Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT2)

This study has been completed.
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Craig Anderson, The George Institute
ClinicalTrials.gov Identifier:
NCT00716079
First received: July 14, 2008
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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
Intracerebral Hemorrhage
Stroke
Hypertension
Other: Blood pressure management policies

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An International Randomised Controlled Trial to Establish the Effects of Early Intensive Blood Pressure Lowering in Patients With Intracerebral Haemorrhage.

Resource links provided by NLM:


Further study details as provided by The George Institute:

Primary Outcome Measures:
  • A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS) [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Death at 90 Days [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Enrollment: 2839
Study Start Date: September 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: 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.
Other Names:
  • Labetalol Hydrochloride
  • Metoprolol tartrate
  • Hydralazine Hydrochloride
  • Glycerol Trinitrate
  • Phentolamine mesylate
  • Nicardipine
  • Urapidil
  • Esmolol
  • Clonidine
  • Enalaprilat
  • Niroprusside
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: 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.
Other Names:
  • Labetalol Hydrochloride
  • Metoprolol tartrate
  • Hydralazine Hydrochloride
  • Glycerol Trinitrate
  • Phentolamine mesylate
  • Nicardipine
  • Urapidil
  • Esmolol
  • Clonidine
  • Enalaprilat
  • Niroprusside

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00716079

  Hide Study Locations
Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Argentina
Regional Coordinating Centre Argentina
Buenos Aires, Argentina
Australia, Australian Capital Territory
Canberra Hospital
Canberra, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Concord Hospital
Concord, New South Wales, Australia, 2138
Gosford Hospital
Gosford, New South Wales, Australia, 2250
John Hunter Hospital
Newcastle, New South Wales, Australia, 2310
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
Australia, Queensland
Royal Brisbane and Women's Hospital Health Service District
Brisbane, Queensland, Australia, 4029
Australia, Victoria
Austin Repatriation General Hospital
Melbourne, Victoria, Australia, 3081
Box Hill Hospital
Melbourne, Victoria, Australia, 3128
Monash Medical Centre
Melbourne, Victoria, Australia, 3168
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Western Hospital
Melbourne, Victoria, Australia, 3011
Australia, Western Australia
Sir Charles Gairdner Hospital
Perth, Western Australia, Australia, 6009
Austria
University of Graz
Graz, Austria, 8036
Medizinische Universitat Innsbruck
Innsbruck, Austria, A-6020
Allgemeines Krankenhaus Linz
Linz, Austria, 4020
Belgium
AZ-VUB (University hospital Brussels)
Jette, Belgium, 1090
CHU Tivoli
La Louviere, Belgium, 7100
Brazil
Regional Coordinating Centre Brazil
Sao Paulo, Brazil
Chile
Regional Coordnating Centre Chile
Santiago, Chile
China, Beijing
Regional Coordinating Centre China: The George Institute China
Beijing, Beijing, China, 100088
China
Regional Coordinating and Monitoring Centre: Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai Institute of Hypertension, Shanghai Second Medical University
Shanghai, China, 200025
Finland
Helsinki University Central Hospital
Helsinki, Finland, 00290
France
Hôpital Jean Minjoz
Besancon, France, 25030
Hopital de la Cavale-Blanche
Brest, France, 29609
Centre Hospitalier de Calais
Calais, France, 62107
CHU Bicetre
Kremlin-Bicetre, France, 94275
Hopital Roger Salengro
Lille, France, 59037
Centre Hospitalier de Meaux
Meaux, France, 77104
CHU Nantes - Hopital Laennec
Nantes, France, 44093
Centre Hospitalier Sainte Anne
Paris, France, 75014
Groupe Hospitalier Paris Saint-Joseph
Paris, France, 75674
Hopital de Lariboisiere
Paris, France, 75010
Hopital Tenon
Paris, France, 75970
Hôpital de la Salpêtrière
Paris, France, 75651
Regional Coordinating Centre Europe: Unite de recherche clinique Lariboisiere
Paris, France, 75475
Hopital Delafontaine
Saint-Denis, France, 27993
Centre Hospitalier de Versailles
Versailles, France, 78157
Germany
Charite Campus Benjamin Franklin (CCBF)
Berlin, Germany, 12200
Universitatsklinikum Dresden
Dresden, Germany, 01307
Heinrich-Heine-Universitat
Dusseldorf, Germany, 40225
Universitat Erlangen-Nurnberg
Erlangen, Germany, 91054
Klinikum Frankfurt
Frankfurt, Germany, 15236
Universitatsklinikum Frankfurt
Frankfurt, Germany, 60528
Martin-Luther-Universität
Halle, Germany, 06120
Asklepios Klinik Altona
Hamburg, Germany, 22763
Asklepios Klinik Barmbek
Hamburg, Germany, 22291
Universitatsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
University of Heidelberg
Heidelberg, Germany, 69120
Universitatsklinikum Mannheim
Mannheim, Germany, 68167
Universitatsklinikum Ulm, Oberer Eselsberg
Ulm, Germany, 89081
Hong Kong
Prince of Wales Hospital
Sha Tin, Hong Kong
India
Regional Coordinating Centre India: The George Institute India
Hyderabad, Andhra Pradesh, India, 500 033
Italy
Ospedale di Citta di Castello
Citta di Castello, Italy, 6012
Pakistan
The Aga Khan University Hospital
Karachi, Pakistan
Portugal
Hospital de Sao Joao
Porto, Portugal, 4202-451
Spain
Hospital General Universitario de Albacete
Albacete, Spain
Hospital Clinic Barcelona
Barcelona, Spain, 08036
Hospital de Girona Dr. Josep Trueta
Girona, Spain, 17007
Switzerland
Inselspital Neurologische Klinik
Bern, Switzerland, 3010
United Kingdom
Regional Coordinating Centre United Kingdom
Leicester, United Kingdom
Sponsors and Collaborators
The George Institute
National Health and Medical Research Council, Australia
Investigators
Principal Investigator: Craig Anderson, PhD The George Institute
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Craig Anderson, Senior Director, Neurological and Mental Health Division, The George Institute
ClinicalTrials.gov Identifier: NCT00716079     History of Changes
Other Study ID Numbers: NHMRC-571281
Study First Received: July 14, 2008
Results First Received: August 21, 2013
Last Updated: November 19, 2013
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by The George Institute:
Cerebral Hemorrhage
Stroke
antihypertensive drugs
blood pressure
disability
clinical trial
outcomes

Additional relevant MeSH terms:
Cerebral Hemorrhage
Hemorrhage
Hypertension
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Hemorrhages
Nervous System Diseases
Pathologic Processes
Vascular Diseases
Hydralazine
Labetalol
Adrenergic Agents
Adrenergic Antagonists
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic beta-Antagonists
Antihypertensive Agents
Autonomic Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympathomimetics
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 25, 2014