This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Antihypertensive Treatment of Acute Cerebral Hemorrhage-II (ATACH-II)

This study has been terminated.
(Planned interim analysis: no significant outcome differences between groups)
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Medical University of South Carolina
Johns Hopkins University
University of Michigan
Neurocritical Care Research Network
National Cerebral and Cardiovascular Center
Japan Cardiovascular Research Foundation
Beijing Tiantan Hospital
China Medical University Hospital
University Hospital Heidelberg
Seoul National University Hospital
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01176565
First received: August 4, 2010
Last updated: March 13, 2017
Last verified: March 2017
  Purpose

The specific aims of this study are to:

  1. Definitively determine the therapeutic benefit of the intensive treatment relative to the standard treatment in the proportion of patients with death and disability (mRS 4-6) at 3 months among subjects with ICH who are treated within 4.5 hours of symptom onset.
  2. Evaluate the therapeutic benefit of the intensive treatment relative to the standard treatment in the subjects' quality of life as measured by EuroQol at 3 months.
  3. Evaluate the therapeutic benefit of the intensive treatment relative to the standard treatment in the proportion of hematoma expansion (defined as increase from baseline hematoma volume of at least 33%) and in the change from baseline peri-hematoma volume at 24 hours on the serial computed tomographic (CT) scans.
  4. Assess the safety of the intensive treatment relative to the standard treatment in the proportion of subjects with treatment-related serious adverse events (SAEs) within 72 hours.

Condition Intervention Phase
Intracerebral Hemorrhage Drug: Intravenous nicardipine hydrochloride Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Eligible patients are randomized 1:1 via computer-generated treatment assignment within 4.5 hours of neurological symptom onset to either standard or intensive SBP management using intravenous nicardipine hydrochloride as the primary BP control agent through 24 hours from randomization. Enrolled patients from both treatment arms are otherwise treated similarly after 24 hours, according to their medical needs. Standards of care management for spontaneous intracerebral hemorrhage published in the 2010 American Heart Association guidelines are incorporated in to the study protocol. All enrolled patients are followed through 90 days (± 14 days per protocol window; up to ± 30 days data is used) unless death or withdrawal occurs sooner. Primary analysis based on intent-to-treat (ITT) principles.
Masking: Investigator, Outcomes Assessor
Masking Description:
The trial intervention is conducted open-label to avoid concealing clinically necessary patient blood pressure and intravenous drug administration information. Clinical data including SBP values are primarily taken from entries recorded in to the patient's official medical record by hospital staff and are independently monitor-verified. Assessors for the primary outcome (mRS) at 90 days are are unaware of the treatment assignment or in-hospital clinical course of the subjects assessed. De-identified imaging studies are coded independently of subject number so the central imaging reader is unaware of the treatment assignment, clinical findings, or time points of image acquisition for data recorded from imaging. The study (lead) principal investigator and leadership committee members are unable to associate the treatment assignment of subjects to their outcomes or adverse events for purposes of trial decision-making. Adverse events are adjudicated by an independent oversight committee.
Primary Purpose: Treatment
Official Title: Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH)-II: A Phase III Randomized Multicenter Clinical Trial of Blood Pressure Reduction for Hypertension in Acute Intracerebral Hemorrhage

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Death or Disability According to Modified Rankin Scale Score at 90 Days (3 Months) From Randomization [ Time Frame: 90 days (± 14 days per protocol window; up to ± 30 days data is used) from randomization ]
    The primary outcome was death or disability, defined by modified Rankin scale (mRS) of 4-6 at 90 days following treatment. The modified Rankin Scale score ranges from 0, indicating no symptoms, to 6, indicating death. A score of 4 indicates moderately severe disability including the inability to walk or attend to one's own bodily needs. A score of 5 indicates severe disability; bedridden, incontinent, and requiring constant nursing care. To score a 3 or lower on the mRS, a person must at least be able to walk without the assistance of another person. We chose the mRS because of its high inter-observer reliability, superiority to other indices, and consistency with previous trials in patients with ICH. Reliability was further increased by use of a structured interview template and by requiring mRS assessors to pass a certification test. Persons conducting the 90-day mRS assessment were to be unaware of the treatment arm or clinical course of the patients they assessed.


