The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial

Not Applicable

Completed

• Conditions: Hypertension; Stroke; Intracerebral Hemorrhage
• Interventions: Other: Blood pressure management policies

• Registration Number: NCT00716079
• Lead Sponsor: The George Institute

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.

Study Timeline

• Study First Submitted: 2008-07-14
• Study First Submitted QC: 2008-07-14
• Study First Posted: 2008-07-16
• Study Start: 2008-09
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2013-08-21
• Results First Submitted QC: 2013-08-21
• Results First Posted: 2013-10-28
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-19
• Last Update Posted: 2013-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2839

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive BP lowering	Blood pressure management policies	Management policy to lower the systolic Blood pressure (BP) to a target of 140mmHg within 1 hour of randomization and sustained for 24 hours. Sites were provided with protocols for different intravenous agents and used whichever routinely available drugs were in their hospital.
Guideline recommended BP lowering	Blood pressure management policies	Patients received management of BP based on the standard guidelines at the time, as published by the American Heart Association (AHA) in 2007 and 2010. The attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, intravenous treatment may be started until the target systolic BP of 180 mmHg is achieved.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Death at 90 Days	90 days

Trial Locations

Locations (62)

Hopital de Lariboisiere; 🇫🇷 Paris, France

Regional Coordinating Centre Brazil; 🇧🇷 Sao Paulo, Brazil

Regional Coordinating Centre China: The George Institute China; 🇨🇳 Beijing, Beijing, China

AZ-VUB (University hospital Brussels); 🇧🇪 Jette, Belgium

Royal Melbourne Hospital; 🇦🇺 Melbourne, Victoria, Australia

Box Hill Hospital; 🇦🇺 Melbourne, Victoria, Australia

Sir Charles Gairdner Hospital; 🇦🇺 Perth, Western Australia, Australia

Regional Coordnating Centre Chile; 🇨🇱 Santiago, Chile

Charite Campus Benjamin Franklin (CCBF); 🇩🇪 Berlin, Germany

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland

Austin Repatriation General Hospital; 🇦🇺 Melbourne, Victoria, Australia

Hopital de la Cavale-Blanche; 🇫🇷 Brest, France

CHU Tivoli; 🇧🇪 La Louviere, Belgium

Canberra Hospital; 🇦🇺 Canberra, Australian Capital Territory, Australia

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Concord Hospital; 🇦🇺 Concord, New South Wales, Australia

Regional Coordinating Centre Argentina; 🇦🇷 Buenos Aires, Argentina

Gosford Hospital; 🇦🇺 Gosford, New South Wales, Australia

John Hunter Hospital; 🇦🇺 Newcastle, New South Wales, Australia

Royal Brisbane and Women's Hospital Health Service District; 🇦🇺 Brisbane, Queensland, Australia

Western Hospital; 🇦🇺 Melbourne, Victoria, Australia

Hôpital Jean Minjoz; 🇫🇷 Besancon, France

CHU Bicetre; 🇫🇷 Kremlin-Bicetre, France

Centre Hospitalier de Calais; 🇫🇷 Calais, France

Hopital Roger Salengro; 🇫🇷 Lille, France

CHU Nantes - Hopital Laennec; 🇫🇷 Nantes, France

Regional Coordinating Centre Europe: Unite de recherche clinique Lariboisiere; 🇫🇷 Paris, France

Hôpital de la Salpêtrière; 🇫🇷 Paris, France

Groupe Hospitalier Paris Saint-Joseph; 🇫🇷 Paris, France

Hopital Delafontaine; 🇫🇷 Saint-Denis, France

Hopital Tenon; 🇫🇷 Paris, France

Centre Hospitalier de Versailles; 🇫🇷 Versailles, France

Heinrich-Heine-Universitat; 🇩🇪 Dusseldorf, Germany

Universitatsklinikum Dresden; 🇩🇪 Dresden, Germany

Universitat Erlangen-Nurnberg; 🇩🇪 Erlangen, Germany

Klinikum Frankfurt; 🇩🇪 Frankfurt, Germany

Martin-Luther-Universität; 🇩🇪 Halle, Germany

Universitatsklinikum Frankfurt; 🇩🇪 Frankfurt, Germany

Universitatsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Universitatsklinikum Mannheim; 🇩🇪 Mannheim, Germany

Asklepios Klinik Barmbek; 🇩🇪 Hamburg, Germany

Asklepios Klinik Altona; 🇩🇪 Hamburg, Germany

University of Heidelberg; 🇩🇪 Heidelberg, Germany

Universitatsklinikum Ulm, Oberer Eselsberg; 🇩🇪 Ulm, Germany

The Aga Khan University Hospital; 🇵🇰 Karachi, Pakistan

Ospedale di Citta di Castello; 🇮🇹 Citta di Castello, Italy

Hospital General Universitario de Albacete; 🇪🇸 Albacete, Spain

Regional Coordinating Centre United Kingdom; 🇬🇧 Leicester, United Kingdom

Hospital de Girona Dr. Josep Trueta; 🇪🇸 Girona, Spain

Hospital Clinic Barcelona; 🇪🇸 Barcelona, Spain

Royal Prince Alfred Hospital; 🇦🇺 Sydney, New South Wales, Australia

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

Hospital de Sao Joao; 🇵🇹 Porto, Portugal

University of Graz; 🇦🇹 Graz, Austria

Regional Coordinating Centre India: The George Institute India; 🇮🇳 Hyderabad, Andhra Pradesh, India

Medizinische Universitat Innsbruck; 🇦🇹 Innsbruck, Austria

Allgemeines Krankenhaus Linz; 🇦🇹 Linz, Austria

Inselspital Neurologische Klinik; 🇨🇭 Bern, Switzerland

Centre Hospitalier Sainte Anne; 🇫🇷 Paris, France

Centre Hospitalier de Meaux; 🇫🇷 Meaux, France

Monash Medical Centre; 🇦🇺 Melbourne, Victoria, Australia

Prince of Wales Hospital; 🇭🇰 Sha Tin, Hong Kong