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The second intensive Blood Pressure reduction in acute cerebral haemorrhage trial.

An international randomised controlled trial to establish the effects of early intensive blood pressure lowering in patients with intracerebral haemorrhage

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12608000362392
Acronym
INTERACT 2
Enrollment
2800
Registered
2008-07-25
Start date
2008-10-13
Completion date
2012-08-30
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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 phentolo

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

The George Institute for International Health
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
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 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.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 27, 2026