N/A N=2,839 Randomized Treatment

The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial

Intracerebral Hemorrhage · Stroke · Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT00716079 ↗

Enrolled (actual)

2,839

Serious AEs

23.1%

Results posted

Oct 2013

Primary outcome: Primary: A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS) — 719; 785 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Blood pressure management policies (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The George Institute
Primary completion: Dec 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS)	719; 785	—
SECONDARY Death at 90 Days	166; 170	—

Summary

The purpose of this academic lead study is to determine if a treatment strategy of early intensive blood pressure (BP) lowering compared to conservative BP lowering policy in patients with elevated blood pressure within 6 hours of acute intracerebral haemorrhage (ICH) improves the outcome of death and disability at 3 months after onset.

Eligibility Criteria

Inclusion Criteria

Patients with CT-confirmed spontaneous Intracerebral Haemorrhage (ICH)
Elevated systolic blood pressure (>150mmHg and <220mmHg)
Capacity to commence randomly assigned treatment within 6 hours of onset of ICH.
Able to be 'actively' treated and admitted to a monitored facility

Exclusion Criteria

Clear indication or contraindication to intensive BP lowering.
Evidence ICH secondary to a structural abnormality
Use of thrombolytic agent
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
Score of 3-5 on the Glasgow Coma Scale (indicating deep coma)
Significant pre-stroke disability or advanced dementia
Planned early neurological intervention
Participation in another clinical trial.
A high likelihood that the patient will not adhere to the study treatment and follow-up regimen.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00716079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.