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

This study has been completed.
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Craig Anderson, The George Institute
ClinicalTrials.gov Identifier:
NCT00716079
First received: July 14, 2008
Last updated: November 19, 2013
Last verified: November 2013
Results First Received: August 21, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Intracerebral Hemorrhage
Stroke
Hypertension
Intervention: Other: Blood pressure management policies

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Intensive Blood-Pressure Lowering

Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour.

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.

Guideline-Recommended Blood-Pressure Lowering

Patients will receive management of BP that is based on a standard guideline, as published by the American Heart Association (AHA). 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.

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.


Participant Flow:   Overall Study
    Intensive Blood-Pressure Lowering   Guideline-Recommended Blood-Pressure Lowering
STARTED   1403   1436 
COMPLETED   1394   1421 
NOT COMPLETED   9   15 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Intensive Blood-Pressure Lowering

Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour.

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.

Guideline-Recommended Blood-Pressure Lowering

Patients will receive management of BP that is based on a standard guideline, as published by the American Heart Association (AHA). 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.

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.

Total Total of all reporting groups

Baseline Measures
   Intensive Blood-Pressure Lowering   Guideline-Recommended Blood-Pressure Lowering   Total 
Overall Participants Analyzed 
[Units: Participants]
 1403   1436   2839 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   797   770   1567 
>=65 years   606   666   1272 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.0  (13.1)   64.1  (12.6)   63.5  (12.9) 
Gender 
[Units: Participants]
     
Female   505   554   1059 
Male   898   882   1780 
Region of Enrollment 
[Units: Participants]
     
Argentina   2   2   4 
Australia   33   40   73 
Austria   35   28   63 
Belgium   6   6   12 
Brazil   8   9   17 
Chile   17   12   29 
China   950   976   1926 
Finland   19   17   36 
France   109   112   221 
Germany   70   71   141 
Hong Kong   0   1   1 
India   48   49   97 
Italy   19   28   47 
Netherlands   1   1   2 
Norway   2   3   5 
Pakistan   5   4   9 
Portugal   12   10   22 
Spain   25   25   50 
Switzerland   2   1   3 
United Kingdom   35   35   70 
United States   5   6   11 


  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   Death at 90 Days   [ Time Frame: 90 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Professor Craig Anderson
Organization: The George Institute for Global Health
phone: +612 9993 4521
e-mail: canderson@georgeinstitute.org.au


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Craig Anderson, The George Institute
ClinicalTrials.gov Identifier: NCT00716079     History of Changes
Other Study ID Numbers: NHMRC-571281
Study First Received: July 14, 2008
Results First Received: August 21, 2013
Last Updated: November 19, 2013
Health Authority: Australia: National Health and Medical Research Council