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

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ClinicalTrials.gov Identifier: NCT00716079
Recruitment Status : Completed
First Posted : July 16, 2008
Results First Posted : October 28, 2013
Last Update Posted : December 13, 2013
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Craig Anderson, The George Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Intracerebral Hemorrhage
Stroke
Hypertension
Intervention Other: Blood pressure management policies
Enrollment 2839
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intensive Blood-Pressure Lowering Guideline-Recommended Blood-Pressure Lowering
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 1403 1436
Completed 1394 1421
Not Completed 9 15
Arm/Group Title Intensive Blood-Pressure Lowering Guideline-Recommended Blood-Pressure Lowering Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 1403 1436 2839
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1403 participants 1436 participants 2839 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
797
  56.8%
770
  53.6%
1567
  55.2%
>=65 years
606
  43.2%
666
  46.4%
1272
  44.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1403 participants 1436 participants 2839 participants
63.0  (13.1) 64.1  (12.6) 63.5  (12.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1403 participants 1436 participants 2839 participants
Female
505
  36.0%
554
  38.6%
1059
  37.3%
Male
898
  64.0%
882
  61.4%
1780
  62.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1403 participants 1436 participants 2839 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
1.Primary Outcome
Title A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS)
Hide Description [Not Specified]
Time Frame 90 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
In the intensive group 12 patients were alive at 90 days but missing data on mRS (required for primary outcome), and 9 patients in the guideline group
Arm/Group Title Intensive Blood-Pressure Lowering Guideline-Recommended Blood-Pressure Lowering
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 1382 1412
Measure Type: Number
Unit of Measure: participants
719 785
2.Secondary Outcome
Title Death at 90 Days
Hide Description [Not Specified]
Time Frame 90 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intensive Blood-Pressure Lowering Guideline-Recommended Blood-Pressure Lowering
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 1394 1421
Measure Type: Number
Unit of Measure: participants
166 170
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events were not collected, only Serious Adverse Events.
 
Arm/Group Title Intensive Blood-Pressure Lowering Guideline-Recommended Blood-Pressure Lowering
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Intensive Blood-Pressure Lowering Guideline-Recommended Blood-Pressure Lowering
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intensive Blood-Pressure Lowering Guideline-Recommended Blood-Pressure Lowering
Affected / at Risk (%) Affected / at Risk (%)
Total   324/1399 (23.16%)   329/1430 (23.01%) 
Cardiac disorders     
Acute MI/coronary event/other *  5/1399 (0.36%)  6/1430 (0.42%) 
Other cardiac disease *  24/1399 (1.72%)  27/1430 (1.89%) 
General disorders     
Direct effects of primary ICH event *  143/1399 (10.22%)  154/1430 (10.77%) 
Non-vasular medical *  52/1399 (3.72%)  50/1430 (3.50%) 
Infections and infestations     
Respiratory infections *  66/1399 (4.72%)  77/1430 (5.38%) 
Sepsis (includes other infections) *  26/1399 (1.86%)  24/1430 (1.68%) 
Injury, poisoning and procedural complications     
Non-vasular injury (including fracture) *  107/1399 (7.65%)  96/1430 (6.71%) 
Renal and urinary disorders     
Renal failure *  6/1399 (0.43%)  11/1430 (0.77%) 
Vascular disorders     
ICH *  5/1399 (0.36%)  7/1430 (0.49%) 
Ischaemic/undifferentiated stroke *  9/1399 (0.64%)  8/1430 (0.56%) 
Other vascular disease *  15/1399 (1.07%)  16/1430 (1.12%) 
Severe hypotension *  8/1399 (0.57%)  12/1430 (0.84%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intensive Blood-Pressure Lowering Guideline-Recommended Blood-Pressure Lowering
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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
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
First Submitted: July 14, 2008
First Posted: July 16, 2008
Results First Submitted: August 21, 2013
Results First Posted: October 28, 2013
Last Update Posted: December 13, 2013