EUCTR2004-000238-36-GB进行中（未招募）1 期
Third International Stroke Trial (IST-3) of thrombolysis for acute ischaemic stroke - IST-3
The University of Edinburgh & Lothian Health Board0 个研究点目标入组 3,100 人开始时间: 2007年8月23日最近更新:
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
- 3,100
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
入选标准
- •Symptoms and signs of clinically definite acute stroke.
- •Time of stroke onset is known and treatment can be started within six hours of this onset.
- •CT or MRI brain scanning has reliably excluded both intracranial haemorrhage and structural brain lesions which can mimic stroke (e.g cerebral tumour).
- •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
- •The patient has previously been randomised in IST-3
- •Major surgery, trauma (e.g. major fall at time of stroke) or gastrointestinal or urinary tract haemorrhage within the previous 21 days. Arterial puncture at a non-compressible site within the previous 7 days.
- •Any known defect in coagulation (e.g. currently on oral anticoagulants with an INR > 1.3 OR current treatment with heparin [unless APPT within normal laboratory limits] OR treatment with low molecular weight heparin or heparinoid OR treatment with ximelagatran).
- •Known defect of clotting or platelet function (but patients on antiplatelet agents can be randomised).
- •The patient is female and of childbearing potential (unless it is certain that pregnancy is not possible) or breast feeding.
- •Hypo- or hyperglycaemia sufficient to account for the neurological symptoms; the patient should be excluded if their blood glucose is < 3.0 or > 20.0 mmol/L ('stick testing' is a sufficiently accurate test for this purpose).
- •Symptoms considered likely to resolve completely within the next few hours (i.e. a TIA)
- •Patient has had a stroke within the previous 14 days or has had treatment for acute ischaemic stroke with thrombolytic therapy within the past 14 days.
- •Patient was already dependent in activities of daily living before the present acute stroke
- •Patient has other life threatening illness (e.g. advanced cancer) likely to lead to death within a few months.
- •Likely to be unavailable for follow-up e.g. no fixed home address.
- •Patient has Blood Pressure < 90 mm Hg or > 220 mm Hg or Diastolic Blood Pressure < 40 mm Hg or > 130 mm Hg
研究者
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