Secondary Outcome Measures:
  • Quality of Life at 90 Days Using EuroQol (EQ) Measures: EQ-5D (EuroQol Five Dimension), Consisting of Standardized EQ-5D-3L (EuroQol Five Dimension, Three-Level) Questionnaire and EQ VAS (EuroQol Visual Analog Scale) Scores [ Time Frame: 90 days (± 14 days per protocol window; up to ± 30 days data is used) from randomization ]
    Standardized scales developed by the EuroQol Research Foundation were used as a secondary outcome measure in addition to the mRS scale score. The EQ-5D is a simple, standardized non-disease-specific instrument for describing and valuating health-related quality of life. The EQ-5D-3L questionnaire consists of 5 questions in 5 different domains and allows for responses from 1 (the best outcome) to 3 (the worst outcome) in each of five categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Total scores range from 5 to 15, with lower scores indicating better quality of life and a higher score indicating a worse quality of life. A second component of EuroQol outcome measurements is a printed 20 cm visual analogue scale (EQ VAS) that appears somewhat like a thermometer, on which a score from 0 (worst imaginable health state or death) to 100 (best imaginable health state) is marked by the patient (or, when necessary, their proxy) with the scale in view.

  • Hematoma Expansion (Number of Patients With Hematoma Expansion of 33% or Greater Between the Baseline and 24 +/- 6 Hours Head CTs, as Measured by the Central Reader for Patients With Readable Scans for Both Time Points Submitted by Data Lock.) [ Time Frame: From the baseline head CT to the 24 +/- 6 hours from randomization head CT ]
    Hematoma expansion as determined by serial CT scans: Hematoma expansion was defined as an increase in the volume of intraparenchymal hemorrhage of 33% or greater as measured by a central imaging analyst who was was unaware of the treatment assignments, clinical findings, and time points of image acquisition. The area of the hematoma was delineated by image analysis software with the use of density thresholds on each slice, followed by manual correction. To ensure accuracy and consistency of the readings, images were coded randomly and independently of subject numbers and manual correction was also done without awareness of treatment assignments, clinical findings, or time points of image acquisition. This data point is defined as being present (hematoma expansion of 33% or more was calculated between the baseline scan hematoma volume and the 24 +/- 6 hours hematoma volume measures at data analysis), meaning that hematoma expansion as defined must have occurred or it was not counted.


Other Outcome Measures:
  • Neurological Deterioration Within 24 Hours, Defined by a Decrease of 2 or More Points on the GCS Score or an Increase of 4 or More Points on the NIHSS Score From Baseline, Not Related to Sedation or Hypnotic-agent Use and Sustained for at Least 8 Hours. [ Time Frame: From randomization through the 24-hour treatment period ]
    Neurologic deterioration was measured using two scales. The Glasgow Coma Scale (GCS) score measures of level of consciousness in eye, motor, and verbal components. At least one point is given in each category. The scale ranges from 3 to 15, with 3 indicating deep unconsciousness and 15 indicating consciousness is not impaired. The National Institutes of Health Stroke Scale (NIHSS) quantifies neurologic deficits in 11 categories. Level of consciousness, horizontal eye movement, visual fields, facial palsy, movement in each limb, sensation, language & speech, and extinction or inattention on one side of the body are tested. Scores range from 0 to 42, with 0 indicating normal function and higher scores indicating greater deficit severity. Neurological status was checked per ICU standards through 24 hours, recommended as hourly GCS and full assessment every 2 hours. NIHSS assessment at baseline and 24 +/- 3 hours was pre-specified. Assessments were added for suspected neurological change.

  • Hypotension Within 72 Hours [ Time Frame: From randomization through 72 hours from randomization ]
    Hypotension (abnormally low blood pressure) was the most likely adverse event that could be associated with the study treatment, and is the primary basis (risk) on which neurological deterioration or other untoward effects of the study treatment could occur. It is therefore examined as a numerically-measured occurrence in addition to monitoring patients closely for neurological deterioration or other symptoms. Hypotension, when named as an adverse event, was defined as the syndrome of low blood pressure with SBP < 85 mmHg. Instances of hypotension were to be avoided through close monitoring, and administration of fluid bolus for SBP < 110 mmHg. If hypotension did occur, it was to be reversed as quickly as possible through discontinuation of intravenous nicardipine and intravenous fluid administration, which can be accomplished readily in a variety of settings where patients with intracerebral hemorrhage are routinely housed during early hospitalization.

