Status:
COMPLETED
Scandinavian Candesartan Acute Stroke Trial (SCAST)
Lead Sponsor:
Ullevaal University Hospital
Collaborating Sponsors:
Southern-Eastern Norway Health Authorities RHF
AstraZeneca
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this trial is to assess whether the blood pressure lowering agent candesartan (an angiotensin receptor type 1 blocker) is effective when given to patients with acute stroke and elevated...
Detailed Description
It has long been a controversy whether elevated blood pressure should be lowered in the acute phase of stroke. Current clinical practice is generally to accept high blood pressure in the acute phase o...
Eligibility Criteria
Inclusion
- Clinical stroke syndrome with limb paresis, not likely to represent a transient ischaemic attack or non-stroke pathology (e.g. cerebral tumour)
- Systolic blood pressure ≥ 140 mm Hg
- Trial treatment possible within 30 hrs of symptom onset. If time of onset is not known, use the time when the patient was last known to be well.
- Consent (subsidiary, assent from legal acceptable representative, or waiver of consent)
- Age \>18 years
Exclusion
- Markedly reduced consciousness (i.e. Scandinavian Stroke Scale consciousness score ≤ 2)
- Patient already receiving AT1 receptor blocker
- Contraindication to treatment with AT1 receptor blocker, e.g.:
- known renal failure (women: creatinine ≥ 150 µmol/L; men: ≥ 180 µmol/L)
- previously diagnosed bilateral renal artery stenosis
- previously diagnosed high-grade aortic stenosis
- previously diagnosed seriously impaired liver function and/or cholestasis
- known intolerance to candesartan or other tablet ingredients
- 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-IV, in the presence of intolerance to ACE inhibitors)
- Clear indication, in the clinician's view, for antihypertensive therapy during the acute phase of stroke (i.e. concurrent hypertensive encephalopathy or aortic dissection, or other situations)
- Other serious or life-threatening disease before the stroke:
- Patient severely mentally or physically disabled (e.g. Mini Mental Status score \< 20, or modified Rankin Scale score ≥ 4)
- Life expectancy \< 12 months
- Patient unavailable for follow-up (e.g. no fixed address)
- Pregnant or breast-feeding woman
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2010
Estimated Enrollment :
2500 Patients enrolled
Trial Details
Trial ID
NCT00120003
Start Date
June 1 2005
End Date
September 1 2010
Last Update
July 1 2011
Active Locations (1)
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1
Ullevaal University Hospital
Oslo, Norway, NO-0407