The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT2)
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| ClinicalTrials.gov Identifier: NCT00716079 |
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Recruitment Status :
Completed
First Posted : July 16, 2008
Results First Posted : October 28, 2013
Last Update Posted : December 13, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Intracerebral Hemorrhage Stroke Hypertension | Other: Blood pressure management policies | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 2839 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An International Randomised Controlled Trial to Establish the Effects of Early Intensive Blood Pressure Lowering in Patients With Intracerebral Haemorrhage. |
| Study Start Date : | September 2008 |
| Actual Primary Completion Date : | December 2012 |
| Actual Study Completion Date : | December 2012 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Other: 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.
Other Names:
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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.
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Other: 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.
Other Names:
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- 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 ]
- Death at 90 Days [ Time Frame: 90 days ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00716079
Show 62 study locations
| Principal Investigator: | Craig Anderson, PhD | The George Institute |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Craig Anderson, Senior Director, Neurological and Mental Health Division, The George Institute |
| ClinicalTrials.gov Identifier: | NCT00716079 |
| Other Study ID Numbers: |
NHMRC-571281 |
| First Posted: | July 16, 2008 Key Record Dates |
| Results First Posted: | October 28, 2013 |
| Last Update Posted: | December 13, 2013 |
| Last Verified: | November 2013 |
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Cerebral Hemorrhage Stroke antihypertensive drugs blood pressure |
disability clinical trial outcomes |
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Cerebral Hemorrhage Hemorrhage Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Intracranial Hemorrhages Metoprolol Clonidine Hydralazine Labetalol Nicardipine |
Phentolamine Urapidil Enalaprilat Esmolol Glycerol Anti-Arrhythmia Agents Antihypertensive Agents Sympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents |