Antihypertensive Treatment in Acute Cerebral Hemorrhage
Information source: National Institute of Neurological Disorders and Stroke (NINDS)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Intracerebral Hemorrhage; Hypertension; Stroke
Intervention: nicardipine (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: University of Minnesota Official(s) and/or principal investigator(s):
Adnan I. Qureshi, MD, Principal Investigator, Affiliation: University of Minnesota
Yuko Palesch, Ph.D., Affiliation: Study Statistician, Medical University of South Carolina
Jill Novitzke, RN, Affiliation: Clinical Coordinator, University of Minnesota
Catherine Dillon, Affiliation: Project Manager, Medical University of South Carolina
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.
Clinical Details
Official title: Antihypertensive Treatment in Acute Cerebral Hemorrhage (ATACH)
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary outcome: Tolerability, the ability to achieve reduction of blood pressure and maintain treatment goals (the specified systolic blood pressure range for the 18-24 hour period) without neurological deterioration or side effects
Secondary outcome: Safety, as determined by the amount of neurological deteriorations during the 24 hour treatment period, plus the number of serious adverse events
Detailed description:
An estimated 37,000 to 52,400 people in the United States have intracerebral hemorrhage (ICH)
every year. ICH——a form of stroke that has poor outcome and is difficult to treat——is
associated with the highest mortality rate of all strokes. Hematoma expansion has been
identified as the most common cause of neurological deterioration in persons with ICH. Early
evidence suggests that acute hypertension (HTN)—or elevated blood pressure—may make some
individuals more susceptible to hematoma expansion. Treating HTN acutely may prevent
hematoma expansion, however, the effect of aggressive HTN treatment has not been determined.
The purpose of this trial is to evaluate the treatment feasibility and safety of lowering
blood pressure using nicardipine——an antihypertensive medication——in persons who have acute
HTN associated with ICH.
This pilot study will enroll 60 individuals who qualify with a presenting systolic blood
pressure of at least 170 mmHg, have an ICH, and can be evaluated and treatment initiated
within 6 hours of onset of stroke symptoms. In a stepwise fashion, the scientists will
investigate the potential consequences of controlling blood pressure with intravenous
nicardipine at 3 sequential levels: 170 to 200 mmHg, 140 to 170 mmHg, and 110 to 140 mmHg.
Twenty participants will be enrolled per level.
Treatment will last 18 to 24 hours. Participants will stay in the hospital for about 7 days
(including 24 hours in the intensive care unit for close monitoring) and will return for
1-hour follow-up visits at 30 days and at 90 days after discharge from the hospital. During
these visits participants will receive neurological assessments to determine their functional
outcome. For participants, the study will be completed after the 90-day follow-up visit.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
University of Southern California, Los Angeles, California 90033, United States
Kansas University Medical Center, Kansas City, Kansas 66160, United States
The University of Kansas School of Medicine, Wichita Via Christi Regional Medical Center, Kansas City, Kansas 66160, United States
Massachusetts General/Brigham Women's Hospital, Boston, Massachusetts 02115, United States
Clinical Coordinating Center: University of Minnesota, Fairview Hospital, Minneapolis, Minnesota, United States
Saint Louis University, St. Louis, Missouri 63108, United States
University of Medicine and Dentistry of New Jersey, Newark, New Jersey 07107, United States
JFK Medical Center, Edison, New Jersey 08818, United States
Columbia University Medical Center, New York, New York 10032, United States
Ohio State University, Columbus, Ohio 43210, United States
Case Western Reserve University, Cleveland, Ohio 44106, United States
Statistical Coordinating Center: Medical University of South Carolina, Charleston, South Carolina 29425, United States
Additional Information
Starting date: July 2005
Ending date: May 2008
Last updated: December 28, 2007
|
