Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000362392
Ethics application status
Approved
Date submitted
9/07/2008
Date registered
25/07/2008
Date last updated
22/08/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The second intensive Blood Pressure reduction in acute cerebral haemorrhage trial.
Scientific title
An international randomised controlled trial to establish the effects of early intensive blood pressure lowering in patients with intracerebral haemorrhage
Secondary ID [1] 281146 0
NCT00716079
Universal Trial Number (UTN)
Trial acronym
INTERACT 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
intracerebral haemorrhage 3179 0
Condition category
Condition code
Stroke 3339 3339 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomised to either intensive blood pressure lowering or current guideline based management. As the trial is an assessment of Blood pressure (BP) management policies, there is some flexibility in the use of particular BP lowering agents to achieve BP targets. Intravenous treatment protocols, based on available medications, are provided. Only licensed drugs are used such as labetolol hydrochloride, metoprolol tartrate, hydralazine hydrochloride, glyceral trinitrate and phentoloamine. Intensive therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour and to maintain this pressure during hospitalisation and for 3 months post hospitalisation. Oral or nasogastric treatment should be commenced within 24 hours. Control group therapy will include less intensive management of BP using similar choice of route and agents if systolic blood pressure rises above 180mmHg. The target of control therapy is to manage blood pressure according to guidelines, which state blood pressure should be <180mmHg. Follow up is 3 months for both groups.
Intervention code [1] 2911 0
Treatment: Drugs
Comparator / control treatment
Usual care - standard Blood Pressure lowering based on the American Heart Association (AHA)
Control group
Active

Outcomes
Primary outcome [1] 4227 0
A composite of death or dependency, with dependency being defined by a score of 3 to 5 on the modified Rankin Score (mRS).
Timepoint [1] 4227 0
90 days
Secondary outcome [1] 7142 0
A composite of death or dependency in a subgroup of patients who receive treatment within 4 hours of Intracerebral Haemorrhage (ICH) onset.
Timepoint [1] 7142 0
28 days and 90 days
Secondary outcome [2] 7563 0
Mortality
Timepoint [2] 7563 0
28 days and 90 days
Secondary outcome [3] 7564 0
Dependency (measured by modified Rankin Score (mRS)).
Timepoint [3] 7564 0
28 days and 90 days
Secondary outcome [4] 7565 0
Health related quality of life (measured by the EuroQuol 5D)
Timepoint [4] 7565 0
28 days and 90 days
Secondary outcome [5] 7566 0
Recurrent stroke defined as an acute disturbance of focal neurological function with symptoms lasting more than 24 hours due to new onset ICH or cerebral ischaemia, confirmed by neuro-imaging (or necropsy), that has occurred after an unequivocal period of neurological stability after 24 hours of the initial ICH
Timepoint [5] 7566 0
90 days
Secondary outcome [6] 7567 0
Acute myocardial infarction (or sudden death) from a cardiovascular cause
Timepoint [6] 7567 0
28 days and 90 days
Secondary outcome [7] 7568 0
Need for permanent residential care (eg hostel or nursing home)
Timepoint [7] 7568 0
90 days
Secondary outcome [8] 7569 0
Duration of initial hospital stay
Timepoint [8] 7569 0
End of hospital stay

Eligibility
Key inclusion criteria
Patients with computerised tomography (CT)-confirmed spontaneous Intracerebral Haemorrhage (ICH) and elevated systolic blood pressure (>150mmHg and <220mmHg), capacity to commence randomly assigned treatment within 6 hours of onset of ICH.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clear indication or contraindication to intensive BP lowering. Evidence ICH secondary to a structural abnormality, or use of thrombolytic agent, an ischaemic stroke within 30 days, a score of 3-5 on the Glasgow Coma Scale (indicating deep coma), significant pre-stroke disability or medical illness, planned early neurological intervention and participation in another clinical trial.

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)
Randomisation is performed through the centralised web-based system and the treatment group is concealed until assigned.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Assignment to a treatment group is determined by a computerised algorithm which runs on the central database and uses the minimisation method. The stratification factors are country, site and time since onset.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2008
Actual
13/10/2008
Date of last participant enrolment
Anticipated
Actual
30/08/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
2800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 988 0
2050
Recruitment outside Australia
Country [1] 980 0
China
State/province [1] 980 0
Country [2] 981 0
France
State/province [2] 981 0
Country [3] 982 0
New Zealand
State/province [3] 982 0
Country [4] 983 0
Germany
State/province [4] 983 0
Country [5] 984 0
Spain
State/province [5] 984 0
Country [6] 985 0
United Kingdom
State/province [6] 985 0
Country [7] 986 0
Belgium
State/province [7] 986 0
Country [8] 987 0
Netherlands
State/province [8] 987 0
Country [9] 988 0
Switzerland
State/province [9] 988 0
Country [10] 989 0
Austria
State/province [10] 989 0
Country [11] 990 0
Austria
State/province [11] 990 0

Funding & Sponsors
Funding source category [1] 3414 0
Government body
Name [1] 3414 0
National Health and Medical Research Council (NHMRC)
Country [1] 3414 0
Australia
Primary sponsor type
Other
Name
The George Institute for International Health
Address
PO Box M201 Missenden Road,
Camperdown
NSW 2050
Country
Australia
Secondary sponsor category [1] 3058 0
None
Name [1] 3058 0
Address [1] 3058 0
Country [1] 3058 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5610 0
SSWAHS RPAH zone
Ethics committee address [1] 5610 0
Ethics committee country [1] 5610 0
Date submitted for ethics approval [1] 5610 0
11/06/2008
Approval date [1] 5610 0
26/06/2008
Ethics approval number [1] 5610 0
08/RPAH/273

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28608 0
Prof Craig Anderson
Address 28608 0
The George Institute for Global Health, Level 10 King George V Building Missenden Road Camperdown NSW 2050
Country 28608 0
Australia
Phone 28608 0
+61 2 99934500
Fax 28608 0
Email 28608 0
[email protected]
Contact person for public queries
Name 11765 0
Emma Heeley
Address 11765 0
The George Institute Royal Prince ALfred Hospital Level 10 King George V Building Missenden Road Camperdown NSW 2050
Country 11765 0
Australia
Phone 11765 0
+61 2 99934561
Fax 11765 0
+61 2 99934502
Email 11765 0
[email protected]
Contact person for scientific queries
Name 2693 0
Craig Anderson
Address 2693 0
The George Institute Royal Prince ALfred Hospital Level 10 King George V Building Missenden Road Camperdown NSW 2050
Country 2693 0
Australia
Phone 2693 0
+61 2 99934590
Fax 2693 0
+61 2 99934502
Email 2693 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.