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The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial

Information source: The George Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Intracerebral Hemorrhage; Stroke; Hypertension

Intervention: Blood pressure management policies (Other)

Phase: N/A

Status: Completed

Sponsored by: The George Institute

Official(s) and/or principal investigator(s):
Craig Anderson, PhD, Principal Investigator, Affiliation: The George Institute


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.

Clinical Details

Official title: An International Randomised Controlled Trial to Establish the Effects of Early Intensive Blood Pressure Lowering in Patients With Intracerebral Haemorrhage.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome: Death at 90 Days

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

Regional Coordinating Centre Argentina, Buenos Aires, Argentina

University of Graz, Graz 8036, Austria

Medizinische Universitat Innsbruck, Innsbruck A-6020, Austria

Allgemeines Krankenhaus Linz, Linz 4020, Austria

AZ-VUB (University hospital Brussels), Jette 1090, Belgium

CHU Tivoli, La Louviere 7100, Belgium

Regional Coordinating Centre Brazil, Sao Paulo, Brazil

Regional Coordnating Centre Chile, Santiago, Chile

Regional Coordinating and Monitoring Centre: Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai Institute of Hypertension, Shanghai Second Medical University, Shanghai 200025, China

Helsinki University Central Hospital, Helsinki 00290, Finland

Hôpital Jean Minjoz, Besancon 25030, France

Hopital de la Cavale-Blanche, Brest 29609, France

Centre Hospitalier de Calais, Calais 62107, France

CHU Bicetre, Kremlin-Bicetre 94275, France

Hopital Roger Salengro, Lille 59037, France

Centre Hospitalier de Meaux, Meaux 77104, France

CHU Nantes - Hopital Laennec, Nantes 44093, France

Centre Hospitalier Sainte Anne, Paris 75014, France

Groupe Hospitalier Paris Saint-Joseph, Paris 75674, France

Hopital de Lariboisiere, Paris 75010, France

Hopital Tenon, Paris 75970, France

Hôpital de la Salpêtrière, Paris 75651, France

Regional Coordinating Centre Europe: Unite de recherche clinique Lariboisiere, Paris 75475, France

Hopital Delafontaine, Saint-Denis 27993, France

Centre Hospitalier de Versailles, Versailles 78157, France

Charite Campus Benjamin Franklin (CCBF), Berlin 12200, Germany

Universitatsklinikum Dresden, Dresden 01307, Germany

Heinrich-Heine-Universitat, Dusseldorf 40225, Germany

Universitat Erlangen-Nurnberg, Erlangen 91054, Germany

Klinikum Frankfurt, Frankfurt 15236, Germany

Universitatsklinikum Frankfurt, Frankfurt 60528, Germany

Martin-Luther-Universität, Halle 06120, Germany

Asklepios Klinik Altona, Hamburg 22763, Germany

Asklepios Klinik Barmbek, Hamburg 22291, Germany

Universitatsklinikum Hamburg-Eppendorf, Hamburg 20246, Germany

University of Heidelberg, Heidelberg 69120, Germany

Universitatsklinikum Mannheim, Mannheim 68167, Germany

Universitatsklinikum Ulm, Oberer Eselsberg, Ulm 89081, Germany

Prince of Wales Hospital, Sha Tin, Hong Kong

Ospedale di Citta di Castello, Citta di Castello 6012, Italy

The Aga Khan University Hospital, Karachi, Pakistan

Hospital de Sao Joao, Porto 4202-451, Portugal

Hospital General Universitario de Albacete, Albacete, Spain

Hospital Clinic Barcelona, Barcelona 08036, Spain

Hospital de Girona Dr. Josep Trueta, Girona 17007, Spain

Inselspital Neurologische Klinik, Bern 3010, Switzerland

Regional Coordinating Centre United Kingdom, Leicester, United Kingdom

Regional Coordinating Centre India: The George Institute India, Hyderabad, Andhra Pradesh 500 033, India

Canberra Hospital, Canberra, Australian Capital Territory 2605, Australia

Regional Coordinating Centre China: The George Institute China, Beijing, Beijing 100088, China

Mayo Clinic, Rochester, Minnesota 55905, United States

Concord Hospital, Concord, New South Wales 2138, Australia

Gosford Hospital, Gosford, New South Wales 2250, Australia

John Hunter Hospital, Newcastle, New South Wales 2310, Australia

Royal Prince Alfred Hospital, Sydney, New South Wales 2050, Australia

Royal Brisbane and Women's Hospital Health Service District, Brisbane, Queensland 4029, Australia

Austin Repatriation General Hospital, Melbourne, Victoria 3081, Australia

Box Hill Hospital, Melbourne, Victoria 3128, Australia

Monash Medical Centre, Melbourne, Victoria 3168, Australia

Royal Melbourne Hospital, Melbourne, Victoria 3050, Australia

Western Hospital, Melbourne, Victoria 3011, Australia

Sir Charles Gairdner Hospital, Perth, Western Australia 6009, Australia

Additional Information

Further information on INTERACT2 is available on the INTERACT2 trial website.

Related publications:

Anderson CS, Huang Y, Wang JG, Arima H, Neal B, Peng B, Heeley E, Skulina C, Parsons MW, Kim JS, Tao QL, Li YC, Jiang JD, Tai LW, Zhang JL, Xu E, Cheng Y, Heritier S, Morgenstern LB, Chalmers J; INTERACT Investigators. Intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT): a randomised pilot trial. Lancet Neurol. 2008 May;7(5):391-9. doi: 10.1016/S1474-4422(08)70069-3. Epub 2008 Apr 7.

Delcourt C, Huang Y, Wang J, Heeley E, Lindley R, Stapf C, Tzourio C, Arima H, Parsons M, Sun J, Neal B, Chalmers J, Anderson C; INTERACT2 Investigators. The second (main) phase of an open, randomised, multicentre study to investigate the effectiveness of an intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT2). Int J Stroke. 2010 Apr;5(2):110-6. doi: 10.1111/j.1747-4949.2010.00415.x.

Starting date: September 2008
Last updated: November 19, 2013

Page last updated: August 23, 2015

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