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Completed

NCT Number: NCT00716079

The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial

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.

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Key information

Conditions

Intracerebral Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Hemorrhage Hypertension Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regional Coordinating Centre Argentina, Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood pressure management policies

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.

Other names: Labetalol Hydrochloride, Metoprolol tartrate, Hydralazine Hydrochloride, Glycerol Trinitrate, Phentolamine mesylate, Nicardipine, Urapidil, Esmolol, Clonidine, Enalaprilat, Niroprusside

Primary outcomes

  1. A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS)

    Time frame: 90 days

Secondary outcomes

  1. Death at 90 Days

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

The George Institute

Other

Collaborators

  • National Health and Medical Research Council, Australia

Registry information

Official study title

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

Acronym: INTERACT2

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jul 16, 2008
Registry last updated
Dec 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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