Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00226096
Status:
COMPLETED
Last Update Posted:
2008-06-26
First Post:
2005-09-23
Brief Title:
Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage
Sponsor:
The George Institute
Organization:
The George Institute
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None