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Sponsored by: |
The George Institute |
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Information provided by: | The George Institute |
ClinicalTrials.gov Identifier: | NCT00716079 |
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.
Condition | Intervention |
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Intracerebral Hemorrhage Stroke Hypertension Clinical Trial |
Other: Blood pressure management policies |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An International Randomised Controlled Trial to Establish the Effects of Early Intensive Blood Pressure Lowering in Patients With Intracerebral Haemorrhage. |
Estimated Enrollment: | 2800 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Intensive
Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour.
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Other: 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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Conservative
Patients will receive management of BP that is based on a standard guideline, as published by the American Heart Association (AHA). 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.
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Other: 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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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Emma Heeley, PhD | +61299934561 | eheeley@george.org.au |
Australia, New South Wales | |
Concord Hospital | Recruiting |
Concord, New South Wales, Australia, 2138 | |
Contact: Rosie Portley rosie.portley@email.cs.nsw.gov.au | |
Principal Investigator: Alastair Corbett | |
Gosford Hospital | Recruiting |
Gosford, New South Wales, Australia, 2250 | |
Contact: Margaret Webb mmwebb@nsccahs.health.nsw.gov.au | |
Principal Investigator: Jonathan Sturm | |
John Hunter Hospital | Recruiting |
Newcastle, New South Wales, Australia, 2310 | |
Contact: Andrea Moore +61 2 4921 1211 Andrea.Moore@mater.health.nsw.gov.au | |
Principal Investigator: Christopher Levi | |
Royal Prince Alfred Hospital | Recruiting |
Sydney, New South Wales, Australia, 2050 | |
Contact: Nadia Schweizer, RN +61-2-9515-5513 nadia.schweizer@email.cs.nsw.gov.au | |
Principal Investigator: Craig Anderson | |
Australia, Victoria | |
Royal Melbourne Hospital | Recruiting |
Melbourne, Victoria, Australia, 3050 | |
Contact: Gillian McCarthy +61-3-9342-7743 gillian.mccarthy@mh.org.au | |
Principal Investigator: Stephen Davis | |
Austin Health | Recruiting |
Melbourne, Victoria, Australia | |
Contact: Dennis Young +61 0394962648 dyoung@nsri.org.au | |
Principal Investigator: Helen Dewey | |
Box Hill Hospital | Recruiting |
Melbourne, Victoria, Australia, 3128 | |
Contact: Kelly Coughlan +61-3-8892-3609 kelly.coughlan@easternhealth.org.au | |
Principal Investigator: Christopher Bladin | |
Alfred Hospital | Recruiting |
Melbourne, Victoria, Australia, 3181 | |
Principal Investigator: Richard Gerraty, PhD FRACP | |
Australia, Western Australia | |
Sir Charles Gairdner Hospital | Recruiting |
Perth, Western Australia, Australia, 6009 | |
Contact: David Blacker, MBBS David.Blacker@health.wa.gov.au | |
Contact: Ellen Baker ellen.baker@health.wa.gov.au | |
Principal Investigator: David Blacker | |
Austria | |
Medizinische Universitat Innsbruck | Not yet recruiting |
Innsbruck, Austria, A-6020 | |
Contact: Erich Schmutzhard +43 512 23853 erich.schmutzhard@i-med.ac.at | |
Principal Investigator: Erich Schmutzhard | |
Landesklinikum Donauregion Tulln | Not yet recruiting |
Tulln, Austria, 3430 | |
Contact: Michael Brainin 43 (0) 2272 601 10721 michael.brainin@donau-uni.ac.at | |
Principal Investigator: Michael Brainin | |
Allgemeines Krankenhaus Linz | Not yet recruiting |
Linz, Austria, 4020 | |
Contact: Franz Gruber + 43 732 7806 6815 franz.gruber@akh.linz.at | |
Principal Investigator: Franz Gruber | |
Krankenhaus Barmherzige Bruder | Not yet recruiting |
Vienna, Austria, A-1020 | |
Contact: Wilfried Lang + 43 (0) 1-21121-3241 wilfried.lang@bbwien.at | |
Principal Investigator: Wilfried Lang | |
China | |
Regional Coordinating and Monitoring Centre: Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai Institute of Hypertension, Shanghai Second Medical University | Recruiting |
Shanghai, China, 200025 | |
Contact: Jiguang Wang, Professor +86 21 64662193 | |
Principal Investigator: Jiguang Wang, Professor | |
Regional Coordinating Centre China: The George Institute China | Recruiting |
Beijing, China, 100088 | |
Contact: Jian Sun +86 1082800577 ext 205 sjian@george.org | |
Principal Investigator: Yinging Huang, PhD | |
France | |
Regional Coordinating Centre Europe: Hospital Lariboisiere | Not yet recruiting |
Paris, France, 75475 | |
Contact: Serge Merchand +33 1 4995 6946 | |
Principal Investigator: Christian Stapf | |
India, Andhra Pradesh | |
Regional Coordinating Centre India: The George Institute India | Not yet recruiting |
Hyderabad, Andhra Pradesh, India, 500 033 | |
Contact: Hemalata Boyini +914023558091 ext 205 h.boyini@george.org.in | |
Principal Investigator: Subash Kaul |
Principal Investigator: | Craig Anderson, PhD | The George Institute |
Responsible Party: | The George Institute for International Health ( Porfessor Craig Anderson ) |
Study ID Numbers: | NHMRC-571281 |
Study First Received: | July 14, 2008 |
Last Updated: | March 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00716079 History of Changes |
Health Authority: | Australia: National Health and Medical Research Council |
Cerebral Hemorrhage Stroke antihypertensive drugs blood pressure |
disability clinical trial outcomes |
Vasodilator Agents Neurotransmitter Agents Cerebral Hemorrhage Cerebral Infarction Adrenergic Agents Hydralazine Intracranial Hemorrhages Brain Diseases Hemorrhage Cerebrovascular Disorders Urapidil Labetalol Enalapril Adrenergic beta-Antagonists Anti-Arrhythmia Agents |
Stroke Clonidine Vascular Diseases Central Nervous System Diseases Adrenergic alpha-Antagonists Cardiovascular Agents Metoprolol Antihypertensive Agents Phentolamine Glycerol Enalaprilat Esmolol Metoprolol succinate Adrenergic Antagonists Peripheral Nervous System Agents |
Vasodilator Agents Cerebral Hemorrhage Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Hydralazine Physiological Effects of Drugs Intracranial Hemorrhages Brain Diseases Hemorrhage Cerebrovascular Disorders Labetalol Pathologic Processes Therapeutic Uses Adrenergic beta-Antagonists |
Cardiovascular Diseases Anti-Arrhythmia Agents Sympatholytics Nervous System Diseases Stroke Vascular Diseases Central Nervous System Diseases Adrenergic alpha-Antagonists Cardiovascular Agents Antihypertensive Agents Metoprolol Pharmacologic Actions Phentolamine Autonomic Agents Adrenergic Antagonists |