  • Treatment-related Serious Adverse Event Within 72 Hours of Randomization [ Time Frame: From randomization through 72 hours (3 days) ]
    Adverse events (AEs) and serious adverse events (SAEs) were assessed by the site investigators for all patients, including for their potential relatedness to the study treatment. An Independent Oversight Committee (IOC) reviewed and adjudicated all adverse event data. The 72-hours-from-randomization time window was considered the most likely time frame during which treatment-related adverse events or serious adverse events would be observed. Terminology from the Medical Dictionary for Regulatory Activities (MedDRA) and severity criteria from the Common Terminology Criteria for Adverse Events (CTCAE v. 4.03) were used as a basis for reporting adverse events. Serious adverse events are defined as being fatal, life-threatening, resulting in hospitalization or prolonged hospitalization, resulting in disability or congenital anomaly, or requiring intervention to prevent permanent impairment or damage and were required to be reported promptly.

  • Any Serious Adverse Event Within the 90-day Study Period [ Time Frame: From randomization through the 90 day visit (90 ± 14 days per protocol window; up to ± 30 days data is used) or until known death, withdrawal, or loss to follow-up. ]
    The complete count of all subjects who experienced any serious adverse events throughout their participation in the trial was included in this tabulation. Adverse events (AEs) and serious adverse events (SAEs) were assessed by the site investigators for all patients. Potential relatedness to the study treatment was a required reporting element for all adverse events but was not considered in this count. Terminology from the Medical Dictionary for Regulatory Activities (MedDRA) and severity criteria from the Common Terminology Criteria for Adverse Events (CTCAE v. 4.03) were used as a basis for reporting adverse events. Serious adverse events are defined as being fatal, life-threatening, resulting in hospitalization or prolonged hospitalization, resulting in disability or congenital anomaly, or requiring intervention to prevent permanent impairment or damage and were required to be reported promptly. An Independent Oversight Committee (IOC) reviewed and adjudicated adverse event data.


Enrollment: 1000
Actual Study Start Date: May 15, 2011
Study Completion Date: March 8, 2016
Primary Completion Date: December 21, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard SBP Reduction Arm

Intravenous nicardipine hydrochloride will be used as necessary (pro re nata or "PRN") as the primary agent in lowering SBP.

The goal for the standard BP reduction group will be to reduce and maintain SBP < 180 mmHg for 24 hours from randomization. 160 mmHg is the target SBP for this arm.

For the standard group, SBP below the assigned treatment range is not artificially elevated to stay within the range if lower SBP occurs with nicardipine turned off (no fluid bolus given unless SBP falls below 110 mmHg with nicardipine off and there is risk for hypotension). Euvolemic fluid maintenance is encouraged for all patients according to their medical needs, which may differ.

Drug: Intravenous nicardipine hydrochloride

IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached. If SBP is above the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent may be used (Labetalol 5-20 mg IV bolus every 15 min; diltiazem/urapidil in countries without labetalol) for another hour. Nicardipine infusion is decreased incrementally or is stopped if SBP falls below the desired treatment range.

Fluid bolus for SBP still falling below 110 mmHG (millimeters of mercury) with nicardipine off is given to prevent organ hypoperfusion. Vasopressor agents are not used unless symptoms related to or possibly exacerbated by hypoperfusion are present.

Other Names:
  • Cardene® I.V.
  • Nicardipine HCl injection
  • nicardipine hydrochloride injection
  • nicardipine IV
  • nicardipine
  • nicardipine hydrochloride
Active Comparator: Intensive SBP Reduction Arm

Intravenous nicardipine hydrochloride will be used as necessary (pro re nata or "PRN") as the primary agent in lowering SBP.

The goal for the intensive BP reduction group will be to reduce and maintain SBP < 140 mmHg for 24 hours from randomization. 125 mmHg is the target SBP for this arm.

For the intensive group, SBP falling below 110 mmHg (lower limit of the assigned treatment range) with nicardipine off is treated with normal saline fluid bolus to prevent or remedy hypotension. Euvolemic fluid maintenance is encouraged for all patients according to their medical needs, which may differ.

Drug: Intravenous nicardipine hydrochloride

IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached. If SBP is above the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent may be used (Labetalol 5-20 mg IV bolus every 15 min; diltiazem/urapidil in countries without labetalol) for another hour. Nicardipine infusion is decreased incrementally or is stopped if SBP falls below the desired treatment range.

