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Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage

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ClinicalTrials.gov Identifier: NCT00226096
Recruitment Status : Completed
First Posted : September 26, 2005
Last Update Posted : June 26, 2008
National Health and Medical Research Council, Australia
Information provided by:
The George Institute

Brief Summary:
The purpose of the study is to determine whether lowering high blood pressure levels after the start of a stroke caused by bleeding in the brain (intracerebral haemorrhage) will reduce the chances of a person dying or surviving with a long term disability. The study will be undertaken in two phases: a vanguard phase in 400 patients, to plan for a main phase in 2000 patients.

Condition or disease Intervention/treatment Phase
CVA (Cerebrovascular Accident) Cerebral Hemorrhage Intracranial Hemorrhages Drug: Labetalol Hydrochloride Drug: Metoprolol tartrate Drug: Hydralazine Hydrochloride Drug: Glycerol Trinitrate Drug: Phentolamine mesylate Drug: Nicardipine Drug: Urapidil Drug: Esmolol Drug: Clonidine Drug: Enalaprilat Drug: Nitroprusside Not Applicable

Detailed Description:

Intracerebral haemorrhage (ICH) is one of the most serious subtypes of stroke, affecting approximately 2-3 million people worldwide each year. About one third of people with ICH die early after onset and the majority of survivors are left with major long-term disability. Administration of activated recombinant human Factor VII has been shown to limit haematoma expansion in randomised controlled clinical trials; however, future clinical use of this agent may be limited by a short therapeutic time window, contraindication in patients at risk of thromboembolism and high cost. Currently, no acute medical therapies have been shown to alter outcome in ICH and the role of surgery remains uncertain.

Blood pressure (BP) levels are strongly and positively associated with the incidence of first and recurrent stroke and there is definite evidence that BP lowering reduces stroke risk. Although BP levels are commonly elevated after stroke onset, particularly in ICH, the effects of BP lowering treatment in the acute phase of stroke remain unknown.

The study aims to establish the effectiveness of a management policy of early intensive BP lowering on death & disability in patients with primary ICH compared to current guideline-based management of high BP in the clinical setting.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 404 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Trial to Establish the Effects of Early Intensive Blood Pressure Lowering on Death and Disability in Patients With Stroke Due to Acute Intracerebral Haemorrhage
Study Start Date : November 2005
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Primary Outcome Measures :
  1. Combination death and dependency, according to a 3-6 scores on the modified Rankin Score. [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. All cause and cause-specific early neurological deterioration during the first 72 hours; haematoma expansion & cerebral oedema at 24 & 72 hours; ; functional disability; cognitive function; quality of life; mortality at 1 and 3 months [ Time Frame: 24 and 72 hours, 1 and 3 months ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Aged 18 years or above
  • Acute stroke due to spontaneous ICH confirmed by clinical history & CT scan
  • At least 2 systolic BP measurements of >/=150mmHg and </=220mmHg, recorded 2 or more minutes apart
  • Able to commence randomly assigned BP lowering regimen within 6 hours of stroke onset
  • Able to be actively treated and admitted to a monitored facility e.g. HDU/ICU/acute stroke unit

Exclusion Criteria:

  • Known definite contraindication to an intensive BP lowering regimen
  • Known definite indication for intensive BP lowering regimen as (or more) intensive than the active treatment arm
  • Definite evidence that the ICH is secondary to a structural abnormality in the brain
  • 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
  • Known advanced dementia or significant pre-stroke disability
  • Concomitant medical illness that would interfere with outcome assessments and follow up
  • Already booked for surgical evacuation of haematoma
  • Previous participation in this trial or current participation in another investigational drug trial
  • A high likelihood that the patient will not adhere to the study treatment and follow up regimen

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): NCT00226096

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Sponsors and Collaborators
The George Institute
National Health and Medical Research Council, Australia
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Principal Investigator: Craig Anderson, PhD The George Institute
Principal Investigator: Bruce Neal, PhD The George Institute
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00226096    
Other Study ID Numbers: NDA1INTERACT
First Posted: September 26, 2005    Key Record Dates
Last Update Posted: June 26, 2008
Last Verified: June 2008
Keywords provided by The George Institute:
Clinical Trial
Blood Pressure
CVA (Cerebrovascular Accident)
Additional relevant MeSH terms:
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Intracranial Hemorrhages
Cerebral Hemorrhage
Pathologic Processes
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