Antihypertensive Treatment in Acute Cerebral Hemorrhage (ATACH)

Inclusion Criteria:

• Age older than 18 years.
• Onset of new neurological signs of a stroke within 12 hours of the time to evaluation AND initiation of treatment with intravenous nicardipine.
• Clinical signs consistent with the diagnosis of stroke, including impairment of language, motor function, cognition, and/or gaze, vision, or neglect.
• The total GCS score is greater than 8 at the time of enrollment.
• CT scan demonstrates intraparenchymal hematoma with manual hematoma volume measurement less than 60 cc.
• ICH is supratentorial and is located in lobar, basal ganglionic, or thalamic based on the initial CT scan appearance.
• Admission systolic blood pressure greater than 170 mm Hg on two repeat measurements at least 5 minutes apart.
• Evidence of chronic hypertension.
• Subject is not considered a surgical candidate by the neurosurgery service.

Exclusion Criteria:

• Time of symptom onset cannot be reliably assessed.
• Previously known neoplasms, arteriovenous malformation, or aneurysms.
• Intracerebral hematoma considered to be related to trauma by the neurologist or neurosurgeon.
• ICH is located in the cortex or infratentorial regions such as pons or cerebellum.
• Blood is visualized in the subarachnoid space.
• Intravenous nicardipine cannot be initiated within 12 hours of symptom onset.
• Use of clonidine hydrochloride and other central alpha-agonist within the last 48 hours that have the potential of withdrawal hypertension.
• Pregnancy, lactation, or parturition within previous 30 days.
• Any history of bleeding diathesis or coagulopathy, including the use of warfarin.
• Use of heparin in the previous 48 hours and a prolonged partial thromboplastin time.
• Known atrial-ventricular heart block other than first degree, or sick sinus syndrome without a pacemaker.
• Intolerance to calcium channel blockers.
• Exposure to study medication in the preceding 24 hours prior to enrollment.
• A platelet counts less than 100 000/mm3.
• Major surgery within the previous six weeks.
• History of any intracranial hemorrhage (including intracerebral or subarachnoid hemorrhage) or hemorrhagic stroke.
• Seizure at onset of stroke.
• Blood glucose less than 50 mg/dL or greater than 400 mg/dL.
• Current participation in another research drug treatment protocol.
• Isolated ventricular blood on CT scan.
• Subject has a living will that precludes aggressive intensive care unit management.
• Subject has acute myocardial infarction or renal failure that precludes use of aggressive antihypertensive therapy.
• Subjects with unstable angina or acute myocardial infarction within 2 weeks prior to ICH.
• Subjects with renal insufficiency with serum creatinine greater than 2.0 mg/dl or on renal dialysis.
• Sinus tachycardia exceeding 120 beats per minute or supraventricular tachycardia is observed during initial evaluation.
• Ischemic stroke within 4 weeks of presentation.
• Congestive heart failure graded as class III and IV by New York Heart Association (NYHA) classification.