Intervention: Nicardipine
Trial phase: Phase 1
ATC code: C08CA04
SMILES: COC(=O)C1=C(C)NC(C)=C(C(=O)OCCN(C)Cc2ccccc2)C1c1cccc([N+](=O)[O-])c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Dose escalation:

The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 140 to 170 mmHg

Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.

Started at 5mg/h
Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.

The DSMB will review safety, tolerability, and feasibility before escalation to the next level.
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.