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

Primary Purpose

Intracerebral Hemorrhage, Stroke, Hypertension

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Blood pressure management policies
Sponsored by
The George Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracerebral Hemorrhage focused on measuring Cerebral Hemorrhage, Stroke, antihypertensive drugs, blood pressure, disability, clinical trial, outcomes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic
  • Regional Coordinating Centre Argentina
  • Canberra Hospital
  • Concord Hospital
  • Gosford Hospital
  • John Hunter Hospital
  • Royal Prince Alfred Hospital
  • Royal Brisbane and Women's Hospital Health Service District
  • Western Hospital
  • Royal Melbourne Hospital
  • Austin Repatriation General Hospital
  • Box Hill Hospital
  • Monash Medical Centre
  • Sir Charles Gairdner Hospital
  • University of Graz
  • Medizinische Universitat Innsbruck
  • Allgemeines Krankenhaus Linz
  • AZ-VUB (University hospital Brussels)
  • CHU Tivoli
  • Regional Coordinating Centre Brazil
  • Regional Coordnating Centre Chile
  • Regional Coordinating Centre China: The George Institute China
  • Regional Coordinating and Monitoring Centre: Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai Institute of Hypertension, Shanghai Second Medical University
  • Helsinki University Central Hospital
  • Hôpital Jean Minjoz
  • Hopital de la Cavale-Blanche
  • Centre Hospitalier de Calais
  • CHU Bicetre
  • Hopital Roger Salengro
  • Centre Hospitalier de Meaux
  • CHU Nantes - Hopital Laennec
  • Hopital de Lariboisiere
  • Centre Hospitalier Sainte Anne
  • Regional Coordinating Centre Europe: Unite de recherche clinique Lariboisiere
  • Hôpital de la Salpêtrière
  • Groupe Hospitalier Paris Saint-Joseph
  • Hopital Tenon
  • Hopital Delafontaine
  • Centre Hospitalier de Versailles
  • Charite Campus Benjamin Franklin (CCBF)
  • Universitatsklinikum Dresden
  • Heinrich-Heine-Universitat
  • Universitat Erlangen-Nurnberg
  • Klinikum Frankfurt
  • Universitatsklinikum Frankfurt
  • Martin-Luther-Universität
  • Universitatsklinikum Hamburg-Eppendorf
  • Asklepios Klinik Barmbek
  • Asklepios Klinik Altona
  • University of Heidelberg
  • Universitatsklinikum Mannheim
  • Universitatsklinikum Ulm, Oberer Eselsberg
  • Prince of Wales Hospital
  • Regional Coordinating Centre India: The George Institute India
  • Ospedale di Citta di Castello
  • The Aga Khan University Hospital
  • Hospital de Sao Joao
  • Hospital General Universitario de Albacete
  • Hospital Clinic Barcelona
  • Hospital de Girona Dr. Josep Trueta
  • Inselspital Neurologische Klinik
  • Regional Coordinating Centre United Kingdom

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Intensive BP lowering

Guideline recommended BP lowering

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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 Measures

Death at 90 Days

Full Information

First Posted
July 14, 2008
Last Updated
November 19, 2013
Sponsor
The George Institute
Collaborators
National Health and Medical Research Council, Australia
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1. Study Identification

Unique Protocol Identification Number
NCT00716079
Brief Title
The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial
Acronym
INTERACT2
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

