None listed
Conditions
Brief summary
The main phase of an academic lead and conducted, international, multi-centre, open label, blinded endpoint, randomised controlled trial to establish the balance of benefits and risks of a treatment strategy of early intensive lowering of blood pressure (BP) compared to a conservative BP lowering policy in patients with acute primary intracerebral haemorrhage (ICH) and co-existing elevated BP without any definite indication or contraindication to treatment.
Interventions
Patients will be randomised to either intensive blood pressure lowering or current guideline based management. As the trial is an assessment of Blood pressure (BP) management policies, there is some flexibility in the use of particular BP lowering agents to achieve BP targets. Intravenous treatment protocols, based on available medications, are provided. Only licensed drugs are used such as 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 will include less intensive management of BP using similar choice of route and agents 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. Follow up is 3 months for both groups.
Sponsors
Study design
Eligibility
Inclusion criteria
Patients with computerised tomography (CT)-confirmed spontaneous Intracerebral Haemorrhage (ICH) and elevated systolic blood pressure (>150mmHg and <220mmHg), capacity to commence randomly assigned treatment within 6 hours of onset of ICH.
Exclusion criteria
Clear indication or contraindication to intensive BP lowering. Evidence ICH secondary to a structural abnormality, or use of thrombolytic agent, an ischaemic stroke within 30 days, a score of 3-5 on the Glasgow Coma Scale (indicating deep coma), significant pre-stroke disability or medical illness, planned early neurological intervention and participation in another clinical trial.