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
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