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The George Institute
Collaborators
National Health and Medical Research Council, Australia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Hemorrhage, Stroke, Hypertension
Keywords
Cerebral Hemorrhage, Stroke, antihypertensive drugs, blood pressure, disability, clinical trial, outcomes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2839 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intensive BP lowering
Arm Type
Other
Arm Description
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.
Arm Title
Guideline recommended BP lowering
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Blood pressure management policies
Other Intervention Name(s)
Labetalol Hydrochloride, Metoprolol tartrate, Hydralazine Hydrochloride, Glycerol Trinitrate, Phentolamine mesylate, Nicardipine, Urapidil, Esmolol, Clonidine, Enalaprilat, Niroprusside
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Death at 90 Days
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig Anderson, PhD
Organizational Affiliation
The George Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Regional Coordinating Centre Argentina
City
Buenos Aires
Country
Argentina
Facility Name
Canberra Hospital
City
Canberra
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Concord Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2138
Country
Australia
Facility Name
Gosford Hospital
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Facility Name
John Hunter Hospital
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2310
Country
Australia
Facility Name
Royal Prince Alfred Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital Health Service District
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Western Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Austin Repatriation General Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
Box Hill Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Monash Medical Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
University of Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Medizinische Universitat Innsbruck
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
Allgemeines Krankenhaus Linz
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
AZ-VUB (University hospital Brussels)
City
Jette
ZIP/Postal Code
1090
Country
Belgium
Facility Name
CHU Tivoli
City
La Louviere
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Regional Coordinating Centre Brazil
City
Sao Paulo
Country
Brazil
Facility Name
Regional Coordnating Centre Chile
City
Santiago
Country
Chile
Facility Name
Regional Coordinating Centre China: The George Institute China
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100088
Country
China
Facility Name
Regional Coordinating and Monitoring Centre: Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai Institute of Hypertension, Shanghai Second Medical University
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Hôpital Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Hopital de la Cavale-Blanche
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Centre Hospitalier de Calais
City
Calais
ZIP/Postal Code
62107
Country
France
Facility Name
CHU Bicetre
City
Kremlin-Bicetre
ZIP/Postal Code
94275
Country
France
Facility Name
Hopital Roger Salengro
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Centre Hospitalier de Meaux
City
Meaux
ZIP/Postal Code
77104
Country
France
Facility Name
CHU Nantes - Hopital Laennec
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital de Lariboisiere
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Centre Hospitalier Sainte Anne
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Regional Coordinating Centre Europe: Unite de recherche clinique Lariboisiere
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Hôpital de la Salpêtrière
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Groupe Hospitalier Paris Saint-Joseph
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Hopital Delafontaine
City
Saint-Denis
ZIP/Postal Code
27993
Country
France
Facility Name
Centre Hospitalier de Versailles
City
Versailles
ZIP/Postal Code
78157
Country
France
Facility Name
Charite Campus Benjamin Franklin (CCBF)
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Universitatsklinikum Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Heinrich-Heine-Universitat
City
Dusseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Universitat Erlangen-Nurnberg
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Klinikum Frankfurt
City
Frankfurt
ZIP/Postal Code
15236
Country
Germany
Facility Name
Universitatsklinikum Frankfurt
City
Frankfurt
ZIP/Postal Code
60528
Country
Germany
Facility Name
Martin-Luther-Universität
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Universitatsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Asklepios Klinik Barmbek
City
Hamburg
ZIP/Postal Code
22291
Country
Germany
Facility Name
Asklepios Klinik Altona
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Facility Name
University of Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitatsklinikum Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Universitatsklinikum Ulm, Oberer Eselsberg
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Prince of Wales Hospital
City
Sha Tin
Country
Hong Kong
Facility Name
Regional Coordinating Centre India: The George Institute India
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 033
Country
India
Facility Name
Ospedale di Citta di Castello
City
Citta di Castello
ZIP/Postal Code
6012
Country
Italy
Facility Name
The Aga Khan University Hospital
City
Karachi
Country
Pakistan
Facility Name
Hospital de Sao Joao
City
Porto
ZIP/Postal Code
4202-451
Country
Portugal
Facility Name
Hospital General Universitario de Albacete
City
Albacete
Country
Spain
Facility Name
Hospital Clinic Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de Girona Dr. Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Inselspital Neurologische Klinik
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Regional Coordinating Centre United Kingdom
City
Leicester
Country
United Kingdom

12. IPD Sharing Statement

Citations:
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18396107
Citation
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The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial

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