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IV Double and Triple Concentrated Nicardipine for Stroke and ICH

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2006 by OSF Healthcare System.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
PDL BioPharma, Inc.
Information provided by:
OSF Healthcare System
ClinicalTrials.gov Identifier:
NCT00325793
First received: May 12, 2006
Last updated: NA
Last verified: May 2006
History: No changes posted
  Purpose
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.

Condition Intervention Phase
Hypertension
 Drug: Nicardipine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Prospective Study to Evaluate the Safety and Efficacy of Double or Triple Concentrated Intravenous Nicardipine for Treatment of Hypertension in Patients With Ischemic Stroke, Intracerebral Hemorrhage or Subarachnoid Hemorrhage

Resource links provided by NLM:

MedlinePlus related topics: Bleeding
U.S. FDA Resources

Further study details as provided by OSF Healthcare System:

Primary Outcome Measures:
  • • Demonstrate the feasibility and safety of double and triple concentrated peripheral intravenous Nicardipine for patients in the Neuroscience Critical Care Unit.

Secondary Outcome Measures:
  • Time and dosage adjustment needed to reach the target BP range
  • Safety
  • To evaluate the tolerance of the double or triple concentrated Nicardipine
Estimated Enrollment: 50
Study Start Date: January 2004
Detailed Description:

Hypertension can often cause neurological worsening in patients with either ICH or SAH. Hypertension has been related to increased incidence of intracranial hemorrhage in patients who are treated with thrombolytics or on anticoagulation. Timely control of hypertension is directly related to the outcome of these patients. Furthermore, unlike in the conditions of hypertensive emergency or urgency, gentle titration to control the blood pressure is recommended in patients with either ischemic cerebral infarction or hemorrhage. Therefore the ideal agent to control hypertension in these patients would have these characteristics:

  • Rapid onset of action
  • Predictable dose response
  • Titratable to desired BP
  • Minimal dosage adjustments
  • Minimal adverse effects
  • No increase in INTRACRANIAL PRESSURE (ICP)
  • Easy transition to oral formulation for long-term maintenance

Currently, only IV sodium nitroprusside, nitroglycerine, enalapril and esmolol are used for controlling blood pressure in patients with IS, ICH and SAH. These agents are difficult to titrate and may potentially be harmful to brain cells.

Nicardipine offers several advantages in blood pressure control. It may cause dilatation of the coronary vessels while has no effect on cardiac conduction. It is not associated with coronary steal. As the only IV calcium channel blocker approved for the treatment of hypertension, nicardipine is vasoselective, and has a rapid onset and precisely controllable in a variety of patient types. It is as effective as sodium nitroprusside with fewer dose adjustments. It has documented safety with a low incidence of side effects. It requires minimal dose adjustments.

The disadvantage of Nicardipine IV drip is the relative large volume of fluid needed (up to 150 cc/hr). In patients with ischemic cerebral stroke (IS) or hemorrhage (ICH), intravenous infusion of large volume can contribute to cerebral edema or increase in intracranial pressure (ICP). If the infusion of nicardipine can be double or triple concentrated without the need of a central line, it not only offers titratable BP control, but also less overall volume to infuse the drug.

This is a phase IV prospective, open-label, dose regimen study of double or triple concentration nicardipine infusion for controlling blood pressure in patients with either ischemic cerebral infarction (IS) or intracerebral hemorrhage (ICH) or subarachnoid hemorrhage (SAH). Once the patient has the need for rapid control of blood pressure, he or she will be eligible for the study. The first 25 patients will be consented for the double dose treatment and the next 25 patients will be consented for the triple dose treatment. The patient will be followed during the infusion period for efficacy and safety.

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325793

Contacts
Contact: David Wang, DO 309-624-9500 dwang@uic.edu

Locations
United States, Illinois
OSF Stroke Center Recruiting
Peoria, Illinois, United States, 61637
Principal Investigator: David Wang, DO         
Sponsors and Collaborators
OSF Healthcare System
PDL BioPharma, Inc.
Investigators
Principal Investigator: David Wang, DO OSF Stroke Center
  More Information

ClinicalTrials.gov Identifier: NCT00325793     History of Changes
Other Study ID Numbers: 0012003 
Study First Received: May 12, 2006
Last Updated: May 12, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by OSF Healthcare System:
nicardipine
hypertension
intracerebral hemorrhage
ischemic stroke

Additional relevant MeSH terms:
Hypertension
Cerebral Hemorrhage
Vascular Diseases
Cardiovascular Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Hemorrhage
Pathologic Processes
Nicardipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on September 26, 2016