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02 September 2010
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| [ Print-friendly version ] |
| The second intensive blood pressure reduction in acute cerebral haemorrhage trial |
| ISRCTN | ISRCTN73916115 |
| ClinicalTrials.gov identifier | |
| Public title | The second intensive blood pressure reduction in acute cerebral haemorrhage trial |
| Scientific title | An international randomised controlled trial to establish the effects of early intensive blood pressure lowering in patients with intracerebral haemorrhage |
| Acronym | INTERACT2 |
| Serial number at source | NHMRC-571281 |
| Study hypothesis | 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. |
| Ethics approval | Ethics approval received from the SSWAHS Ethics Review Committee (RPAH Zone) on the 26th June 2008 (ref: 08/RPAH/273). |
| Study design | Multicentre, treatment, parallel assignment, two armed, open label, randomised, active controlled, safety/efficacy study |
| Countries of recruitment | Australia, Austria, Belgium, China, France, Germany, Netherlands, New Zealand, Spain, Switzerland, United Kingdom |
| Disease/condition/study domain | Intracerebral haemorrhage |
| Participants - inclusion criteria |
1. Patients with computed tomography (CT)-confirmed spontaneous intracerebral haemorrhage (ICH)
2. Elevated systolic blood pressure (greater than 150 mmHg and less than 220 mmHg) 3. Capacity to commence randomly assigned treatment within 6 hours of onset of ICH 4. Able to be 'actively' treated and admitted to a monitored facility 5. Male and female, aged older than 18 years old |
| Participants - exclusion criteria |
1. Clear indication or contraindication to intensive BP lowering
2. Evidence ICH secondary to a structural abnormality 3. Use of thrombolytic agent 4. Previous ischaemic stroke within 30 days 5. A very high likelihood that the patient will die within the next 24 hours on the basis of clinical and/or radiological criteria 6. Score of 3 - 5 on the Glasgow Coma Scale (indicating deep coma) 7. Significant pre-stroke disability or advanced dementia 8. Planned early neurological intervention 9. Participation in another clinical trial 10. A high likelihood that the patient will not adhere to the study treatment and follow-up regimen |
| Anticipated start date | 01/09/2008 |
| Anticipated end date | 01/09/2011 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please contact cdelcourt@george.org.au or canderson@george.org.au to request a patient information sheet |
| Target number of participants | 2800 |
| Interventions |
Intensive arm:
Intensive blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP less than 140 mmHg within 1 hour. Conservative arm: 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. Intervention: 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. Drugs: Labetalol Hydrochloride Metoprolol tartrate Hydralazine Hydrochloride Glycerol Trinitrate Phentolamine mesylate Nicardipine Urapidil Esmolol Clonidine Enalaprilat Nitroprusside |
| Primary outcome measure(s) | A composite of death or dependency, with dependency being defined by a score of 3 to 5 on the Modified Rankin Scale (mRS). Timeframe: 90 days. |
| Secondary outcome measure(s) |
1. Death and dependency in patients treated less than 4 hours
2. Death 3. Dependency 4. Health Related Quality of Life (HRQoL) 5. Physical function 6. Recurrent vascular events 7. Days of hospitalisation 8. Permanent residential care Timeframe: 90 days |
| Sources of funding | National Health and Medical Research Council (NHMRC) (Australia) |
| Trial website | http://www.thegeorgeinstitute.org/ |
| Publications |
1. 2008 pilot study results in http://www.ncbi.nlm.nih.gov/pubmed/18396107
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20446945 |
| Contact name | Prof Craig Anderson |
| Address |
The George Institute Royal Prince Alfred Hospital
Level 10 King George V Building Missenden Road Camperdown |
| City/town | Sydney |
| Zip/Postcode | 2050 |
| Country | Australia |
| Sponsor | National Health and Medical Research Council (NHMRC) (Australia) |
| Address |
GPO Box 1421
ACT 2601 |
| City/town | Canberra |
| Zip/Postcode | 2601 |
| Country | Australia |
| Tel | 1800 500 983 |
| Fax | +61 (0)2 6217 9165 |
| grantnet.help@nhmrc.gov.au | |
| Sponsor website: | http://www.nhmrc.gov.au/ |
| Date applied | 10/07/2008 |
| Last edited | 11/05/2010 |
| Date ISRCTN assigned | 18/07/2008 |
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| © 2010 ISRCTN unless otherwise stated. | |
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