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| Sponsor: | The George Institute |
|---|---|
| Collaborator: |
National Health and Medical Research Council, Australia |
| Information provided by: | The George Institute |
| ClinicalTrials.gov Identifier: | NCT00226096 |
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 |
| 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) |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |
| Principal Investigator: | Craig Anderson, PhD | The George Institute |
| Principal Investigator: | Bruce Neal, PhD | The George Institute |
More Information
| 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 |
|
Clinical Trial Blood Pressure CVA (Cerebrovascular Accident) |
|
Cerebral Hemorrhage Hemorrhage Cerebral Infarction Stroke Intracranial Hemorrhages Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Infarction Brain Ischemia Metoprolol |
Urapidil Clonidine Labetalol Enalaprilat Enalapril Hydralazine Nicardipine Nitroprusside Phentolamine Esmolol Metoprolol succinate Glycerol Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses |