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