The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial
Information source: The George Institute
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Intracerebral Hemorrhage; Stroke; Hypertension; Clinical Trial
Intervention: Blood pressure management policies (Other)
Phase: N/A
Status: Recruiting
Sponsored by: The George Institute Official(s) and/or principal investigator(s):
Craig Anderson, PhD, Principal Investigator, Affiliation: The George Institute
Overall contact:
Emma Heeley, PhD, Phone: +61299934561, Email: eheeley@george.org.au
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.
Clinical Details
Official title: An International Randomised Controlled Trial to Establish the Effects of Early Intensive Blood Pressure Lowering in Patients With Intracerebral Haemorrhage.
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: A composite of death or dependency, with dependency being defined by a score of 3 to 5 on the modified Rankin Scale (mRS)
Secondary outcome: death and dependency in patients treated <4 hours; death; dependency; HRQoL; physical function; recurrent vascular events; days of hospitalisation; permanent residential care
Detailed description:
Intracerebral haemorrhage (ICH) is one of the most serious subtypes of stroke, affecting
over a million people worldwide each year, most of whom live in Asia. About one third of
people with ICH die early after onset and the majority of survivors are left with major
long-term disability. Despite the magnitude of the disease burden and cost on healthcare
resources, there remains uncertainty about the role of surgery for ICH and no acute medical
therapies have been shown to definitely alter outcome in ICH.
The INTERACT2 study follows the recently completed initial pilot study vanguard phase) which
established the feasibility of the protocol, safety of early intensive BP lowering, and
effects on haematoma expansion within 6 hours of onset of ICH. Having established
'proof-of-concept' that BP lowering may improve outcome by reducing haematoma expansion,
INTERACT2 aims to establish the effects of the treatment on major clinical endpoints in
patients with ICH recruited from an expanding clinical network around the world.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
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.
Locations and Contacts
Emma Heeley, PhD, Phone: +61299934561, Email: eheeley@george.org.au
Medizinische Universitat Innsbruck, Innsbruck A-6020, Austria; Not yet recruiting
Erich Schmutzhard, Phone: +43 512 23853, Email: erich.schmutzhard@i-med.ac.at
Erich Schmutzhard, Principal Investigator
Landesklinikum Donauregion Tulln, Tulln 3430, Austria; Not yet recruiting
Michael Brainin, Phone: 43 (0) 2272 601 10721, Email: michael.brainin@donau-uni.ac.at
Michael Brainin, Principal Investigator
Allgemeines Krankenhaus Linz, Linz 4020, Austria; Not yet recruiting
Franz Gruber, Phone: + 43 732 7806 6815, Email: franz.gruber@akh.linz.at
Franz Gruber, Principal Investigator
Krankenhaus Barmherzige Bruder, Vienna A-1020, Austria; Not yet recruiting
Wilfried Lang, Phone: + 43 (0) 1-21121-3241, Email: wilfried.lang@bbwien.at
Wilfried Lang, Principal Investigator
Regional Coordinating and Monitoring Centre: Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai Institute of Hypertension, Shanghai Second Medical University, Shanghai 200025, China; Recruiting
Jiguang Wang, Professor, Phone: +86 21 64662193
Jiguang Wang, Professor, Principal Investigator
Regional Coordinating Centre China: The George Institute China, Beijing 100088, China; Recruiting
Jian Sun, Phone: +86 1082800577, Ext: 205, Email: sjian@george.org
Yinging Huang, PhD, Principal Investigator
Regional Coordinating Centre Europe: Hospital Lariboisiere, Paris 75475, France; Not yet recruiting
Serge Merchand, Phone: +33 1 4995 6946
Christian Stapf, Principal Investigator
Regional Coordinating Centre India: The George Institute India, Hyderabad, Andhra Pradesh 500 033, India; Not yet recruiting
Hemalata Boyini, Phone: +914023558091, Ext: 205, Email: h.boyini@george.org.in
Subash Kaul, Principal Investigator
Concord Hospital, Concord, New South Wales 2138, Australia; Recruiting
Rosie Portley, Email: rosie.portley@email.cs.nsw.gov.au
Alastair Corbett, Principal Investigator
Gosford Hospital, Gosford, New South Wales 2250, Australia; Recruiting
Margaret Webb, Email: mmwebb@nsccahs.health.nsw.gov.au
Jonathan Sturm, Principal Investigator
John Hunter Hospital, Newcastle, New South Wales 2310, Australia; Recruiting
Andrea Moore, Phone: +61 2 4921 1211, Email: Andrea.Moore@mater.health.nsw.gov.au
Christopher Levi, Principal Investigator
Royal Prince Alfred Hospital, Sydney, New South Wales 2050, Australia; Recruiting
Nadia Schweizer, RN, Phone: +61-2-9515-5513, Email: nadia.schweizer@email.cs.nsw.gov.au
Craig Anderson, Principal Investigator
Alfred Hospital, Melbourne, Victoria 3181, Australia; Recruiting
Richard Gerraty, PhD FRACP, Principal Investigator
Austin Health, Melbourne, Victoria, Australia; Recruiting
Dennis Young, Phone: +61 0394962648, Email: dyoung@nsri.org.au
Helen Dewey, Principal Investigator
Box Hill Hospital, Melbourne, Victoria 3128, Australia; Recruiting
Kelly Coughlan, Phone: +61-3-8892-3609, Email: kelly.coughlan@easternhealth.org.au
Christopher Bladin, Principal Investigator
Royal Melbourne Hospital, Melbourne, Victoria 3050, Australia; Recruiting
Gillian McCarthy, Phone: +61-3-9342-7743, Email: gillian.mccarthy@mh.org.au
Stephen Davis, Principal Investigator
Sir Charles Gairdner Hospital, Perth, Western Australia 6009, Australia; Recruiting
David Blacker, MBBS, Email: David.Blacker@health.wa.gov.au
Ellen Baker, Email: ellen.baker@health.wa.gov.au
David Blacker, Principal Investigator
Additional Information
Further information on INTERACT2 is available on the George Institute for International health's website.
Related 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. Epub 2008 Apr 7.
Starting date: September 2008
Ending date: December 2011
Last updated: March 19, 2009
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