Clinical trial NCT00716079: The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial
Official title: An International Randomised Controlled Trial to Establish the Effects of Early Intensive Blood Pressure Lowering in Patients With Intracerebral Haemorrhage.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracerebral Hemorrhage
Stroke
Hypertension
Keywords: Cerebral Hemorrhage
Stroke
antihypertensive drugs
blood pressure
disability
clinical trial
outcomes
Lead sponsor: The George Institute
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
First posted: 2008-07-16
Enrollment: 2839
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Intracerebral haemorrhage (ICH) is one of the most serious subtypes of stroke, affecting over a million people worldwide each year, most of whom live in Asia. About one third of people with ICH die early after onset and the majority of survivors are left with major long-term disability. Despite the magnitude of the disease burden and cost on healthcare resources, there remains uncertainty about the role of surgery for ICH and no acute medical therapies have been shown to definitely alter outcome in ICH.

The INTERACT2 study follows the recently completed initial pilot study vanguard phase) which established the feasibility of the protocol, safety of early intensive BP lowering, and effects on haematoma expansion within 6 hours of onset of ICH. Having established 'proof-of-concept' that BP lowering may improve outcome by reducing haematoma expansion, INTERACT2 aims to establish the effects of the treatment on major clinical endpoints in patients with ICH recruited from an expanding clinical network around the world.

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.

Primary outcomes:
measure: A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS)
timeFrame: 90 days
Secondary outcomes:
measure: Death at 90 Days
timeFrame: 90 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Buenos Aires
country: Argentina
facility: Regional Coordinating Centre Argentina
city: Canberra
country: Australia
facility: Canberra Hospital
state: Australian Capital Territory
city: Concord
country: Australia
facility: Concord Hospital
state: New South Wales
city: Gosford
country: Australia
facility: Gosford Hospital
state: New South Wales
city: Newcastle
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital Health Service District
state: Queensland
city: Melbourne
country: Australia
facility: Western Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Austin Repatriation General Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Perth
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Graz
country: Austria
facility: University of Graz
city: Innsbruck
country: Austria
facility: Medizinische Universitat Innsbruck
city: Linz
country: Austria
facility: Allgemeines Krankenhaus Linz
city: Jette
country: Belgium
facility: AZ-VUB (University hospital Brussels)
city: La Louviere
country: Belgium
facility: CHU Tivoli
city: Sao Paulo
country: Brazil
facility: Regional Coordinating Centre Brazil
city: Santiago
country: Chile
facility: Regional Coordnating Centre Chile
city: Beijing
country: China
facility: Regional Coordinating Centre China: The George Institute China
state: Beijing
city: Shanghai
country: China
facility: Regional Coordinating and Monitoring Centre: Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai Institute of Hypertension, Shanghai Second Medical University
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Besancon
country: France
facility: Hôpital Jean Minjoz
city: Brest
country: France
facility: Hopital de la Cavale-Blanche
city: Calais
country: France
facility: Centre Hospitalier de Calais
city: Kremlin-Bicetre
country: France
facility: CHU Bicetre
city: Lille
country: France
facility: Hopital Roger Salengro
city: Meaux
country: France
facility: Centre Hospitalier de Meaux
city: Nantes
country: France
facility: CHU Nantes - Hopital Laennec
city: Paris
country: France
facility: Hopital de Lariboisiere
city: Paris
country: France
facility: Centre Hospitalier Sainte Anne
city: Paris
country: France
facility: Regional Coordinating Centre Europe: Unite de recherche clinique Lariboisiere
city: Paris
country: France
facility: Hôpital de la Salpêtrière
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint-Joseph
city: Paris
country: France
facility: Hopital Tenon
city: Saint-Denis
country: France
facility: Hopital Delafontaine
city: Versailles
country: France
facility: Centre Hospitalier de Versailles
city: Berlin
country: Germany
facility: Charite Campus Benjamin Franklin (CCBF)
city: Dresden
country: Germany
facility: Universitatsklinikum Dresden
city: Dusseldorf
country: Germany
facility: Heinrich-Heine-Universitat
city: Erlangen
country: Germany
facility: Universitat Erlangen-Nurnberg
city: Frankfurt
country: Germany
facility: Klinikum Frankfurt
city: Frankfurt
country: Germany
facility: Universitatsklinikum Frankfurt
city: Halle
country: Germany
facility: Martin-Luther-Universität
city: Hamburg
country: Germany
facility: Universitatsklinikum Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Asklepios Klinik Barmbek
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Heidelberg
country: Germany
facility: University of Heidelberg
city: Mannheim
country: Germany
facility: Universitatsklinikum Mannheim
city: Ulm
country: Germany
facility: Universitatsklinikum Ulm, Oberer Eselsberg
city: Sha Tin
country: Hong Kong
facility: Prince of Wales Hospital
city: Hyderabad
country: India
facility: Regional Coordinating Centre India: The George Institute India
state: Andhra Pradesh
city: Citta di Castello
country: Italy
facility: Ospedale di Citta di Castello
city: Karachi
country: Pakistan
facility: The Aga Khan University Hospital
city: Porto
country: Portugal
facility: Hospital de Sao Joao
city: Albacete
country: Spain
facility: Hospital General Universitario de Albacete
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Girona
country: Spain
facility: Hospital de Girona Dr. Josep Trueta
city: Bern
country: Switzerland
facility: Inselspital Neurologische Klinik
city: Leicester
country: United Kingdom
facility: Regional Coordinating Centre United Kingdom
Study officials:
affiliation: The George Institute
name: Craig Anderson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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