Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage

This study has been completed.
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by:
The George Institute
ClinicalTrials.gov Identifier:
NCT00226096
First received: September 23, 2005
Last updated: June 25, 2008
Last verified: June 2008
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by The George Institute:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 404
Study Start Date: November 2005
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00226096

Locations
Australia, New South Wales
Concord Hospital
Concord, New South Wales, Australia, 2138
Gosford Hospital
Gosford, New South Wales, Australia, 2250
St George Hospital
Kogarah, New South Wales, Australia, 2217
John Hunter Hospital
Newcastle, New South Wales, Australia, 2310
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
St Vincent's Hospital
Sydney, New South Wales, Australia, 2010
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Box Hill Hospital
Melbourne, Victoria, Australia, 3128
Austin Health
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Alfred Hospital
Melbourne, Victoria, Australia, 3181
St Vincent's Hospital
Melbourne, Victoria, Australia, 3065
Monash Medical Centre
Melbourne, Victoria, Australia
Australia, Western Australia
Sir Charles Gairdner Hospital
Perth, Western Australia, Australia, 6009
China
Hospitals in China, c/o The George Institute China
Beijing, China
Regional Coordinating Centre: Peking University First Hospital
Beijing, China, 100034
Regional Coordinating Centre: Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai Institute of Hypertension, Shanghai Second Medical University
Shanghai, China, 200025
New Zealand
North Shore Hospital
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Sponsors and Collaborators
The George Institute
National Health and Medical Research Council, Australia
Investigators
Principal Investigator: Craig Anderson, PhD The George Institute
Principal Investigator: Bruce Neal, PhD The George Institute
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00226096     History of Changes
Other Study ID Numbers: NDA1INTERACT
Study First Received: September 23, 2005
Last Updated: June 25, 2008
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Health Research Council

Keywords provided by The George Institute:
Clinical Trial
Blood Pressure
CVA (Cerebrovascular Accident)

Additional relevant MeSH terms:
Hemorrhage
Cerebral Infarction
Stroke
Intracranial Hemorrhages
Cerebral Hemorrhage
Pathologic Processes
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Metoprolol
Hydralazine
Nitroprusside
Phentolamine
Labetalol
Metoprolol succinate
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists

ClinicalTrials.gov processed this record on September 18, 2014