The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial

Stroke Clinical Trial

— INTERACT2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00716079
• Other study ID #: NHMRC-571281
• Status: Completed
• Phase: N/A
• First received: July 14, 2008
• Last updated: November 19, 2013
• Start date: September 2008
• Est. completion date: December 2012

Study information

• Verified date: November 2013
• Source: The George Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2839
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Hypertension
• Intracerebral Hemorrhage
• Stroke

Intervention

Other:
• Blood pressure management policies
The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
The George Institute	National Health and Medical Research Council, Australia

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Chile,  China,  Finland,  France,  Germany,  Hong Kong,  India,  Italy,  Pakistan,  Portugal,  Spain,  Switzerland,  United Kingdom, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS)		90 days	Yes
Secondary	Death at 90 Days		90 days	No

External Links

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