contact name | Dr Eivind Berge |
| Address |
Department of Internal Medicine
Ullevaal University Hospital Kirkeveien 166 |
| City/town | Oslo |
| Zip/Postcode | NO-0407 |
| Country | Norway |
| Tel | +47 22 11 91 01 |
| Fax | +47 22 11 82 80 |
| eivind.berge@medisin.uio.no | |
| Sponsor | Ullevaal University Hospital (Norway) |
| Address |
Attn. Director of Research Andreas Moan
Research Forum Ullevaal University Hosptial Kirkeveien 166 |
| City/town | Oslo |
| Zip/Postcode | NO-0407 |
| Country | Norway |
| Tel | +47 23 01 68 82 |
| Fax | +47 23 01 84 79 |
| andreas.moan@uus.no | |
| Sponsor website: | http://www.ulleval.no |
| Date applied | 08/09/2006 |
| Last edited | 06/04/2011 |
| Date ISRCTN assigned | 10/11/2006 |
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| © 2012 ISRCTN unless otherwise stated. | |
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