Fluid bolus for SBP still falling below 110 mmHG (millimeters of mercury) with nicardipine off is given to prevent organ hypoperfusion. Vasopressor agents are not used unless symptoms related to or possibly exacerbated by hypoperfusion are present.

Other Names:
  • Cardene® I.V.
  • Nicardipine HCl injection
  • nicardipine hydrochloride injection
  • nicardipine IV
  • nicardipine
  • nicardipine hydrochloride

Detailed Description:
The report from a National Institute of Neurological Disorders and Stroke Workshop on priorities for clinical research in intracerebral hemorrhage (ICH) in December 2003 recommended clinical trials for evaluation of blood pressure (BP) management in acute ICH as a leading priority. The Special Writing Group of the Stroke Council of the American Heart Association in 1999 and 2007 emphasized the need for clinical trials to ensure evidence-based treatment of acute hypertension in ICH. Consequently, we propose to conduct a five-year international, multicenter, open-labeled, randomized, controlled, Phase III trial to determine the efficacy of early, intensive antihypertensive treatment using intravenous nicardipine for acute hypertension in subjects with co-morbid hypertension and spontaneous supratentorial ICH. The primary hypothesis of this large, streamlined, focused trial is that the group treated with intensive BP reduction (systolic BP [SBP] of 140 mmHg or less - hereafter referred to as the intensive treatment) using intravenous nicardipine infusion for 24 hours reduces the proportion of death and disability at 3 months by 10% or greater compared with the group treated with the standard BP reduction (SBP of 180 mmHg or less - hereafter referred to as the standard treatment) among patients with ICH treated within 4.5 hours of symptom onset. The underlying mechanism for this expected beneficial effect of intensive treatment is mediated through reduction of the rate and magnitude of hematoma expansion observed in approximately 38% of patients with acute ICH. The trial will recruit a maximum of 1,280 subjects with ICH who meet the eligibility criteria. The primary outcome is the proportion of death and disability at 3 months defined by modified Rankin scale (mRS) score of 4 to 6. The proposed clinical trial is the natural extension of numerous case series, a subsequent pilot trial funded by the National Institutes of Health National Institute of Health (NIH), and a preliminary randomized controlled trial in this patient group funded by the Australian National Health and Medical Research Council, that have recently confirmed the safety and tolerability of both the regimen and goals of the antihypertensive treatment in acutely hypertensive patients with ICH proposed in the present trial. The proposed trial will have important public health implications by providing necessary information regarding the efficacy and safety of antihypertensive treatment of acute hypertension observed in up to 75% of the subjects with ICH. BP treatment represents a strategy that can be made widely available without the need of specialized equipment and personnel and therefore can make a major impact upon outcome in patients with ICH. Substantial reduction in morbidity and mortality appears possible if the estimates of treatment effect sizes from current pilot trials are accurate.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years or older
  • IV nicardipine can be initiated within 4.5 hours of symptom onset.
  • Clinical signs consistent with the diagnosis of stroke, including impairment of language, motor function, cognition, and/or gaze, vision, or neglect.
  • Total Glasgow Coma Scale (GCS) score (aggregate of verbal, eye, and motor response scores) of 5 or greater at time of emergency department (ED) arrival.
  • International normalized ratio (INR) value < 1.5
  • CT scan demonstrates intraparenchymal hematoma with manual hematoma volume measurement <60 cc.
  • For subjects randomized prior to IV antihypertensive administration: SBP greater than 180 mmHg* prior to IV antihypertensive treatment (this includes pre-hospital treatment) AND WITHOUT spontaneous SBP reduction to below 180 mmHg at the time of randomization OR
  • For subjects randomized after IV antihypertensive administration: SBP greater than 180 mmHg* prior to IV antihypertensive treatment (this includes pre-hospital treatment) AND WITHOUT SBP reduction to below 140 mmHg at the time of randomization.
  • Informed consent obtained by subject, legally authorized representative, or next of kin.

    • Notes: The unit "mmHg" stands for "millimeters of mercury", a standard way of measuring blood pressure. Patients with SBP < 180 mmHg should be monitored for 4.5 hours from symptom onset as their SBP may rise to eligible levels before the eligibility window closes.

