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临床试验/EUCTR2004-002187-22-BE
EUCTR2004-002187-22-BE进行中(未招募)1 期

Scandinavian Candesartan Acute Stroke Trial - SCAST

llevål University Hospital0 个研究点目标入组 2,500 人开始时间: 2006年2月9日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
2,500

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 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 = 140 mm Hg (see paragraph 7.1 for details)
  • 3. 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.
  • 4. Consent (subsidiary, assent from legal acceptable representative, or waiver of consent, see paragraph 7.2 in protocol for details)
  • 5. Age >18 years
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1. Markedly reduced consciousness (e.g. Scandinavian Stroke Scale consciousness score = 2)
  • 2. Patient already receiving AT1 receptor blocker
  • 3. 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
  • 4. Clear indication, in the clinician’s view, for start of treatment with AT1 receptor blocker during the treatment period
  • 5. 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)
  • 6. Other serious or life-threatening disease before the stroke:
  • patient severely mentally or physically disabled (e.g. Mini Mental Status score < 15-20, or modified Rankin Scale score = 4)
  • life expectancy < 12 months
  • 7. Patient unavailable for follow-up (e.g. no fixed address)
  • 8. Pregnant or breast-feeding woman

研究者

发起方
llevål University Hospital

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