The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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An International Randomised Controlled Trial to Establish the Effects of Early Intensive Blood Pressure Lowering in Patients With Intracerebral Haemorrhage.

Conditions
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Intracerebral Hemorrhage, Stroke, Hypertension

Intervention / Treatment
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* Other: Blood pressure management policies


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intensive BP lowering<br>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. | Other: Blood pressure management policies<br>* 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.<br>* Other names: Niroprusside;|
| Other: Guideline recommended BP lowering<br>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. | Other: Blood pressure management policies<br>* 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.<br>* Other names: Niroprusside;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS) |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death at 90 Days |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral Hemorrhage, Stroke, antihypertensive drugs, blood pressure, disability, clinical trial, outcomes