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
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Study Type | Interventional |
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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 |
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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 | |
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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 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 1403 participants | 1436 participants | 2839 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
797 56.8%
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770 53.6%
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1567 55.2%
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>=65 years |
606 43.2%
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666 46.4%
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1272 44.8%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 1403 participants | 1436 participants | 2839 participants | |
Female |
505 36.0%
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554 38.6%
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1059 37.3%
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Male |
898 64.0%
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882 61.4%
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1780 62.7%
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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 |
Name/Title: | Professor Craig Anderson |
Organization: | The George Institute for Global Health |
Phone: | +612 9993 4521 |
EMail: | canderson@georgeinstitute.org.au |
Responsible Party: | Craig Anderson, The George Institute |
ClinicalTrials.gov Identifier: | NCT00716079 |
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 |