Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage

Intracranial Hemorrhages Clinical Trial

Official title:

A Randomised Trial to Establish the Effects of Early Intensive Blood Pressure Lowering on Death and Disability in Patients With Stroke Due to Acute Intracerebral Haemorrhage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00226096
• Other study ID #: NDA1INTERACT
• Status: Completed
• Phase: N/A
• First received: September 23, 2005
• Last updated: June 25, 2008
• Start date: November 2005
• Est. completion date: September 2007

Study information

• Verified date: June 2008
• Source: The George Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationNew Zealand: Health Research Council
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine whether lowering high blood pressure levels after the start of a stroke caused by bleeding in the brain (intracerebral haemorrhage) will reduce the chances of a person dying or surviving with a long term disability. The study will be undertaken in two phases: a vanguard phase in 400 patients, to plan for a main phase in 2000 patients.

Description:

Intracerebral haemorrhage (ICH) is one of the most serious subtypes of stroke, affecting approximately 2-3 million people worldwide each year. About one third of people with ICH die early after onset and the majority of survivors are left with major long-term disability. Administration of activated recombinant human Factor VII has been shown to limit haematoma expansion in randomised controlled clinical trials; however, future clinical use of this agent may be limited by a short therapeutic time window, contraindication in patients at risk of thromboembolism and high cost. Currently, no acute medical therapies have been shown to alter outcome in ICH and the role of surgery remains uncertain.

Blood pressure (BP) levels are strongly and positively associated with the incidence of first and recurrent stroke and there is definite evidence that BP lowering reduces stroke risk. Although BP levels are commonly elevated after stroke onset, particularly in ICH, the effects of BP lowering treatment in the acute phase of stroke remain unknown.

The study aims to establish the effectiveness of a management policy of early intensive BP lowering on death & disability in patients with primary ICH compared to current guideline-based management of high BP in the clinical setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 404
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 years or above

• Acute stroke due to spontaneous ICH confirmed by clinical history & CT scan

• At least 2 systolic BP measurements of >/=150mmHg and </=220mmHg, recorded 2 or more minutes apart

• Able to commence randomly assigned BP lowering regimen within 6 hours of stroke onset

• Able to be actively treated and admitted to a monitored facility e.g. HDU/ICU/acute stroke unit

Exclusion Criteria:

• Known definite contraindication to an intensive BP lowering regimen

• Known definite indication for intensive BP lowering regimen as (or more) intensive than the active treatment arm

• Definite evidence that the ICH is secondary to a structural abnormality in the brain

• 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

• Known advanced dementia or significant pre-stroke disability

• Concomitant medical illness that would interfere with outcome assessments and follow up

• Already booked for surgical evacuation of haematoma

• Previous participation in this trial or current participation in another investigational drug trial

• A high likelihood that the patient will not adhere to the study treatment and follow up regimen

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• CVA (Cerebrovascular Accident)
• Hemorrhage
• Intracranial Hemorrhages
• Stroke

Intervention

Drug:
• Labetalol Hydrochloride

• Metoprolol tartrate

• Hydralazine Hydrochloride

• Glycerol Trinitrate

• Phentolamine mesylate

• Nicardipine

• Urapidil

• Esmolol

• Clonidine

• Enalaprilat

• Nitroprusside

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Concord Hospital	Concord	New South Wales
Australia	Gosford Hospital	Gosford	New South Wales
Australia	St George Hospital	Kogarah	New South Wales
Australia	Alfred Hospital	Melbourne	Victoria
Australia	Austin Health	Melbourne	Victoria
Australia	Box Hill Hospital	Melbourne	Victoria
Australia	Monash Medical Centre	Melbourne	Victoria
Australia	Royal Melbourne Hospital	Melbourne	Victoria
Australia	St Vincent's Hospital	Melbourne	Victoria
Australia	John Hunter Hospital	Newcastle	New South Wales
Australia	Sir Charles Gairdner Hospital	Perth	Western Australia
Australia	Royal Prince Alfred Hospital	Sydney	New South Wales
Australia	St Vincent's Hospital	Sydney	New South Wales
Australia	Westmead Hospital	Westmead	New South Wales
China	Hospitals in China, c/o The George Institute China	Beijing
China	Regional Coordinating Centre: Peking University First Hospital	Beijing
China	Regional Coordinating Centre: Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai Institute of Hypertension, Shanghai Second Medical University	Shanghai
New Zealand	North Shore Hospital	Auckland
New Zealand	Christchurch Hospital	Christchurch

Sponsors (2)

Lead Sponsor	Collaborator
The George Institute	National Health and Medical Research Council, Australia

Countries where clinical trial is conducted

Australia,  China,  New Zealand, 

References & Publications (1)

Anderson CS, Huang Y, Wang JG, Arima H, Neal B, Peng B, Heeley E, Skulina C, Parsons MW, Kim JS, Tao QL, Li YC, Jiang JD, Tai LW, Zhang JL, Xu E, Cheng Y, Heritier S, Morgenstern LB, Chalmers J; INTERACT Investigators. Intensive blood pressure reduction i — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combination death and dependency, according to a 3-6 scores on the modified Rankin Score.		3 months
Secondary	All cause and cause-specific early neurological deterioration during the first 72 hours; haematoma expansion & cerebral oedema at 24 & 72 hours; ; functional disability; cognitive function; quality of life; mortality at 1 and 3 months		24 and 72 hours, 1 and 3 months

External Links

•   For further information please see The George Institute for International health's website.