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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00226096
Registration number
NCT00226096
Ethics application status
Date submitted
23/09/2005
Date registered
26/09/2005
Date last updated
26/06/2008
Titles & IDs
Public title
Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage
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Scientific title
A Randomised Trial to Establish the Effects of Early Intensive Blood Pressure Lowering on Death and Disability in Patients With Stroke Due to Acute Intracerebral Haemorrhage
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Secondary ID [1]
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NDA1INTERACT
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
CVA (Cerebrovascular Accident)
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Cerebral Hemorrhage
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Intracranial Hemorrhages
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Condition category
Condition code
Stroke
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Haemorrhagic
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Stroke
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Ischaemic
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Neurological
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Other neurological disorders
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Cardiovascular
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Labetalol Hydrochloride
Treatment: Drugs - Metoprolol tartrate
Treatment: Drugs - Hydralazine Hydrochloride
Treatment: Drugs - Glycerol Trinitrate
Treatment: Drugs - Phentolamine mesylate
Treatment: Drugs - Nicardipine
Treatment: Drugs - Urapidil
Treatment: Drugs - Esmolol
Treatment: Drugs - Clonidine
Treatment: Drugs - Enalaprilat
Treatment: Drugs - Nitroprusside
Treatment: Drugs: Labetalol Hydrochloride
Treatment: Drugs: Metoprolol tartrate
Treatment: Drugs: Hydralazine Hydrochloride
Treatment: Drugs: Glycerol Trinitrate
Treatment: Drugs: Phentolamine mesylate
Treatment: Drugs: Nicardipine
Treatment: Drugs: Urapidil
Treatment: Drugs: Esmolol
Treatment: Drugs: Clonidine
Treatment: Drugs: Enalaprilat
Treatment: Drugs: Nitroprusside
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Combination death and dependency, according to a 3-6 scores on the modified Rankin Score.
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Assessment method [1]
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Timepoint [1]
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3 months
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Secondary outcome [1]
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All cause and cause-specific early neurological deterioration during the first 72 hours; haematoma expansion & cerebral oedema at 24 & 72 hours; ; functional disability; cognitive function; quality of life; mortality at 1 and 3 months
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Assessment method [1]
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Timepoint [1]
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24 and 72 hours, 1 and 3 months
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Eligibility
Key inclusion criteria
- Aged 18 years or above
- Acute stroke due to spontaneous ICH confirmed by clinical history & CT scan
- At least 2 systolic BP measurements of >/=150mmHg and </=220mmHg, recorded 2 or more
minutes apart
- Able to commence randomly assigned BP lowering regimen within 6 hours of stroke onset
- Able to be actively treated and admitted to a monitored facility e.g. HDU/ICU/acute
stroke unit
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Known definite contraindication to an intensive BP lowering regimen
- Known definite indication for intensive BP lowering regimen as (or more) intensive
than the active treatment arm
- Definite evidence that the ICH is secondary to a structural abnormality in the brain
- Previous ischaemic stroke within 30 days
- A very high likelihood that the patient will die within the next 24 hours on the basis
of clinical and/or radiological criteria
- Known advanced dementia or significant pre-stroke disability
- Concomitant medical illness that would interfere with outcome assessments and follow
up
- Already booked for surgical evacuation of haematoma
- Previous participation in this trial or current participation in another
investigational drug trial
- A high likelihood that the patient will not adhere to the study treatment and follow
up regimen
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2007
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Sample size
Target
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Accrual to date
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Final
404
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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Concord Hospital - Concord
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Recruitment hospital [2]
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Gosford Hospital - Gosford
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Recruitment hospital [3]
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St George Hospital - Kogarah
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Recruitment hospital [4]
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John Hunter Hospital - Newcastle
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Recruitment hospital [5]
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St Vincent's Hospital - Sydney
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Recruitment hospital [6]
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Royal Prince Alfred Hospital - Sydney
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Recruitment hospital [7]
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Westmead Hospital - Westmead
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Recruitment hospital [8]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [9]
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Royal Melbourne Hospital - Melbourne
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Recruitment hospital [10]
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St Vincent's Hospital - Melbourne
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Recruitment hospital [11]
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Box Hill Hospital - Melbourne
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Recruitment hospital [12]
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Alfred Hospital - Melbourne
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Recruitment hospital [13]
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Austin Health - Melbourne
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Recruitment hospital [14]
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Monash Medical Centre - Melbourne
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Recruitment hospital [15]
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Sir Charles Gairdner Hospital - Perth
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Recruitment postcode(s) [1]
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2138 - Concord
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Recruitment postcode(s) [2]
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2250 - Gosford
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Recruitment postcode(s) [3]
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2217 - Kogarah
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Recruitment postcode(s) [4]
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2310 - Newcastle
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Recruitment postcode(s) [5]
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2010 - Sydney
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Recruitment postcode(s) [6]
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2050 - Sydney
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Recruitment postcode(s) [7]
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2145 - Westmead
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Recruitment postcode(s) [8]
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5000 - Adelaide
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Recruitment postcode(s) [9]
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3050 - Melbourne
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Recruitment postcode(s) [10]
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3065 - Melbourne
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Recruitment postcode(s) [11]
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3128 - Melbourne
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Recruitment postcode(s) [12]
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3181 - Melbourne
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Recruitment postcode(s) [13]
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- Melbourne
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Recruitment postcode(s) [14]
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6009 - Perth
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Recruitment outside Australia
Country [1]
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China
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State/province [1]
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Beijing
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Country [2]
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China
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State/province [2]
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Shanghai
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Country [3]
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New Zealand
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State/province [3]
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Auckland
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Country [4]
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New Zealand
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State/province [4]
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Christchurch
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Funding & Sponsors
Primary sponsor type
Other
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Name
The George Institute
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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National Health and Medical Research Council, Australia
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of the study is to determine whether lowering high blood pressure levels after
the start of a stroke caused by bleeding in the brain (intracerebral haemorrhage) will reduce
the chances of a person dying or surviving with a long term disability. The study will be
undertaken in two phases: a vanguard phase in 400 patients, to plan for a main phase in 2000
patients.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00226096
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Craig Anderson, PhD
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Address
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The George Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00226096
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