Antihypertensive Treatment in Acute Cerebral Hemorrhage

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to evaluate the safety and effectiveness of lowering blood pressure using nicardipine in persons with acute hypertension associated with intracerebral hemorrhage.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Antihypertensive Agents; Nicardipine

Criteria

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.