The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT2)

November 19, 2013 updated by: Craig Anderson, The George Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2839

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Regional Coordinating Centre Argentina
  • Australia
    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australia, 2605
        • Canberra Hospital
    • New South Wales
      • Concord, New South Wales, Australia, 2138
        • Concord Hospital
      • Gosford, New South Wales, Australia, 2250
        • Gosford Hospital
      • Newcastle, New South Wales, Australia, 2310
        • John Hunter Hospital
      • Sydney, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital Health Service District
    • Victoria
      • Melbourne, Victoria, Australia, 3168
        • Monash Medical Centre
      • Melbourne, Victoria, Australia, 3050
        • Royal Melbourne Hospital
      • Melbourne, Victoria, Australia, 3128
        • Box Hill Hospital
      • Melbourne, Victoria, Australia, 3011
        • Western Hospital
      • Melbourne, Victoria, Australia, 3081
        • Austin Repatriation General Hospital
    • Western Australia
      • Perth, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital
  • Austria
      • Graz, Austria, 8036
        • University of Graz
      • Innsbruck, Austria, A-6020
        • Medizinische Universität Innsbruck
      • Linz, Austria, 4020
        • Allgemeines Krankenhaus Linz
  • Belgium
      • Jette, Belgium, 1090
        • AZ-VUB (University hospital Brussels)
      • La Louviere, Belgium, 7100
        • Chu Tivoli
  • Brazil
      • Sao Paulo, Brazil
        • Regional Coordinating Centre Brazil
  • Chile
      • Santiago, Chile
        • Regional Coordnating Centre Chile
  • China
      • Shanghai, China, 200025
        • Regional Coordinating and Monitoring Centre: Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai Institute of Hypertension, Shanghai Second Medical University
    • Beijing
      • Beijing, Beijing, China, 100088
        • Regional Coordinating Centre China: The George Institute China
  • Finland
      • Helsinki, Finland, 00290
        • Helsinki University Central Hospital
  • France
      • Besancon, France, 25030
        • Hopital Jean Minjoz
      • Brest, France, 29609
        • Hopital de la Cavale-Blanche
      • Calais, France, 62107
        • Centre Hospitalier de Calais
      • Kremlin-Bicetre, France, 94275
        • CHU Bicêtre
      • Lille, France, 59037
        • Hopital Roger Salengro
      • Meaux, France, 77104
        • Centre Hospitalier de Meaux
      • Nantes, France, 44093
        • CHU NANTES - Hôpital Laënnec
      • Paris, France, 75970
        • Hopital Tenon
      • Paris, France, 75010
        • Hôpital de Lariboisière
      • Paris, France, 75014
        • Centre hospitalier Sainte Anne
      • Paris, France, 75475
        • Regional Coordinating Centre Europe: Unite de recherche clinique Lariboisiere
      • Paris, France, 75651
        • Hôpital de la Salpétrière
      • Paris, France, 75674
        • Groupe Hospitalier Paris Saint-Joseph
      • Saint-Denis, France, 27993
        • Hôpital Delafontaine
      • Versailles, France, 78157
        • Centre Hospitalier de Versailles
  • Germany
      • Berlin, Germany, 12200
        • Charite Campus Benjamin Franklin (CCBF)
      • Dresden, Germany, 01307
        • Universitätsklinikum Dresden
      • Dusseldorf, Germany, 40225
        • Heinrich-Heine-Universität
      • Erlangen, Germany, 91054
        • Universität Erlangen-Nurnberg
      • Frankfurt, Germany, 15236
        • Klinikum Frankfurt
      • Frankfurt, Germany, 60528
        • Universitatsklinikum Frankfurt
      • Halle, Germany, 06120
        • Martin-Luther-Universität
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf
      • Hamburg, Germany, 22291
        • Asklepios Klinik Barmbek
      • Hamburg, Germany, 22763
        • Asklepios Klinik Altona
      • Heidelberg, Germany, 69120
        • University of Heidelberg
      • Mannheim, Germany, 68167
        • Universitätsklinikum Mannheim
      • Ulm, Germany, 89081
        • Universitatsklinikum Ulm, Oberer Eselsberg
  • Hong Kong
      • Sha Tin, Hong Kong
        • Prince of Wales Hospital
  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500 033
        • Regional Coordinating Centre India: The George Institute India
  • Italy
      • Citta di Castello, Italy, 6012
        • Ospedale di Citta di Castello
  • Pakistan
      • Karachi, Pakistan
        • The Aga Khan University Hospital
  • Portugal
      • Porto, Portugal, 4202-451
        • Hospital de Sao Joao
  • Spain
      • Albacete, Spain
        • Hospital General Universitario de Albacete
      • Barcelona, Spain, 08036
        • Hospital Clinic Barcelona
      • Girona, Spain, 17007
        • Hospital de Girona Dr. Josep Trueta
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital Neurologische Klinik
  • United Kingdom
      • Leicester, United Kingdom
        • Regional Coordinating Centre United Kingdom
  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intensive BP lowering
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.
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.
Other Names:
  • Urapidil
  • Esmolol
  • Labetalol Hydrochloride
  • Metoprolol tartrate
  • Hydralazine Hydrochloride
  • Glycerol Trinitrate
  • Phentolamine mesylate
  • Nicardipine
  • Clonidine
  • Enalaprilat
  • Niroprusside
Other: Guideline recommended BP lowering
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.
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.
Other Names:
  • Urapidil
  • Esmolol
  • Labetalol Hydrochloride
  • Metoprolol tartrate
  • Hydralazine Hydrochloride
  • Glycerol Trinitrate
  • Phentolamine mesylate
  • Nicardipine
  • Clonidine
  • Enalaprilat
  • Niroprusside

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS)
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Death at 90 Days
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The George Institute

Collaborators

National Health and Medical Research Council, Australia

Investigators

  • Principal Investigator: Craig Anderson, PhD, The George Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

July 14, 2008

First Submitted That Met QC Criteria

July 14, 2008

First Posted (Estimate)

July 16, 2008

Study Record Updates

Last Update Posted (Estimate)

December 13, 2013

Last Update Submitted That Met QC Criteria

November 19, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NHMRC-571281

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Blood pressure management policies

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe