Last updated: October 5, 2021
Sponsor: The George Institute
Overall Status: Completed
Phase
3
Condition
Stroke
Diabetes And Hypertension
Stress
Treatment
N/AClinical Study ID
NCT01422616
X11-0123
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 ofsymptoms
- Have a systolic BP ≤185 mmHg
- Provide informed consent (or via an appropriate proxy, according to localrequirements) Specific criteria for arm [A] of low-dose vs standard-dose rtPA (Recruitment completed inAugust 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 dosewithin 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
Exclusion Criteria:
- Unlikely to potentially benefit from the therapy (e.g. advanced dementia), or a veryhigh likelihood of death within 24 hours of stroke onset.
- Other medical illness that interferes with outcome assessments and follow-up [knownsignificant pre-stroke disability (mRS scores 2-5)].
- Specific contraindications to rtPA (Actilyse) or any of the blood pressure agents tobe used.
- Participation in another clinical trial involving evaluation of pharmacologicalagents.
- Need for following concomitant medication, including phosphodiesterase inhibitors andmonoamine oxidase inhibitors.
Study Design
Total Participants: 4587
Study Start date:
March 01, 2012
Estimated Completion Date:
August 31, 2018
Study Description
Connect with a study center
Royal Prince Alfred Hospital
Sydney, New South Wales 2050
AustraliaSite Not Available
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