ISRCTN99414122已完成未知
A prospective, collaborative, international, multicentre, randomised, parallel-group, single and outcome blinded, controlled, factorial trial to investigate the safety and efficacy of treatment with transdermal glyceryl trinitrate, a nitric oxide donor, and of continuing or stopping temporarily pre-stroke antihypertensive therapy, in patients with acute stroke
niversity of Nottingham (UK)0 个研究点目标入组 3,500 人开始时间: 2002年11月12日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 3,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients with acute ischaemic or haemorrhagic stroke within 48 hours
- •2. Systolic blood pressure 140-220 mmHg
排除标准
- •1. Unconscious (Glasgow Coma Scale less than eight)
- •2. Definite need for nitrate therapy: concurrent myocardial infarction, unstable angina, left ventricular failure
- •3. Dehydration
- •4. Contraindication to nitrate therapy: hypersensitivity to nitrates, hypovolaemia, hypertrophic obstructive cardiomyopathy, aortic stenosis, cardiac tamponade, constrictive pericarditis, mitral stenosis, marked anaemia, closed-angle glaucoma, sildenafil (Viagra) within previous 24 hours
- •5. Systolic blood pressure less than 140 mmHg or more than 220 mmHg
- •6. Patients expected to require surgical intervention (e.g. clot evacuation, carotid endarterectomy) during the treatment or follow-up period
- •7. Refusal to consent
- •8. Patient dependent on others prior to stroke (e.g. Rankin score more than three)
- •9. Known intracerebral pathology other than ischaemic stroke, e.g. subarachnoid haemorrhage, brain tumour, cerebral abscess
- •10. Other serious condition which is likely to prevent outcome assessment, e.g. advanced cancer
- •11. Involvement in a trial of another experimental intervention (drug or surgery) for acute stroke
- •12. Not available for follow-up, e.g. no fixed address, overseas visitor
- •13. Females of childbearing potential, pregnancy or breastfeeding
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