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

July 14, 2008
November 19, 2013
September 2008
December 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00716079 on ClinicalTrials.gov Archive Site
Death at 90 Days [ Time Frame: 90 days ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial
An International Randomised Controlled Trial to Establish the Effects of Early Intensive Blood Pressure Lowering in Patients With Intracerebral Haemorrhage.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Intracerebral Hemorrhage
  • Stroke
  • Hypertension
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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2839
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany,   Australia,   Belgium,   France,   Finland,   Spain,   Portugal,   Switzerland,   United States,   Italy,   Hong Kong,   China,   Argentina,   Brazil,   India,   United Kingdom,   Chile,   Pakistan
 
NCT00716079
NHMRC-571281
Yes
Craig Anderson, The George Institute
The George Institute
National Health and Medical Research Council, Australia
Principal Investigator: Craig Anderson, PhD The George Institute
The George Institute
November 2013

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