Scandinavian Candesartan Acute Stroke Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Death or major disability (defined by the modified Rankin scale) at 6 months
研究概览
简要总结
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 blood pressure.
Hypothesis:
AT1 receptor blockade with candesartan in acute stroke will:
- reduce the risk of death or major disability at 6 months by a 6% absolute risk reduction, relative to placebo.
- reduce the risk of the combined event of "vascular" death, myocardial infarction, or stroke during the first 6 months by a 25% relative risk reduction, relative to placebo
详细描述
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 of stroke, to avoid reduction of cerebral blood perfusion. This practice has a well-founded theoretical basis, but is not supported by evidence from clinical trials. The newly published study ACCESS (Stroke 2003;34:1699) showed a clear beneficial effect of the angiotensin receptor blocker candesartan in the acute phase of stroke, but the trial was seriously underpowered.
The Scandinavian Candesartan Acute Stroke Trial (SCAST) is designed to provide reliable data on the effects of candesartan in a wide variety of patients with acute stroke (target recruitment 2,500). Patients presenting with acute stroke (<30 hours) and systolic blood pressure ≥140 mm Hg will be randomly assigned to candesartan 4 to 16 mg once daily or matching placebo for 7 days, followed by candesartan treatment for 6 months for patients who are hypertensive at the end of the treatment period (at clinician's discretion). Follow-up will be performed double-blind at 30 days, 3 months and 6 months.
The trial is co-ordinated from Ullevaal University Hospital in Oslo, Norway. Over 100 centres from Norway, Sweden, Denmark and Belgium have agreed to participate. Financial contributors: The Eastern Norway Regional Health Authority, AstraZeneca, and Ullevaal University Hospital (Oslo). AstraZeneca will supply drugs and placebo for the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Candesartan Cilexetil
Candesartan Cilexetil
干预措施: Candesartan Cilexetil (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Death or major disability (defined by the modified Rankin scale) at 6 months
时间窗: 6 months
The composite event "vascular" death, myocardial infarction, or stroke during the first 6 months
时间窗: 6 months
次要结局
- EuroQol score at 6 months(6 months)
- Myocardial infarction(6 months)
- Renal failure(7 days)
- Mini-Mental State score at 6 months(6 months)
- Death (all-cause death and "vascular" death)(6 months)
- Recurrent stroke (ischaemic, haemorrhagic, or unspecified)(6 months)
- Scandinavian Stroke Scale score at 7 days(7 days)
- Barthel Index score at 6 months(6 months)
- Combination of the above events(6 months)
- Symptomatic hypotension(7 days)