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NCT00716079

The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial

Last Updated: 2013-12-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

Total Enrollment

2839 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-12-31

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.

Conditions

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Intracerebral Hemorrhage Stroke Hypertension

Keywords

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Cerebral Hemorrhage Stroke antihypertensive drugs blood pressure disability clinical trial outcomes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intensive BP lowering

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.

Group Type OTHER

Blood pressure management policies

Intervention Type OTHER

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 BP lowering

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.

Group Type OTHER

Blood pressure management policies

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Labetalol Hydrochloride Metoprolol tartrate Hydralazine Hydrochloride Glycerol Trinitrate Phentolamine mesylate Nicardipine Urapidil Esmolol Clonidine Enalaprilat Niroprusside

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Craig Anderson

Senior Director, Neurological and Mental Health Division

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Craig Anderson, PhD

Role: PRINCIPAL_INVESTIGATOR

The George Institute

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Regional Coordinating Centre Argentina

Buenos Aires, , Argentina

Site Status

Canberra Hospital

Canberra, Australian Capital Territory, Australia

Site Status

Concord Hospital

Concord, New South Wales, Australia

Site Status

Gosford Hospital

Gosford, New South Wales, Australia

Site Status

John Hunter Hospital

Newcastle, New South Wales, Australia

Site Status

Royal Prince Alfred Hospital

Sydney, New South Wales, Australia

Site Status