None listed
Conditions
Brief summary
INTERACT is an academic, international clinical trial to establish the possibility of undertaking a large scale study in 6,000 patients with acute intracerebral haemorrhage (bleeding into the brain) within 6 hours of onset and who also have associated high blood pressure. 400 patients will be recruited from Australia, New Zealand, China, Singapore and the United States of America. Patients will be assigned to either intensive blood pressure lowering treatment or current guideline based management of blood pressure alongside routine stroke management. Participants will be visited for 7 days during their hospital stay and then followed up at 1 month and 3 months intervals. The majority of information will be collected using standardised questionnaires and stroke scales. The study is a trial of blood pressure lowering policy using approved drugs within their labelling restrictions. The main purpose of the studyis to review the numbers of deaths and number of patients permanenetly disabled at 3 months.
Interventions
The trial has 2 phases a) Vanguard phase to establish the safety, potential efficiency and feasibility of conducting a large scale study; and b) Main phase to establish the effects of a management policy of early intensive blood pressure lowering on death & disability in patients with primary intracerebral haemorrhage compared to current guideline based management of high blood pressure in this setting.
Patients will be randomised to either intensive blood pressure lowering or current guidelin
The trial has 2 phases a) Vanguard phase to establish the safety, potential efficiency and feasibility of conducting a large scale study; and b) Main phase to establish the effects of a management policy of early intensive blood pressure lowering on death & disability in patients with primary intracerebral haemorrhage compared to current guideline based management of high blood pressure in this setting. Patients will be randomised to either intensive blood pressure lowering or current guideline based management. The drugs used are all licensed for this indication and are labetolol hydrochloride, metoprolol tartrate, hydralazine hydrochloride, glyceral trinitrate and phentoloamine. Intensive therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <140mmHg within 1 hour and to maintain this pressure during hospitalisation and for 3 months post hospitalisation. Oral or nasogastric treatment should be commenced within 24 hours. Control group therapy is given using oral or nasogastric tube and intravenous medication is only used if systolic blood pressure rises above 180mmHg. The target of control therapy is to manage blood pressure according to guidelines, which state blood pressure should be <180mmHg. The duration of intervention is 3 months for both groups.
Sponsors
The George Institute for International Health
Study design
Allocation
Randomised controlled trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with CT-confirmed spontaneous Intracerebral Haemorrhage (ICH) and elevated systolic BP (>150mmHg and <220mmHg), capacity to commence randomly assigned treatment with 6 hours of onset of ICH.
Exclusion criteria
Clear indication for or contraindication for intensive BP lowering. Evidence ICH secondary to a structural abnormality, or use of thrombolytic agent, an ischemic stroke within 30 days, a score of 3-5 on the Galsgow Coma Scale (indicating a deep coma), significant pre-stroke disability or medical illness and planned early neurosurgical intervention.
Outcome results
None listed