An International Randomised Controlled Trial to Establish the Effects of Early Intensive Blood Pressure Lowering in Patients With Intracerebral Haemorrhage.
| Registry | NCT00716079, acronym INTERACT2 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 2839 (Actual) |
| Sponsor | The George Institute (Other); collaborators: National Health and Medical Research Council, Australia |
| Conditions | Intracerebral Hemorrhage, Stroke, Hypertension |
| Interventions | Blood pressure management policies (Other) |
| Dates | start 2008-09-01, primary completion 2012-12-01, completion 2012-12-01, first posted 2008-07-16, last updated 2013-12-13 |
| Locations | 62 sites in United States, Argentina, Australia, Austria, Belgium, Brazil, Chile, China and 11 more countries |
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All trials for Intracerebral Hemorrhage All trials for Stroke All trials of Blood pressure management policies
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Intensive BP lowering | Other | Other: Blood pressure management policies | 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. |
| Guideline recommended BP lowering | Other | Other: Blood pressure management policies | 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. |
Sex: All, ages: 18 Years to any
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.
| Milestone | Intensive Blood-Pressure Lowering | Guideline-Recommended Blood-Pressure Lowering |
|---|---|---|
| Started | 1403 | 1436 |
| Completed | 1394 | 1421 |
| Not completed | 9 | 15 |
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Intensive Blood-Pressure Lowering | 0 | 324/1399 (23.2%) | 0 |
| Guideline-Recommended Blood-Pressure Lowering | 0 | 329/1430 (23.0%) | 0 |
| Term | Organ system | Intensive Blood-Pressure Lowering | Guideline-Recommended Blood-Pressure Lowering |
|---|---|---|---|
| Direct effects of primary ICH event | General disorders | 143/1399 | 154/1430 |
| ICH | Vascular disorders | 5/1399 | 7/1430 |
| Ischaemic/undifferentiated stroke | Vascular disorders | 9/1399 | 8/1430 |
| Acute MI/coronary event/other | Cardiac disorders | 5/1399 | 6/1430 |
| Other vascular disease | Vascular disorders | 15/1399 | 16/1430 |
| Other cardiac disease | Cardiac disorders | 24/1399 | 27/1430 |
| Renal failure | Renal and urinary disorders | 6/1399 | 11/1430 |
| Severe hypotension | Vascular disorders | 8/1399 | 12/1430 |
| Respiratory infections | Infections and infestations | 66/1399 | 77/1430 |
| Sepsis (includes other infections) | Infections and infestations | 26/1399 | 24/1430 |
| Non-vasular medical | General disorders | 52/1399 | 50/1430 |
| Non-vasular injury (including fracture) | Injury, poisoning and procedural complications | 107/1399 | 96/1430 |
| Facility | City | Country | Status |
|---|---|---|---|
| Mayo Clinic | Rochester, Minnesota | United States | |
| Regional Coordinating Centre Argentina | Buenos Aires | Argentina | |
| Canberra Hospital | Canberra, Australian Capital Territory | Australia | |
| Concord Hospital | Concord, New South Wales | Australia | |
| Gosford Hospital | Gosford, New South Wales | Australia | |
| John Hunter Hospital | Newcastle, New South Wales | Australia | |
| Royal Prince Alfred Hospital | Sydney, New South Wales | Australia | |
| Royal Brisbane and Women's Hospital Health Service District | Brisbane, Queensland | Australia | |
| Western Hospital | Melbourne, Victoria | Australia | |
| Royal Melbourne Hospital | Melbourne, Victoria | Australia | |
| Austin Repatriation General Hospital | Melbourne, Victoria | Australia | |
| Box Hill Hospital | Melbourne, Victoria | Australia | |
| Monash Medical Centre | Melbourne, Victoria | Australia | |
| Sir Charles Gairdner Hospital | Perth, Western Australia | Australia | |
| University of Graz | Graz | Austria | |
| Medizinische Universitat Innsbruck | Innsbruck | Austria | |
| Allgemeines Krankenhaus Linz | Linz | Austria | |
| AZ-VUB (University hospital Brussels) | Jette | Belgium | |
| CHU Tivoli | La Louvière | Belgium | |
| Regional Coordinating Centre Brazil | São Paulo | Brazil | |
| Regional Coordnating Centre Chile | Santiago | Chile | |
| Regional Coordinating Centre China: The George Institute China | Beijing, Beijing Municipality | China | |
| Regional Coordinating and Monitoring Centre: Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai Institute of Hypertension, Shanghai Second Medical University | Shanghai | China | |
| Helsinki University Central Hospital | Helsinki | Finland | |
| Hôpital Jean Minjoz | Besançon | France | |
| Hopital de la Cavale-Blanche | Brest | France | |
| Centre Hospitalier de Calais | Calais | France | |
| CHU Bicetre | Le Kremlin-Bicêtre | France | |
| Hopital Roger Salengro | Lille | France | |
| Centre Hospitalier de Meaux | Meaux | France | |
| CHU Nantes - Hopital Laennec | Nantes | France | |
| Hopital de Lariboisiere | Paris | France | |
| Centre Hospitalier Sainte Anne | Paris | France | |
| Regional Coordinating Centre Europe: Unite de recherche clinique Lariboisiere | Paris | France | |
| Hôpital de la Salpêtrière | Paris | France | |
| Groupe Hospitalier Paris Saint-Joseph | Paris | France | |
| Hopital Tenon | Paris | France | |
| Hopital Delafontaine | Saint-Denis | France | |
| Centre Hospitalier de Versailles | Versailles | France | |
| Charite Campus Benjamin Franklin (CCBF) | Berlin | Germany | |
| Universitatsklinikum Dresden | Dresden | Germany | |
| Heinrich-Heine-Universitat | Düsseldorf | Germany | |
| Universitat Erlangen-Nurnberg | Erlangen | Germany | |
| Klinikum Frankfurt | Frankfurt | Germany | |
| Universitatsklinikum Frankfurt | Frankfurt | Germany | |
| Martin-Luther-Universität | Halle | Germany | |
| Universitatsklinikum Hamburg-Eppendorf | Hamburg | Germany | |
| Asklepios Klinik Barmbek | Hamburg | Germany | |
| Asklepios Klinik Altona | Hamburg | Germany | |
| University of Heidelberg | Heidelberg | Germany | |
| Universitatsklinikum Mannheim | Mannheim | Germany | |
| Universitatsklinikum Ulm, Oberer Eselsberg | Ulm | Germany | |
| Prince of Wales Hospital | Shatin | Hong Kong | |
| Regional Coordinating Centre India: The George Institute India | Hyderabad, Andhra Pradesh | India | |
| Ospedale di Citta di Castello | Città di Castello | Italy | |
| The Aga Khan University Hospital | Karachi | Pakistan | |
| Hospital de Sao Joao | Porto | Portugal | |
| Hospital General Universitario de Albacete | Albacete | Spain | |
| Hospital Clinic Barcelona | Barcelona | Spain | |
| Hospital de Girona Dr. Josep Trueta | Girona | Spain | |
| Inselspital Neurologische Klinik | Bern | Switzerland | |
| Regional Coordinating Centre United Kingdom | Leicester | United Kingdom |