The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT2)
Intracerebral Hemorrhage, Stroke, Hypertension
About this trial
This is an interventional treatment trial for Intracerebral Hemorrhage focused on measuring Cerebral Hemorrhage, Stroke, antihypertensive drugs, blood pressure, disability, clinical trial, outcomes
Eligibility 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.
Sites / Locations
- Mayo Clinic
- Regional Coordinating Centre Argentina
- Canberra Hospital
- Concord Hospital
- Gosford Hospital
- John Hunter Hospital
- Royal Prince Alfred Hospital
- Royal Brisbane and Women's Hospital Health Service District
- Western Hospital
- Royal Melbourne Hospital
- Austin Repatriation General Hospital
- Box Hill Hospital
- Monash Medical Centre
- Sir Charles Gairdner Hospital
- University of Graz
- Medizinische Universitat Innsbruck
- Allgemeines Krankenhaus Linz
- AZ-VUB (University hospital Brussels)
- CHU Tivoli
- Regional Coordinating Centre Brazil
- Regional Coordnating Centre Chile
- Regional Coordinating Centre China: The George Institute China
- Regional Coordinating and Monitoring Centre: Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai Institute of Hypertension, Shanghai Second Medical University
- Helsinki University Central Hospital
- Hôpital Jean Minjoz
- Hopital de la Cavale-Blanche
- Centre Hospitalier de Calais
- CHU Bicetre
- Hopital Roger Salengro
- Centre Hospitalier de Meaux
- CHU Nantes - Hopital Laennec
- Hopital de Lariboisiere
- Centre Hospitalier Sainte Anne
- Regional Coordinating Centre Europe: Unite de recherche clinique Lariboisiere
- Hôpital de la Salpêtrière
- Groupe Hospitalier Paris Saint-Joseph
- Hopital Tenon
- Hopital Delafontaine
- Centre Hospitalier de Versailles
- Charite Campus Benjamin Franklin (CCBF)
- Universitatsklinikum Dresden
- Heinrich-Heine-Universitat
- Universitat Erlangen-Nurnberg
- Klinikum Frankfurt
- Universitatsklinikum Frankfurt
- Martin-Luther-Universität
- Universitatsklinikum Hamburg-Eppendorf
- Asklepios Klinik Barmbek
- Asklepios Klinik Altona
- University of Heidelberg
- Universitatsklinikum Mannheim
- Universitatsklinikum Ulm, Oberer Eselsberg
- Prince of Wales Hospital
- Regional Coordinating Centre India: The George Institute India
- Ospedale di Citta di Castello
- The Aga Khan University Hospital
- Hospital de Sao Joao
- Hospital General Universitario de Albacete
- Hospital Clinic Barcelona
- Hospital de Girona Dr. Josep Trueta
- Inselspital Neurologische Klinik
- Regional Coordinating Centre United Kingdom
Arms of the Study
Arm 1
Arm 2
Other
Other
Intensive BP lowering
Guideline recommended 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.
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.