The National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, is looking for individuals to participate in clinical studies. Participating in clinical trials allows you to play an active role in research on the nature and causes of many disorders of the brain and nervous system, and to possibly help physician-scientists develop future treatments. The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible.

Description:

This study is an international, multicentre, prospective, fixed-time point (optional) randomisation for two arms ([A] 'dose of rtPA' and [B] 'level of BP control'), open, blinded endpoint (PROBE), controlled trial that will involve over 4700 patients (3310 for rtPA arm {recruitment completed in August 2015} and 2304 for BP arm with 939 overlap) with acute ischaemic stroke recruited from over 100+ Clinical Centres from Australia, Asia, Europe and South America.

Eligibility Criteria:

Inclusion Criteria: - Adult (age ≥18 years) - A clinical diagnosis of acute ischaemic stroke confirmed by brain imaging - Able to receive treatment within 4.5 hours after the definite time of onset of symptoms - Have a systolic BP ≤185 mmHg - Provide informed consent (or via an appropriate proxy, according to local requirements) Specific criteria for arm [A] of low-dose vs standard-dose rtPA (Recruitment completed in August 2015.): - Able to receive either low-dose or standard-dose rtPA Specific criteria for arm [B] of intensive BP lowering vs guideline recommended BP control - Patient will or has received thrombolysis treatment with rtPA, either randomised dose within the trial or physician decided dose rtPA outside of the trial - Sustained elevated systolic BP level, defined as 2 readings ≥ 150 mmHg - Able to commence intensive BP lowering treatment within 6 hours of stroke onset - Able to receive either immediate intensive BP lowering or conservative BP management Exclusion Criteria: - Unlikely to potentially benefit from the therapy (e.g. advanced dementia), or a very high likelihood of death within 24 hours of stroke onset. - Other medical illness that interferes with outcome assessments and follow-up [known significant pre-stroke disability (mRS scores 2-5)]. - Specific contraindications to rtPA (Actilyse) or any of the blood pressure agents to be used. - Participation in another clinical trial involving evaluation of pharmacological agents. - Need for following concomitant medication, including phosphodiesterase inhibitors and monoamine oxidase inhibitors.

Study Design:

Study Location:

United States