The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial.
- Conditions
- Health Condition 1: null- Intracerebral Haemorrhage Stroke HypertensionHealth Condition 2: G998- Other specified disorders of nervous system in diseases classified elsewhere
- Registration Number
- CTRI/2009/091/000052
- Lead Sponsor
- The National Health and Medical Research Council NHMRC of Australia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2839
1.Patient older than 18 years old (there is no upper age limit).
2.Acute stroke syndrome due to spontaneous ICH, confirmed by clinical history and CT scan
3.At least two systolic BP measurements of more than or equal to 150 mmHg and less than or equal to 220 mmHg, recorded 2 or more minutes apart.
4.Able to commence randomly assigned BP lowering regimen within 6 hours of stroke onset.
5.Able to be â??activelyâ?? treated and admitted to a monitored facility
1.Clear indication or contraindication to intensive BP lowering.
2.Evidence ICH secondary to a structural abnormality
3.Recent (within 1 month) use of a thrombolytic agent
4.Previous ischaemic stroke within 30 days
5.A very high likelihood that the patient will die within the next 24 hours on the basis of clinical and/or radiological criteria
6.Score of 3-5 on the Glasgow Coma Scale (indicating deep coma)
7.Significant pre-stroke disability or advanced dementia
8.Planned early neurological intervention
9.Participation in another clinical trial.
10.A high likelihood that the patient will not adhere to the study treatment and follow-up regimen.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Measure: A composite of death or dependency, with dependency being defined by a score of 3 to 5 on the modified Rankin Scale (mRS) <br/ ><br>Timepoint: Time Frame: 90 days <br/ ><br>
- Secondary Outcome Measures
Name Time Method To assess the effect of the treatment on the primary outcome in a subgroup of patients who receive treatment within 4 hours of ICH onset. <br/ ><br>Other secondary outcomes <br/ ><br>1.Mortality, Dependency(measured by mRS)& HRQoL (measured by the EuroQuol5D) at Day 28&90 <br/ ><br>4.Recurrent stroke <br/ ><br>5.Acute myocardial infarction (or sudden death) from a cardiovascular cause <br/ ><br>6.Need for permanent residential care <br/ ><br>7.Duration of initial hospital stayTimepoint: 1.Mortality at 28 days and 90 days <br/ ><br>2.Dependency (measured by mRS) at 28 days and 90 days <br/ ><br>3.HRQoL (measured by the EuroQuol 5D) at 28 days and 90 days. <br/ ><br>4.Recurrent stroke after 24 hours of the initial ICH. <br/ ><br>5.Acute myocardial infarction (or sudden death) from a cardiovascular cause, according to standard definitions. <br/ ><br>6.Need for permanent residential care <br/ ><br>7.Duration of initial hospital stay