Exclusion Criteria:

  • ICH is due to previously known neoplasms, arteriovenous malformation (AVM), or aneurysms.
  • Intracerebral hematoma considered to be related to trauma.
  • ICH located in infratentorial regions such as pons or cerebellum.
  • Intraventricular hemorrhage (IVH) associated with intraparenchymal hemorrhage and blood completely fills one lateral ventricle or more than half of both ventricles.
  • Patient to receive immediate surgical evacuation.
  • Current pregnancy, or parturition within previous 30 days, or active lactation.
  • Use of dabigatran within the last 48 hours**.
  • A platelet count less than 50,000 per microliter (µL or mm3)
  • Known sensitivity to nicardipine.
  • Pre-morbid disability requiring assistance in ambulation or activities of daily living.
  • Subject's living will precludes aggressive ICU management.
  • Subject is currently participating in another interventional clinical trial

    • Use of dabigatran was clarified through investigator presentations, educational materials, and clinical tools to include newer similar class medications (such as rivaroxaban, apixaban, and edoxaban) that were being developed and in various stages of approval across enrolling countries through the course of this trial, in the event that patients using these medications may have been encountered during screening.
  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: NCT01176565

  Hide Study Locations
Locations
United States, Alabama
UAB Comprehensive Stroke Center
Birmingham, Alabama, United States, 35249
United States, Arizona
Maricopa Medical Center
Phoenix, Arizona, United States, 85008
Mayo Clinic Pheonix
Scottsdale, Arizona, United States, 85259
Banner University Medical Center - South Campus
Tuscon, Arizona, United States, 85713
Banner University Medical Center - University Campus
Tuscon, Arizona, United States, 85724
United States, California
Community Regional Medical Center of Fresno
Fresno, California, United States, 93721
University of California San Diego
La Jolla, California, United States, 92093
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
Ronald Regan UCLA Medical Center
Los Angeles, California, United States, 90095-9574
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92658
Stanford University
Palo Alto, California, United States, 94304
Sutter Roseville Medical Center
Roseville, California, United States, 95661
UC Davis Medical Center
Sacramento, California, United States, 95817
UCSF Medical Center
San Francisco, California, United States, 94143
Good Samaritan Hospital
San Jose, California, United States, 95124
Santa Clara Valley Medical Center
Santa Clara, California, United States, 95138
United States, Colorado
Colorado Neurological Institute
Englewood, Colorado, United States, 80113
United States, Connecticut
Yale - New Haven Hospital
New Haven, Connecticut, United States, 06510
United States, Delaware
Christiana Hospital
Newark, Delaware, United States, 19718
United States, Florida
University of Florida Gainesville
Gainesville, Florida, United States, 32611
Baptist Medical Center Jacksonville
Jacksonville, Florida, United States, 32207
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
University of South Florida, Tampa General Hospital
Tampa, Florida, United States, 33612
United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Emory University Hospital
Atlanta, Georgia, United States, 30322
United States, Idaho
Eastern Idaho Medical Consultants
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Southern Illinois University Memorial Medical Center
Springfield, Illinois, United States, 62794-9643
United States, Indiana
Lutheran Hospital Indiana
Fort Wayne, Indiana, United States, 46804
Parkview Hospital
Fort Wayne, Indiana, United States, 46805
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536-0296
University of Louisville
Louisville, Kentucky, United States, 40292
United States, Louisiana
West Jefferson Medical Center
Marrero, Louisiana, United States, 70072
Interim LSU Hospital
New Orleans, Louisiana, United States, 70112
Tulane Medical Center
New Orleans, Louisiana, United States, 70112
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Louisiana State University Health Sciences Center, Shreveport
Shreveport, Louisiana, United States, 71103
United States, Maine
Maine Medical Center
South Portland, Maine, United States, 04106
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Michigan
Wayne State University - Detroit Receiving Hospital
Detroit, Michigan, United States, 48201
Henry Ford Health System
Detroit, Michigan, United States, 48202
Sinai-Grace Hospital
Detroit, Michigan, United States, 48235
Allegiance Health
Jackson, Michigan, United States, 49201
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Essentia Health St. Mary's Medical Center
