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| Tracking Information | |||||||||
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| First Received Date ICMJE | September 23, 2005 | ||||||||
| Last Updated Date | June 25, 2008 | ||||||||
| Start Date ICMJE | November 2005 | ||||||||
| Primary Completion Date | September 2007 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Combination death and dependency, according to a 3-6 scores on the modified Rankin Score. [ Time Frame: 3 months ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Combination death and dependency, according to a 3-5 score on the mRS, at 3 months | ||||||||
| Change History | Complete list of historical versions of study NCT00226096 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
All cause and cause-specific easrly neurological deterioration during the first 72 hours; haematoma expansion at 24 and 72 hours; cerebral odema; functional disability at 7 days, 1 and 3 months; cognitive function at 1 and 3 months; HRQoL | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage | ||||||||
| Official Title ICMJE | 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 | ||||||||
| 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. |
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| 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 Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||
| Publications * | Anderson CS, Huang Y, Wang JG, Arima H, Neal B, Peng B, Heeley E, Skulina C, Parsons MW, Kim JS, Tao QL, Li YC, Jiang JD, Tai LW, Zhang JL, Xu E, Cheng Y, Heritier S, Morgenstern LB, Chalmers J; INTERACT Investigators. Intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT): a randomised pilot trial. Lancet Neurol. 2008 May;7(5):391-9. Epub 2008 Apr 7. | ||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 404 | ||||||||
| Completion Date | September 2007 | ||||||||
| Primary Completion Date | September 2007 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Australia, China, New Zealand | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00226096 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | NDA1INTERACT | ||||||||
| Study Sponsor ICMJE | The George Institute | ||||||||
| Collaborators ICMJE | National Health and Medical Research Council, Australia | ||||||||
| Investigators ICMJE |
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| Information Provided By | The George Institute | ||||||||
| Verification Date | June 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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