The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial

Completed · Not applicable

Conditions studied: Intracerebral Hemorrhage, Stroke, Hypertension

In brief

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.

Key facts

Study ID

NCT00716079

Run by

The George Institute

People needed

2839

Starts

2008-09-01

Expected to finish

2012-12-01

Last updated by the study team

2013-12-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Regional Coordinating Centre Argentina — Buenos Aires, Argentina
• Canberra Hospital — Canberra, Australian Capital Territory, Australia
• Concord Hospital — Concord, New South Wales, Australia
• Gosford Hospital — Gosford, New South Wales, Australia
• John Hunter Hospital — Newcastle, New South Wales, Australia
• Royal Prince Alfred Hospital — Sydney, New South Wales, Australia
• Royal Brisbane and Women's Hospital Health Service District — Brisbane, Queensland, Australia
• Western Hospital — Melbourne, Victoria, Australia
• Royal Melbourne Hospital — Melbourne, Victoria, Australia
• Austin Repatriation General Hospital — Melbourne, Victoria, Australia
• Box Hill Hospital — Melbourne, Victoria, Australia
• Monash Medical Centre — Melbourne, Victoria, Australia
• Sir Charles Gairdner Hospital — Perth, Western Australia, Australia
• University of Graz — Graz, Austria
• Medizinische Universitat Innsbruck — Innsbruck, Austria
• Allgemeines Krankenhaus Linz — Linz, Austria
• AZ-VUB (University hospital Brussels) — Jette, Belgium
• CHU Tivoli — La Louvière, Belgium
• Regional Coordinating Centre Brazil — São Paulo, Brazil
• Regional Coordnating Centre Chile — Santiago, Chile
• Regional Coordinating Centre China: The George Institute China — Beijing, Beijing Municipality, China
• Regional Coordinating and Monitoring Centre: Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai Institute of Hypertension, Shanghai Second Medical University — Shanghai, China
• Helsinki University Central Hospital — Helsinki, Finland
• Hôpital Jean Minjoz — Besançon, France
• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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