Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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] 0 0
NHMRC-571281
Universal Trial Number (UTN)
Trial acronym
INTERACT2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intracerebral Hemorrhage 0 0
Stroke 0 0
Hypertension 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS)
Timepoint [1] 0 0
90 days
Secondary outcome [1] 0 0
Death at 90 Days
Timepoint [1] 0 0
90 days

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
Minimum age
18 Years
Maximum age
No limit
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
* 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.

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
NA
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
1/09/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2012
Sample size
Target
Accrual to date
Final
2839
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Canberra
Recruitment hospital [2] 0 0
Concord Hospital - Concord
Recruitment hospital [3] 0 0
Gosford Hospital - Gosford
Recruitment hospital [4] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [5] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [6] 0 0
Royal Brisbane and Women's Hospital Health Service District - Brisbane
Recruitment hospital [7] 0 0
Western Hospital - Melbourne
Recruitment hospital [8] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [9] 0 0
Austin Repatriation General Hospital - Melbourne
Recruitment hospital [10] 0 0
Box Hill Hospital - Melbourne
Recruitment hospital [11] 0 0
Monash Medical Centre - Melbourne
Recruitment hospital [12] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment postcode(s) [1] 0 0
2605 - Canberra
Recruitment postcode(s) [2] 0 0
2138 - Concord
Recruitment postcode(s) [3] 0 0
2250 - Gosford
Recruitment postcode(s) [4] 0 0
2310 - Newcastle
Recruitment postcode(s) [5] 0 0
2050 - Sydney
Recruitment postcode(s) [6] 0 0
4029 - Brisbane
Recruitment postcode(s) [7] 0 0
3011 - Melbourne
Recruitment postcode(s) [8] 0 0
3050 - Melbourne
Recruitment postcode(s) [9] 0 0
3081 - Melbourne
Recruitment postcode(s) [10] 0 0
3128 - Melbourne
Recruitment postcode(s) [11] 0 0
3168 - Melbourne
Recruitment postcode(s) [12] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Minnesota
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Austria
State/province [3] 0 0
Graz
Country [4] 0 0
Austria
State/province [4] 0 0
Innsbruck
Country [5] 0 0
Austria
State/province [5] 0 0
Linz
Country [6] 0 0
Belgium
State/province [6] 0 0
Jette
Country [7] 0 0
Belgium
State/province [7] 0 0
La Louviere
Country [8] 0 0
Brazil
State/province [8] 0 0
Sao Paulo
Country [9] 0 0
Chile
State/province [9] 0 0
Santiago
Country [10] 0 0
China
State/province [10] 0 0
Beijing
Country [11] 0 0
China
State/province [11] 0 0
Shanghai
Country [12] 0 0
Finland
State/province [12] 0 0
Helsinki
Country [13] 0 0
France
State/province [13] 0 0
Besancon
Country [14] 0 0
France
State/province [14] 0 0
Brest
Country [15] 0 0
France
State/province [15] 0 0
Calais
Country [16] 0 0
France
State/province [16] 0 0
Kremlin-Bicetre
Country [17] 0 0
France
State/province [17] 0 0
Lille
Country [18] 0 0
France
State/province [18] 0 0
Meaux
Country [19] 0 0
France
State/province [19] 0 0
Nantes
Country [20] 0 0
France
State/province [20] 0 0
Paris
Country [21] 0 0
France
State/province [21] 0 0
Saint-Denis
Country [22] 0 0
France
State/province [22] 0 0
Versailles
Country [23] 0 0
Germany
State/province [23] 0 0
Berlin
Country [24] 0 0
Germany
State/province [24] 0 0
Dresden
Country [25] 0 0
Germany
State/province [25] 0 0
Dusseldorf
Country [26] 0 0
Germany
State/province [26] 0 0
Erlangen
Country [27] 0 0
Germany
State/province [27] 0 0
Frankfurt
Country [28] 0 0
Germany
State/province [28] 0 0
Halle
Country [29] 0 0
Germany
State/province [29] 0 0
Hamburg
Country [30] 0 0
Germany
State/province [30] 0 0
Heidelberg
Country [31] 0 0
Germany
State/province [31] 0 0
Mannheim
Country [32] 0 0
Germany
State/province [32] 0 0
Ulm
Country [33] 0 0
Hong Kong
State/province [33] 0 0
Sha Tin
Country [34] 0 0
India
State/province [34] 0 0
Andhra Pradesh
Country [35] 0 0
Italy
State/province [35] 0 0
Citta di Castello
Country [36] 0 0
Pakistan
State/province [36] 0 0
Karachi
Country [37] 0 0
Portugal
State/province [37] 0 0
Porto
Country [38] 0 0
Spain
State/province [38] 0 0
Albacete
Country [39] 0 0
Spain
State/province [39] 0 0
Barcelona
Country [40] 0 0
Spain
State/province [40] 0 0
Girona
Country [41] 0 0
Switzerland
State/province [41] 0 0
Bern
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Leicester

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
Trial website
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

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

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00716079