Duluth, Minnesota, United States, 55805
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55404
St. Cloud Hospital
St. Cloud, Minnesota, United States, 56303
Regions Hospital
St.Paul, Minnesota, United States, 55101
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Saint Luke's Neuroscience Institute
Kansas City, Missouri, United States, 64111
Research Medical Center
Kansas City, Missouri, United States, 64132
Saint Louis University
Saint Louis, Missouri, United States, 63104
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
St. Joseph's Regional Medical Center
Clifton, New Jersey, United States, 07012
New Jersey Neuroscience Institute, JFK Medical Center
Edison, New Jersey, United States, 08818
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, New York
New York City Health and Hospitals Corp. / Kings County Hospital
Brooklyn, New York, United States, 11203
Mamoides Medical Center
Brooklyn, New York, United States, 11219
Sister of Charity/Buffalo Mercy Hospital, Catholic Health System
Buffalo, New York, United States, 14214
UHS Wilson Medical Center
Johnson City, New York, United States, 13790
North Shore University Hospital
Manhasset, New York, United States, 11030
SUNY Downstate
New York, New York, United States, 10029
Columbia University
New York, New York, United States, 10032
Lincoln Medical and Mental Health Center
New York, New York, United States, 10451
Rochester General Hospital
Rochester, New York, United States, 14621
Strong Stroke Center
Rochester, New York, United States, 14642
United States, North Carolina
Mission Hospital
Asheville, North Carolina, United States, 28801-4601
Guilford Neurologic Associates
Greenboro, North Carolina, United States, 27405
Vidant Medical Center
Greenville, North Carolina, United States, 27834
Novant Clinical Research Institute/Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
Wake Forest Baptist Medical Center (Wake Forest School of Medicine)
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Akron General Hospital
Akron, Ohio, United States, 44307
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Ohio State University - Wexner Medical Center
Columbus, Ohio, United States, 43210
University of Toledo Medical Center
Toledo, Ohio, United States, 43614
United States, Oklahoma
Oklahoma University Health Sciences Center (OUHSC)
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Providence Brain and Spine Institute
Portland, Oregon, United States, 97225
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Lehigh Valley Health Network
Allentown, Pennsylvania, United States, 18103
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Penn State Univ/ Hershey Med Center
Hershey, Pennsylvania, United States, 17033
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States, 19102
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Temple University
Philadelphia, Pennsylvania, United States, 19140
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213
UPMC-Mercy Hospital
Pittsburgh, Pennsylvania, United States, 15219
Reading Hospital
West Reading, Pennsylvania, United States, 19611
Wellspan York Hospital
York, Pennsylvania, United States, 17403
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Palmetto Health
Columbia, South Carolina, United States, 29203
United States, Tennessee
Vanderbilt Stroke Center
Nashville, Tennessee, United States, 37232
United States, Texas
Seton Medical Center Austin
Austin, Texas, United States, 78705
St. David's Medical Center
Austin, Texas, United States, 78705
University Medical Center Brackenridge
Austin, Texas, United States, 78705
UT Southwestern - Parkland Hospital
Dallas, Texas, United States, 75235
Texas Tech University Health Sciences Center
El Paso, Texas, United States, 79430
Valley Baptist Medical Center
Harlingen, Texas, United States, 78550
Memorial Herman - Texas Medical Center
Houston, Texas, United States, 77024
Baylor College of Medicine - Ben Taub Community Hospital
Houston, Texas, United States, 77030
Baylor College of Medicine - St. Luke's Episcopal Hospital
Houston, Texas, United States, 77030
Methodist Hospital - The Neurological Institute
Houston, Texas, United States, 77030
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84107
United States, Virginia
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298-0631
United States, West Virginia
West Virginia University - Ruby Memorial Hospital
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Medical College of Wisconsin
Milwakee, Wisconsin, United States, 53226
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, 2E3.27WMC
Canada, Quebec
Montreal Neurological Institute and Hospital
Montreal, Quebec, Canada, H3A 2B4
China, Hebei
The Second Hospital of Hebei Medical University
Shijiazhuang City, Hebei, China, 050000
