Scandinavian Candesartan Acute Stroke Trial
| ISRCTN | ISRCTN13643354 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13643354 |
| ClinicalTrials.gov number | NCT00120003 |
| Secondary identifying numbers | Version/Date 050708 |
- 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
Not provided at time of registration
Contact information
Dr Eivind Berge
Scientific
Scientific
Department of Internal Medicine
Ullevaal University Hospital
Kirkeveien 166
Oslo
NO-0407
Norway
| Phone | +47 22 11 91 01 |
|---|---|
| eivind.berge@medisin.uio.no |
Study information
| Study design | Multicentre, randomised- and placebo-controlled, double blind study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| Study 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(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) |
| Condition | Acute stroke |
| Intervention | Candesartan or matching placebo for seven days (4 - 16 mg) |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Candesartan |
| Primary outcome measure | 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 study start date | 01/06/2005 |
| Overall study end date | 01/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 2,500 |
| 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 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 |
| Recruitment start date | 01/06/2005 |
| Recruitment end date | 01/06/2008 |
Locations
Countries of recruitment
- Belgium
- Denmark
- Norway
- Sweden
Study participating centre
Department of Internal Medicine
Oslo
NO-0407
Norway
NO-0407
Norway
Sponsor information
Ullevaal University Hospital (Norway)
Hospital/treatment centre
Hospital/treatment centre
Attn. Director of Research Andreas Moan
Research Forum
Ullevaal University Hosptial
Kirkeveien 166
Oslo
NO-0407
Norway
| Phone | +47 23 01 68 82 |
|---|---|
| andreas.moan@uus.no | |
| Website | http://www.ulleval.no |
"ROR" |
https://ror.org/00j9c2840 |
Funders
Funder type
Government
Eastern Norway Regional Health Authority (Norway)
No information available
Ullevaal University Hospital (Norway)
No information available
AstraZeneca Ltd
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
