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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
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
Secondary ID [1] 0 0
NDA1INTERACT
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
CVA (Cerebrovascular Accident) 0 0
Cerebral Hemorrhage 0 0
Intracranial Hemorrhages 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Combination death and dependency, according to a 3-6 scores on the modified Rankin Score.
Timepoint [1] 0 0
3 months
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
24 and 72 hours, 1 and 3 months

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2007
Sample size
Target
Accrual to date
Final
404
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Concord Hospital - Concord
Recruitment hospital [2] 0 0
Gosford Hospital - Gosford
Recruitment hospital [3] 0 0
St George Hospital - Kogarah
Recruitment hospital [4] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [5] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [6] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [7] 0 0
Westmead Hospital - Westmead
Recruitment hospital [8] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [9] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [10] 0 0
St Vincent's Hospital - Melbourne
Recruitment hospital [11] 0 0
Box Hill Hospital - Melbourne
Recruitment hospital [12] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [13] 0 0
Austin Health - Melbourne
Recruitment hospital [14] 0 0
Monash Medical Centre - Melbourne
Recruitment hospital [15] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment postcode(s) [1] 0 0
2138 - Concord
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2310 - Newcastle
Recruitment postcode(s) [5] 0 0
2010 - Sydney
Recruitment postcode(s) [6] 0 0
2050 - Sydney
Recruitment postcode(s) [7] 0 0
2145 - Westmead
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
3050 - Melbourne
Recruitment postcode(s) [10] 0 0
3065 - Melbourne
Recruitment postcode(s) [11] 0 0
3128 - Melbourne
Recruitment postcode(s) [12] 0 0
3181 - Melbourne
Recruitment postcode(s) [13] 0 0
- Melbourne
Recruitment postcode(s) [14] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing
Country [2] 0 0
China
State/province [2] 0 0
Shanghai
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland
Country [4] 0 0
New Zealand
State/province [4] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Other
Name
The George Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00226096
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Craig Anderson, PhD
Address 0 0
The George Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries