跳至主要内容
临床试验/EUCTR2011-005545-12-GB
EUCTR2011-005545-12-GB进行中(未招募)1 期

Enhanced Control of Hypertension and Thrombolysis Stroke Trial - ENCHANTED

niversity of Leicester0 个研究点目标入组 5,000 人开始时间: 2012年1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
5,000

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

  • The overall inclusion criteria for thrombolysis are: aged >18 years, clinical AIS diagnosis confirmed by brain imaging, able to receive treatment within 3 hours after definite onset time (though this time window may change with the forthcoming NICE Single Technology Appraisal review and further trial publications), SBP <185mmHg (patients with higher SBP levels can be treated provided the SBP level is reduced prior to commencement of treatment), and informed patient consent (or relative assent). In addition, specific criteria for the two arms include: [A] no definite indication or contraindication for either low- or standard-dose rtPA; and [B] sustained elevated SBP level (defined as 2 readings >150 and <185mmHg), and no definite indication or contraindication to either immediate ‘intensive’- or guideline-based BP control.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 0
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 0

排除标准

  • Patients will be excluded if they are unlikely to benefit from therapy (e.g. advanced dementia, known severe pre-stroke disability (Modified Rankin score, mRS >3), or high likelihood of death within 24 hours), or other medical co-morbidities that interfere with outcome assessments or follow-up.

研究者

发起方
niversity of Leicester

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