Overview

IV Double and Triple Concentrated Nicardipine for Stroke and ICH

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
Hypertension (high blood pressure) can often cause neurological worsening in patients with stroke, intracerebral hemorrhage and subarachnoid hemorrhage. Intravenous infusion of nicardipine (Cardene) for control of hypertension is FDA approved. The disadvantage of Nicardipine IV drip is the relative large volume of fluid needed (up to 150 cc/hr). The purpose of this study is to evaluate safety and efficacy of double or triple concentrated peripheral intravenous (IV) Nicardipine.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
OSF Healthcare System
Collaborator:
PDL BioPharma, Inc.
Treatments:
Nicardipine
Criteria
Inclusion Criteria:

- Males or females, 18 years of age or older.

- Acute ischemic cerebral stroke (IS) with uncontrollable hypertension that may need to
be controlled for the purpose of considering thrombolytic therapy or anticoagulation
therapy.

- Intracerebral hemorrhagic (ICH) stroke patients, including subarachnoid hemorrhage
(SAH) (surgically treated or not), any territory with an appropriate study (head CT
scan or MRI scan) providing results consistent with this diagnosis, who may require
the control of hypertension or control of blood pressure.

Exclusion Criteria:

- Allergy to Nicardipine or known hypersensitivity to Nicardipine.

- Chronic renal failure or Creatinine blood sample levels> 2.0.

- Impaired hepatic function defined as a two times value of liver enzymes.

- Severe left ventricular dysfunction defined as ventricular ejection fraction < 30%.

- Patients or authorized representative who refused be enrolled into this study.

- Advanced aortic stenosis.

- Pregnant or nursing women will not be enrolled in this study.

- No patient will be allowed to be enrolled in this study more than once.

- Patients may not be enrolled into other clinical studies during their involvement with
this study.