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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/NCT00716079
Registration number
NCT00716079
Ethics application status
Date submitted
14/07/2008
Date registered
16/07/2008
Date last updated
13/12/2013
Titles & IDs
Public title
The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial
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Scientific title
An International Randomised Controlled Trial to Establish the Effects of Early Intensive Blood Pressure Lowering in Patients With Intracerebral Haemorrhage.
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Secondary ID [1]
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NHMRC-571281
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Universal Trial Number (UTN)
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Trial acronym
INTERACT2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Intracerebral Hemorrhage
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Stroke
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Hypertension
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Condition category
Condition code
Stroke
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Haemorrhagic
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Blood pressure management policies
Other: Intensive BP lowering - Management policy to lower the systolic Blood pressure (BP) to a target of 140mmHg within 1 hour of randomization and sustained for 24 hours. Sites were provided with protocols for different intravenous agents and used whichever routinely available drugs were in their hospital.
Other: Guideline recommended BP lowering - Patients received management of BP based on the standard guidelines at the time, as published by the American Heart Association (AHA) in 2007 and 2010. The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved.
Other interventions: Blood pressure management policies
The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets.
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Intervention code [1]
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Other interventions
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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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A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS)
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Assessment method [1]
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Timepoint [1]
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90 days
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Secondary outcome [1]
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Death at 90 Days
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Assessment method [1]
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Timepoint [1]
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90 days
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Eligibility
Key inclusion criteria
- Patients with CT-confirmed spontaneous Intracerebral Haemorrhage (ICH)
- Elevated systolic blood pressure (>150mmHg and <220mmHg)
- Capacity to commence randomly assigned treatment within 6 hours of onset of ICH.
- Able to be 'actively' treated and admitted to a monitored facility
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Minimum age
18
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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
- Clear indication or contraindication to intensive BP lowering.
- Evidence ICH secondary to a structural abnormality
- Use of thrombolytic agent
- 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
- Score of 3-5 on the Glasgow Coma Scale (indicating deep coma)
- Significant pre-stroke disability or advanced dementia
- Planned early neurological intervention
- Participation in another clinical 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
1/09/2008
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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
1/12/2012
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Sample size
Target
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Accrual to date
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Final
2839
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Canberra Hospital - Canberra
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Concord Hospital - Concord
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Gosford Hospital - Gosford
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John Hunter Hospital - Newcastle
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Royal Prince Alfred Hospital - Sydney
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Royal Brisbane and Women's Hospital Health Service District - Brisbane
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Western Hospital - Melbourne
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Royal Melbourne Hospital - Melbourne
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Austin Repatriation General Hospital - Melbourne
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Box Hill Hospital - Melbourne
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Monash Medical Centre - Melbourne
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Sir Charles Gairdner Hospital - Perth
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2605 - Canberra
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2138 - Concord
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2250 - Gosford
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2310 - Newcastle
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Recruitment postcode(s) [5]
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2050 - Sydney
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Recruitment postcode(s) [6]
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4029 - Brisbane
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Recruitment postcode(s) [7]
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3011 - Melbourne
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Recruitment postcode(s) [8]
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3050 - Melbourne
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Recruitment postcode(s) [9]
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3081 - Melbourne
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Recruitment postcode(s) [10]
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3128 - Melbourne
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Recruitment postcode(s) [11]
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3168 - Melbourne
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Recruitment postcode(s) [12]
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6009 - Perth
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Recruitment outside Australia
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United States of America
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Minnesota
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Argentina
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Buenos Aires
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Austria
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Graz
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Austria
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Innsbruck
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Austria
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Linz
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Jette
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La Louviere
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Chile
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Santiago
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China
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Beijing
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China
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Shanghai
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Finland
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Calais
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Meaux
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Nantes
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Paris
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Erlangen
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Germany
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Halle
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Heidelberg
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Mannheim
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Germany
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Ulm
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Sha Tin
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India
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Andhra Pradesh
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Italy
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Citta di Castello
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Pakistan
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Karachi
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Portugal
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Porto
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Girona
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Bern
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United Kingdom
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Leicester
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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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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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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this academic lead study is to determine if a treatment strategy of early
intensive blood pressure (BP) lowering compared to conservative BP lowering policy in
patients with elevated blood pressure within 6 hours of acute intracerebral haemorrhage (ICH)
improves the outcome of death and disability at 3 months after onset.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00716079
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Trial related presentations / publications
Anderson CS, Huang Y, Wang JG, Arima H, Neal B, Peng B, Heeley E, Skulina C, Parsons MW, Kim JS, Tao QL, Li YC, Jiang JD, Tai LW, Zhang JL, Xu E, Cheng Y, Heritier S, Morgenstern LB, Chalmers J; INTERACT Investigators. Intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT): a randomised pilot trial. Lancet Neurol. 2008 May;7(5):391-9. doi: 10.1016/S1474-4422(08)70069-3. Epub 2008 Apr 7.
Delcourt C, Huang Y, Wang J, Heeley E, Lindley R, Stapf C, Tzourio C, Arima H, Parsons M, Sun J, Neal B, Chalmers J, Anderson C; INTERACT2 Investigators. The second (main) phase of an open, randomised, multicentre study to investigate the effectiveness of an intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT2). Int J Stroke. 2010 Apr;5(2):110-6. doi: 10.1111/j.1747-4949.2010.00415.x.
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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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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00716079
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