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.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

a. 18 years or older.
b. Acute stroke due to sponataneous ICH, confirmed by clinical history and CT scan.
c. At least 2 separate blood pressure measurements of systolic blood pressure >=150 mmHg, and <=220 mmHg.
d. Able to commence assigned blood pressure treatment within 6 hours of stroke onset.
e. Able to be actively treated (not moribund).
(zie pagina 17 van het protocol)

Exclusion Criteria

a. Known definite contraindication to an intensive BP lowering regimen (eg severe carotid, vertebral or cerebral arterial stenosis, known Moya Moya disease or Takayasu*s arteritis, high-grade stenotic valvular heart disease, or severe renal failure).
b. Known definite indication for an intensive BP lowering regimen that is similar or more intensive than the active treatment arm of this study (eg very high systolic BP >220 mmHg, hypertensive encephalopathy, or aortic dissection).
c. Definite evidence that the ICH is secondary to a structural abnormality in the brain (eg an AVM, intracranial aneurysm, tumour, trauma, or previous cerebral infarction) or previous thrombolysis.
d. Previous ischaemic stroke within 30 days.
e. A very high likelihood that the patient will die within the next 24 hours on the basis of clinical and/or radiological criteria (eg massive haematoma with mid-line shift of hemisphere or deep coma on presentation, defined by Glasgow Coma Scale Score of 3-5), (NB seizures occur commonly after the onset of ICH, so a reduction in the level of consciousness that isdisproportionate to the size of the haematoma may be secondary to epilepsy rather than mass effect from the ICH).
f. Known advanced dementia or significant pre-stroke disability (eg modified Rankin Score [mRS] of 3 or more).
g. Concomitant medical illness that would interfere with outcome assessments and follow-up (eg advanced cancer or respiratory disease).
h. Already booked for surgical evacuation of haematoma.
i. Previous participation in this trial or current participation in an investigational drug trial.
j. A high likelihood that the patient will not adhere to the study treatment and follow-up regimen.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome: the efficacy of the treatment regime will be evaluated on the<br /><br>combined endpoint of death<br /><br>and dependency at the end of follow-up. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Key secondary outcome: to assess efficacy of the primary outcome in those<br /><br>patients treated within 4 hours of ICH onset.<br /><br>Other secondary outcomes: to determine effects of treatment on (a) physical<br /><br>function, health-related quality of life, recurrent stroke and other vascular<br /><br>events, days of hospitalisation, and requirement for permanent residential<br /><br>care, and (b) other serious adverse events.</p><br>