The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT2)
This study is ongoing, but not recruiting participants.
Sponsor:
The George Institute
Collaborator:
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Craig Anderson, The George Institute
ClinicalTrials.gov Identifier:
NCT00716079
First received: July 14, 2008
Last updated: September 3, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Intracerebral Hemorrhage Stroke Hypertension |
Other: Blood pressure management policies |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
COL4A1-related brain small-vessel disease
MedlinePlus related topics:
High Blood Pressure
Drug Information available for:
Phentolamine
Phentolamine mesylate
Hydralazine
Hydralazine hydrochloride
Clonidine
Labetalol hydrochloride
Labetalol
Metoprolol
Nicardipine hydrochloride
Nicardipine
Metoprolol tartrate
Enalapril
Enalapril maleate
Enalaprilat
Metoprolol succinate
Metoprolol fumarate
U.S. FDA Resources
Further study details as provided by The George Institute:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- death and dependency in patients treated <4 hours; death; dependency; HRQoL; physical function; recurrent vascular events; days of hospitalisation; permanent residential care [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 2800 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Intensive
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.
|
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:
|
|
Conservative
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.
|
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:
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00716079
Show 62 Study Locations
Show 62 Study LocationsSponsors and Collaborators
The George Institute
National Health and Medical Research Council, Australia
Investigators
| Principal Investigator: | Craig Anderson, PhD | The George Institute |
More Information
Additional Information:
Publications:
Additional 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 History of Changes |
| Other Study ID Numbers: | NHMRC-571281 |
| Study First Received: | July 14, 2008 |
| Last Updated: | September 3, 2012 |
| Health Authority: | Australia: National Health and Medical Research Council |
Keywords provided by The George Institute:
|
Cerebral Hemorrhage Stroke antihypertensive drugs blood pressure |
disability clinical trial outcomes |
Additional relevant MeSH terms:
|
Hemorrhage Hypertension Stroke Cerebral Hemorrhage Pathologic Processes Vascular Diseases Cardiovascular Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Intracranial Hemorrhages Antihypertensive Agents Metoprolol Labetalol |
Enalaprilat Hydralazine Nicardipine Phentolamine Metoprolol succinate Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Anti-Arrhythmia Agents Sympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists |
ClinicalTrials.gov processed this record on May 19, 2013