Scandinavian Candesartan Acute Stroke Trial

Completed

• Conditions: Acute stroke; Circulatory System; Cardiovascular disease

• Registration Number: ISRCTN13643354
• Lead Sponsor: llevaal University Hospital (Norway)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-10
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2500

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified