Trial Outcomes & Findings for The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (NCT NCT00716079)

NCT ID: NCT00716079

Last Updated: 2013-12-13

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 2839 participants
• Primary outcome timeframe: 90 days
• Results posted on: 2013-12-13

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	1403	1436
Overall Study COMPLETED	1394	1421
Overall Study NOT COMPLETED	9	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial

Baseline characteristics by cohort

Measure	Intensive Blood-Pressure Lowering n=1403 Participants 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 n=1436 Participants 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 n=2839 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	797 Participants n=5 Participants	770 Participants n=7 Participants	1567 Participants n=5 Participants
Age, Categorical >=65 years	606 Participants n=5 Participants	666 Participants n=7 Participants	1272 Participants n=5 Participants
Age, Continuous	63.0 years STANDARD_DEVIATION 13.1 • n=5 Participants	64.1 years STANDARD_DEVIATION 12.6 • n=7 Participants	63.5 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	505 Participants n=5 Participants	554 Participants n=7 Participants	1059 Participants n=5 Participants
Sex: Female, Male Male	898 Participants n=5 Participants	882 Participants n=7 Participants	1780 Participants n=5 Participants
Region of Enrollment Argentina	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Australia	33 participants n=5 Participants	40 participants n=7 Participants	73 participants n=5 Participants
Region of Enrollment Austria	35 participants n=5 Participants	28 participants n=7 Participants	63 participants n=5 Participants
Region of Enrollment Belgium	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants
Region of Enrollment Brazil	8 participants n=5 Participants	9 participants n=7 Participants	17 participants n=5 Participants
Region of Enrollment Chile	17 participants n=5 Participants	12 participants n=7 Participants	29 participants n=5 Participants
Region of Enrollment China	950 participants n=5 Participants	976 participants n=7 Participants	1926 participants n=5 Participants
Region of Enrollment Finland	19 participants n=5 Participants	17 participants n=7 Participants	36 participants n=5 Participants
Region of Enrollment France	109 participants n=5 Participants	112 participants n=7 Participants	221 participants n=5 Participants
Region of Enrollment Germany	70 participants n=5 Participants	71 participants n=7 Participants	141 participants n=5 Participants
Region of Enrollment Hong Kong	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment India	48 participants n=5 Participants	49 participants n=7 Participants	97 participants n=5 Participants
Region of Enrollment Italy	19 participants n=5 Participants	28 participants n=7 Participants	47 participants n=5 Participants
Region of Enrollment Netherlands	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Norway	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment Pakistan	5 participants n=5 Participants	4 participants n=7 Participants	9 participants n=5 Participants
Region of Enrollment Portugal	12 participants n=5 Participants	10 participants n=7 Participants	22 participants n=5 Participants
Region of Enrollment Spain	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants
Region of Enrollment Switzerland	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment United Kingdom	35 participants n=5 Participants	35 participants n=7 Participants	70 participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	6 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days

Population: 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

Outcome measures

Measure	Intensive Blood-Pressure Lowering n=1382 Participants 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 n=1412 Participants 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.
A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS)	719 participants	785 participants

SECONDARY outcome

Timeframe: 90 days

Outcome measures

Measure	Intensive Blood-Pressure Lowering n=1394 Participants 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 n=1421 Participants 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.
Death at 90 Days	166 participants	170 participants

Adverse Events

Intensive Blood-Pressure Lowering

Serious events: 324 serious events

Other events: 0 other events

Deaths: 0 deaths

Guideline-Recommended Blood-Pressure Lowering

Serious events: 329 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intensive Blood-Pressure Lowering n=1399 participants at risk 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 n=1430 participants at risk 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.
General disorders Direct effects of primary ICH event	10.2% 143/1399 Adverse events were not collected, only Serious Adverse Events.	10.8% 154/1430 Adverse events were not collected, only Serious Adverse Events.
Vascular disorders ICH	0.36% 5/1399 Adverse events were not collected, only Serious Adverse Events.	0.49% 7/1430 Adverse events were not collected, only Serious Adverse Events.
Vascular disorders Ischaemic/undifferentiated stroke	0.64% 9/1399 Adverse events were not collected, only Serious Adverse Events.	0.56% 8/1430 Adverse events were not collected, only Serious Adverse Events.
Cardiac disorders Acute MI/coronary event/other	0.36% 5/1399 Adverse events were not collected, only Serious Adverse Events.	0.42% 6/1430 Adverse events were not collected, only Serious Adverse Events.
Vascular disorders Other vascular disease	1.1% 15/1399 Adverse events were not collected, only Serious Adverse Events.	1.1% 16/1430 Adverse events were not collected, only Serious Adverse Events.
Cardiac disorders Other cardiac disease	1.7% 24/1399 Adverse events were not collected, only Serious Adverse Events.	1.9% 27/1430 Adverse events were not collected, only Serious Adverse Events.
Renal and urinary disorders Renal failure	0.43% 6/1399 Adverse events were not collected, only Serious Adverse Events.	0.77% 11/1430 Adverse events were not collected, only Serious Adverse Events.
Vascular disorders Severe hypotension	0.57% 8/1399 Adverse events were not collected, only Serious Adverse Events.	0.84% 12/1430 Adverse events were not collected, only Serious Adverse Events.
Infections and infestations Respiratory infections	4.7% 66/1399 Adverse events were not collected, only Serious Adverse Events.	5.4% 77/1430 Adverse events were not collected, only Serious Adverse Events.
Infections and infestations Sepsis (includes other infections)	1.9% 26/1399 Adverse events were not collected, only Serious Adverse Events.	1.7% 24/1430 Adverse events were not collected, only Serious Adverse Events.
General disorders Non-vasular medical	3.7% 52/1399 Adverse events were not collected, only Serious Adverse Events.	3.5% 50/1430 Adverse events were not collected, only Serious Adverse Events.
Injury, poisoning and procedural complications Non-vasular injury (including fracture)	7.6% 107/1399 Adverse events were not collected, only Serious Adverse Events.	6.7% 96/1430 Adverse events were not collected, only Serious Adverse Events.

Other adverse events

Adverse event data not reported

Additional Information

Professor Craig Anderson

The George Institute for Global Health

Phone: +612 9993 4521

Email: canderson@georgeinstitute.org.au

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place