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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
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Craig Anderson, The George Institute

Tracking Information
First Submitted Date  ICMJE July 14, 2008
First Posted Date  ICMJE July 16, 2008
Results First Submitted Date  ICMJE August 21, 2013
Results First Posted Date  ICMJE October 28, 2013
Last Update Posted Date December 13, 2013
Study Start Date  ICMJE September 2008
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2013)		 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 14, 2008)		 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2013)		 Death at 90 Days [ Time Frame: 90 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2008)		 death and dependency in patients treated <4 hours; death; dependency; HRQoL; physical function; recurrent vascular events; days of hospitalisation; permanent residential care [ Time Frame: 90 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial
Official Title  ICMJE An International Randomised Controlled Trial to Establish the Effects of Early Intensive Blood Pressure Lowering in Patients With Intracerebral Haemorrhage.
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Intracerebral Hemorrhage
  • Stroke
  • Hypertension
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Other: Blood pressure management policies
  • 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.
    Intervention: Other: Blood pressure management policies
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 21, 2013)		 2839
Original Estimated Enrollment  ICMJE
 (submitted: July 14, 2008)		 2800
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Chile,   China,   Finland,   France,   Germany,   Hong Kong,   India,   Italy,   Pakistan,   Portugal,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00716079
Other Study ID Numbers  ICMJE NHMRC-571281
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Craig Anderson, The George Institute
Original Responsible Party Porfessor Craig Anderson, The George Institute for International Health
Current Study Sponsor  ICMJE The George Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Health and Medical Research Council, Australia
Investigators  ICMJE
Principal Investigator: Craig Anderson, PhD The George Institute
PRS Account The George Institute
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP