Antihypertensive Treatment in Acute Cerebral Hemorrhage
NCT ID: NCT00415610
Last Updated: 2017-11-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
60 participants
INTERVENTIONAL
2005-07-31
2008-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tier 1
Dose escalation:
The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine to a range between 170 to 200 mmHg. Treatment with nicardipine must begin within 6 hours of symptom onset and will continue for an estimated 18 - 24 hours, until SBP is stabilized. The assigned SBP range will be maintained for 24 hours. After 24 hours, management of blood pressure is at the discretion of the primary physician.
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.
Tier 2
Dose escalation:
The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine to a range between 140 to 170 mmHg. Treatment with nicardipine must begin within 6 hours of symptom onset and will continue for an estimated 18 - 24 hours, until SBP is stabilized. The assigned SBP range will be maintained for 24 hours. After 24 hours, management of blood pressure is at the discretion of the primary physician.
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.
Tier 3
Dose escalation:
The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine to a range between 110 to 140 mmHg. Treatment with nicardipine must begin within 6 hours of symptom onset and will continue for an estimated 18 - 24 hours, until SBP is stabilized. The assigned SBP range will be maintained for 24 hours. After 24 hours, management of blood pressure is at the discretion of the primary physician.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Adnan I. Qureshi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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University of Southern California
Los Angeles, California, United States
Kansas University Medical Center
Kansas City, Kansas, United States
The University of Kansas School of Medicine, Wichita Via Christi Regional Medical Center
Kansas City, Kansas, United States
Massachusetts General/Brigham Women's Hospital
Boston, Massachusetts, United States
Clinical Coordinating Center: University of Minnesota, Fairview Hospital
Minneapolis, Minnesota, United States
Saint Louis University
St Louis, Missouri, United States
JFK Medical Center
Edison, New Jersey, United States
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
Case Western Reserve University
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Statistical Coordinating Center: Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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References
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Qureshi AI. Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH): rationale and design. Neurocrit Care. 2007;6(1):56-66. doi: 10.1385/ncc:6:1:56.
Qureshi AI, Palesch YY, Martin R, Novitzke J, Cruz-Flores S, Ehtisham A, Ezzeddine MA, Goldstein JN, Hussein HM, Suri MF, Tariq N; Antihypertensive Treatment of Acute Cerebral Hemorrhage Study Investigators. Effect of systolic blood pressure reduction on hematoma expansion, perihematomal edema, and 3-month outcome among patients with intracerebral hemorrhage: results from the antihypertensive treatment of acute cerebral hemorrhage study. Arch Neurol. 2010 May;67(5):570-6. doi: 10.1001/archneurol.2010.61.
Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH) investigators. Antihypertensive treatment of acute cerebral hemorrhage. Crit Care Med. 2010 Feb;38(2):637-48. doi: 10.1097/CCM.0b013e3181b9e1a5.
Qureshi AI. Acute hypertensive response in patients with stroke: pathophysiology and management. Circulation. 2008 Jul 8;118(2):176-87. doi: 10.1161/CIRCULATIONAHA.107.723874. No abstract available.
Qureshi AI, Palesch YY, Martin R, Novitzke J, Cruz Flores S, Ehtisham A, Goldstein JN, Kirmani JF, Hussein HM, Suri MF, Tariq N; Antihypertensive Treatment of Acute Cerebral Hemorrhage Investigators. Systolic blood pressure reduction and risk of acute renal injury in patients with intracerebral hemorrhage. Am J Med. 2012 Jul;125(7):718.e1-6. doi: 10.1016/j.amjmed.2011.09.031. Epub 2012 May 4.
Qureshi AI, Palesch YY. Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH) II: design, methods, and rationale. Neurocrit Care. 2011 Dec;15(3):559-76. doi: 10.1007/s12028-011-9538-3.
Hussein HM, Tariq NA, Palesch YY, Qureshi AI; ATACH Investigators. Reliability of hematoma volume measurement at local sites in a multicenter acute intracerebral hemorrhage clinical trial. Stroke. 2013 Jan;44(1):237-9. doi: 10.1161/STROKEAHA.112.667220. Epub 2012 Dec 11.
Other Identifiers
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0609M93128
Identifier Type: -
Identifier Source: org_study_id