Antihypertensive Treatment in Acute Cerebral Hemorrhage "ATACH"


Phase 1 Results

Eligibility 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.