Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage
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| ClinicalTrials.gov Identifier: NCT00226096 |
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Recruitment Status :
Completed
First Posted : September 26, 2005
Last Update Posted : June 26, 2008
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| CVA (Cerebrovascular Accident) Cerebral Hemorrhage Intracranial Hemorrhages | Drug: Labetalol Hydrochloride Drug: Metoprolol tartrate Drug: Hydralazine Hydrochloride Drug: Glycerol Trinitrate Drug: Phentolamine mesylate Drug: Nicardipine Drug: Urapidil Drug: Esmolol Drug: Clonidine Drug: Enalaprilat Drug: Nitroprusside | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 404 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | November 2005 |
| Actual Primary Completion Date : | September 2007 |
| Actual Study Completion Date : | September 2007 |
- Combination death and dependency, according to a 3-6 scores on the modified Rankin Score. [ Time Frame: 3 months ]
- 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 [ Time Frame: 24 and 72 hours, 1 and 3 months ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00226096
Show 20 study locations
| Principal Investigator: | Craig Anderson, PhD | The George Institute | |
| Principal Investigator: | Bruce Neal, PhD | The George Institute |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00226096 |
| Other Study ID Numbers: |
NDA1INTERACT |
| First Posted: | September 26, 2005 Key Record Dates |
| Last Update Posted: | June 26, 2008 |
| Last Verified: | June 2008 |
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Clinical Trial Blood Pressure CVA (Cerebrovascular Accident) |
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Stroke Intracranial Hemorrhages Cerebral Hemorrhage Hemorrhage Pathologic Processes Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Metoprolol Clonidine Nitroprusside Labetalol |
Hydralazine Nicardipine Phentolamine Urapidil Enalaprilat Nitroglycerin Esmolol Glycerol Anti-Arrhythmia Agents Antihypertensive Agents Sympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic beta-1 Receptor Antagonists |