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

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00716079
Recruitment Status : Completed
First Posted : July 16, 2008
Results First Posted : October 28, 2013
Last Update Posted : December 13, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Intracerebral Hemorrhage Stroke Hypertension Other: Blood pressure management policies

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2839 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : September 2008
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Death at 90 Days [ Time Frame: 90 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00716079

  Hide Study Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
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
Western Hospital
Melbourne, Victoria, Australia, 3011
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Austin Repatriation General Hospital
Melbourne, Victoria, Australia, 3081
Box Hill Hospital
Melbourne, Victoria, Australia, 3128
Monash Medical Centre
Melbourne, Victoria, Australia, 3168
Australia, Western Australia
Sir Charles Gairdner Hospital
Perth, Western Australia, Australia, 6009
University of Graz
Graz, Austria, 8036
Medizinische Universitat Innsbruck
Innsbruck, Austria, A-6020
Allgemeines Krankenhaus Linz
Linz, Austria, 4020
AZ-VUB (University hospital Brussels)
Jette, Belgium, 1090
CHU Tivoli
La Louviere, Belgium, 7100
Regional Coordinating Centre Brazil
Sao Paulo, Brazil
Regional Coordnating Centre Chile
Santiago, Chile
China, Beijing
Regional Coordinating Centre China: The George Institute China
Beijing, Beijing, China, 100088
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
Helsinki University Central Hospital
Helsinki, Finland, 00290
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
Hopital de Lariboisiere
Paris, France, 75010
Centre Hospitalier Sainte Anne
Paris, France, 75014
Regional Coordinating Centre Europe: Unite de recherche clinique Lariboisiere
Paris, France, 75475
Hôpital de la Salpêtrière
Paris, France, 75651
Groupe Hospitalier Paris Saint-Joseph
Paris, France, 75674
Hopital Tenon
Paris, France, 75970
Hopital Delafontaine
Saint-Denis, France, 27993
Centre Hospitalier de Versailles
Versailles, France, 78157
Charite Campus Benjamin Franklin (CCBF)
Berlin, Germany, 12200
Universitatsklinikum Dresden
Dresden, Germany, 01307
Dusseldorf, Germany, 40225
Universitat Erlangen-Nurnberg
Erlangen, Germany, 91054
Klinikum Frankfurt
Frankfurt, Germany, 15236
Universitatsklinikum Frankfurt
Frankfurt, Germany, 60528
Halle, Germany, 06120
Universitatsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Asklepios Klinik Barmbek
Hamburg, Germany, 22291
Asklepios Klinik Altona
Hamburg, Germany, 22763
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
Regional Coordinating Centre India: The George Institute India
Hyderabad, Andhra Pradesh, India, 500 033
Ospedale di Citta di Castello
Citta di Castello, Italy, 6012
The Aga Khan University Hospital
Karachi, Pakistan
Hospital de Sao Joao
Porto, Portugal, 4202-451
Hospital General Universitario de Albacete
Albacete, Spain
Hospital Clinic Barcelona
Barcelona, Spain, 08036
Hospital de Girona Dr. Josep Trueta
Girona, Spain, 17007
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
Principal Investigator: Craig Anderson, PhD The George Institute
More Information

Additional Information:
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
First Posted: July 16, 2008    Key Record Dates
Results First Posted: October 28, 2013
Last Update Posted: December 13, 2013
Last Verified: November 2013

Keywords provided by Craig Anderson, The George Institute:
Cerebral Hemorrhage
antihypertensive drugs
blood pressure
clinical trial

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