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-label, blinded endpoint (PROBE) controlled trial that involved 4587 patients (3310 for rtPA arm {recruitment completed in August 2015} and 2227 for BP arm {recruitment completed in April 2018} with 939 overlap) with acute ischaemic stroke recruited from over 100+ Clinical Centres from Australia, Asia, Europe and South America.
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.