ENhanced Control of Hypertension ANd Thrombolysis strokE stuDy: a multicentre randomised trial

The George Institute for Global Health (Australia)0 个研究点目标入组 4,587 人开始时间: 2011年11月4日最近更新: 2019年6月26日

试验速览

•1. General criteria for use of thrombolytic treatment with rtPA:
•1.1. Adult (age =18 years)
•1.2. A clinical diagnosis of acute ischaemic stroke confirmed by brain imaging
•1.3. Able to receive treatment within 4.5 hours after the definite time of onset of symptoms
•1.4. Have a systolic BP =185 mmHg (i.e. the guideline recommended level of eligibility for rtPA; patients with higher BP levels at presentation can still be included provided the BP is reduced to the entry level prior to commencement of the randomised treatment).
•1.5. Provide informed consent (or via an appropriate proxy, according to local requirements)
•2. Specific criteria for arm [A] of low-dose vs standard-dose rtPA.
•2.1. No definite indication nor contraindication for either low-dose or standard-dose rtPA.
•3. Specific criteria for arm [B] of intensive BP lowering vs guideline recommended BP control
•3.1. Sustained elevated systolic BP level, defined as 2 readings =150 and =185 mmHg (i.e. the upper level for contraindication to use of thrombolysis)
•3.2. No definite indication or contraindication to either immediate intensive? BP lowering (to a target of 140-150 mmHg systolic) versus guideline-based BP control (e.g. intensive BP lowering is feasible and does not appear to pose excessive hazard to the patient).

•Patients will not be eligible if there is one or more of the following:
•1. Unlikely to potentially benefit from the therapy (e.g. advanced dementia, known severe pre-stroke disability (mRS scores 3-5), or a very high likelihood of death within 24 hours of stroke onset
•2. Other medical illness that interferes with outcome assessments and follow-uP

发起方

The George Institute for Global Health (Australia)