China, Shanxi
The Second Hospital of Shanxi Medical University
Taiyuan City, Shanxi, China, 030001
China
Baotou Central Hospital
Baotou, China
Beijing Tiantan Hospital
Beijing, China, 100050
Peking University Third Hospital
Beijing, China, 100191
Datong Third People's Hospital
Datong, China
The First Hospital of Shanxi Medical University
Taiyuan City, China, 030001
The First People's Hospital of Taizhou
Taizhou City, China, 318020
Tianjin Fourth Central Hospital
Tianjin, China, 300140
Wuhan Brain Hospital
Wuhan, China, 430019
Renmin Hospital of Wuhan University
Wuhan, China, 430060
People's Hopital of Zhengzhou
Zhengzhou, China, 450003
Germany
Charité Universtity Medicine Berlin
Berlin, Germany, 12203
University of Bonn
Bonn, Germany, 53105
University Hospital Dresden
Dresden, Germany, 01307
Clinic Frankfurt Hoechst
Frankfurt, Germany, 65929
University Hospital Halle
Halle (Saale), Germany, 06120
University Hospital Heidelberg
Heidelberg, Germany, 69120
University Hospital Leipzig
Leipzig, Germany, 04103
University Hospital Mannheim
Mannheim, Germany, 68167
University Hospital Meunster
Munster, Germany, 48129
University of Tubingen
Tubingen, Germany, 72076
Japan
Nagoya Medical Center
Nagoya City, Aichi, Japan, 460-0001
Nakamura Memorial Hospital
Sapporo, Hokkaido, Japan, 060-8570
Saiseikai Yokohamashi Tobu Hospital
Kanagawa, Kanagowa, Japan, 230-8765
Saiseikai Kumamoto Hospital
Kumamoto City, Kumamoto, Japan, 861-4193
Kyushu Medical Center
Fukuoka, Japan, 810-8563
Gifu University Hospital
Gifu, Japan, 501-1194
St. Marianna - Toyoko
Kawasaki, Japan, 211-0063
St. Marianna University Hospital
Kawasaki, Japan, 216-8511
Kobe City Medical Center General Hospital
Kobe City, Japan
Kawasaki Medical School
Okayama, Japan, 701-0192
National Cerebral and Cardiovascular Center
Osaka, Japan, 565-8565
Kohnan Hospital
Sendai, Japan
Toranomon Hospital
Tokyo, Japan, 105-8470
Saiseikai Central Hospital - Tokyo
Tokyo, Japan, 108-0073
Keio University Hospital
Tokyo, Japan, 160-8582
Kyorin University
Tokyo, Japan
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi, Korea, Republic of
Chonnam National University Hospital
Gwangju, Korea, Republic of, 501-757
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Kyung Hee University Hospital
Seoul, Korea, Republic of, 130-702
Seoul National University Boramae Hospital
Seoul, Korea, Republic of, 156-707
Taiwan
Changhua Christian Hospital
Changhua, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
Kaohsiung Medical University Hospital
Kaohsiung, Taiwan, 807
Taichung Veterans General Hopital
Taichung City, Taiwan, 407
China Medical University Hospital
Taichung, Taiwan, 404
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Shin-Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan, 111
Tri-Service General Hospital
Taipei, Taiwan, 114
Taipei Veteran's Hospital
Taipei, Taiwan
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Medical University of South Carolina
Johns Hopkins University
University of Michigan
Neurocritical Care Research Network
National Cerebral and Cardiovascular Center
Japan Cardiovascular Research Foundation
Beijing Tiantan Hospital
China Medical University Hospital
University Hospital Heidelberg
Seoul National University Hospital
Investigators
Study Chair: Adnan I Qureshi, MD University of Minnesota - Clinical and Translational Science Institute
Study Director: Yuko Y Palesch, PhD Medical University of South Carolina
Principal Investigator: Adnan I Qureshi, MD University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Yuko Y Palesch, PhD Medical University of South Carolina
  More Information

Additional Information:
Publications:

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: Protocol

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01176565     History of Changes
Other Study ID Numbers: 1207M17921
U01NS062091 ( US NIH Grant/Contract Award Number )
U01NS061861 ( US NIH Grant/Contract Award Number )
U01NS059041 ( US NIH Grant/Contract Award Number )
U01NS056975 ( US NIH Grant/Contract Award Number )
H23-4-3 ( Other Grant/Funding Number: Intramural Research Fund for Cardiovascular Diseases of the National Cerebral and Cardiovascular Center, Japan )
Study First Received: August 4, 2010
Results First Received: January 1, 2017
Last Updated: March 13, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: A public use data set from the study database will be made available. A process for sharing subject head imaging studies that may be associated with the data set is under evaluation.

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Acute hypertensive response
intracerebral hemorrhage
blood pressure
outcome
nicardipine

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

ClinicalTrials.gov processed this record on June 26, 2017