Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH-II)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Collaborators:
Medical University of South Carolina
Johns Hopkins University
University of Michigan
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01176565
First received: August 4, 2010
Last updated: April 22, 2015
Last verified: April 2015
  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 > 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: Nicardipine hydrochloride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH-II)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • A pragmatic, streamlined randomized design to evaluate the efficacy of intensive SBP reduction and its effect on outcomes measures at 24 h and at 3 m from randomization in subjects with ICH [ Time Frame: August, 2010- July 2015 ] [ Designated as safety issue: No ]
    Primary outcome is death or disability, defined by modified Rankin scale (mRS) of 4-6 at 3 m following treatment. We chose the mRS because of its high inter-observer reliability, superiority to other indices (e.g., Barthel index), and consistency with previous trials in patients with ICH. Further reliability will be increased by training raters in using the structured interview and obtaining a mRS grade. A dichotomous outcome was chosen to reduce the rate of misclassification and increase the sensitivity of detecting meaningful difference.


Secondary Outcome Measures:
  • Secondary outcomes [ Time Frame: August, 2010- July 2015 ] [ Designated as safety issue: No ]

    EuroQOL: EuroQOL (EQ) is a simple, standardized non-disease-specific instrument for describing and valuating health-related quality of life. Its components are a printed 'thermometer'-type visual analogue scale and EQ-5D, which consists of 5 questions in 5 different domains and allows for responses from 1 (the best outcome) to 3 (the worst).

    Hematoma expansion as determined by serial CT scans: Hematoma expansion will be defined as an increase in the volume of intraparenchymal hemorrhage of >33% as measured by image analysis on the 24-h CT compared with the baseline CT scan.



Estimated Enrollment: 1280
Study Start Date: January 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard SBP Reduction Arm

Nicardipine hydrochloride will be used PRN as primary agent in lowering SBP.

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

Drug: Nicardipine hydrochloride
IV nicardipine will be initiated at a rate of 5 mg/hr and increased by 2.5 mg/hr increments will continue every 15 min until the target SBP or maximum dose of 15 mg/hr is reached. If SBP is > target SBP despite infusion of the maximum nicardipine dose for 30 min, a second agent can be used (Labetalol 5-20 mg IV bolus every 15 min) for another h.
Other Name: Cardene® I.V.
Active Comparator: Intensive SBP Reduction Arm

Nicardipine hydrochloride will be used PRN as primary agent in lowering SBP.

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

Drug: Nicardipine hydrochloride
IV nicardipine will be initiated at a rate of 5 mg/hr and increased by 2.5 mg/hr increments will continue every 15 min until the target SBP or maximum dose of 15 mg/hr is reached. If SBP is > target SBP despite infusion of the maximum nicardipine dose for 30 min, a second agent can be used (Labetalol 5-20 mg IV bolus every 15 min) for another h.
Other Name: Cardene® I.V.

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 our current pilot trials are accurate.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

    • Note: Patients with SBP < 180mmHg 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 50,000mm3
  • 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
  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

Contacts
Contact: Adnan I Qureshi, MD 612-626-8221 qureshai@gmail.com
Contact: Kathryn A France, PHN 763-229-3821 kafrance@umn.edu

  Hide Study Locations
Locations
United States, Alabama
UAB Comprehensive Stroke Center Recruiting
Birmingham, Alabama, United States, 35249
University of South Alabama Withdrawn
Mobile, Alabama, United States, 36617
United States, Arizona
Maricopa Medical Center Not yet recruiting
Phoenix, Arizona, United States, 85008
Mayo Clinic Pheonix Not yet recruiting
Scottsdale, Arizona, United States, 85259
University of Arizona Medical Center - South Campus Recruiting
Tuscon, Arizona, United States, 85713
University of Arizona Medical Center - University Campus Recruiting
Tuscon, Arizona, United States, 85724
United States, California
Mercy San Juan Medical Center Withdrawn
Carmichael, California, United States, 95608
Community Regional Medical Center of Fresno Not yet recruiting
Fresno, California, United States, 93721
University of California San Diego Recruiting
La Jolla, California, United States, 92093
Long Beach Memorial Medical Center Not yet recruiting
Long Beach, California, United States, 90806
Ronald Regan UCLA Medical Center Not yet recruiting
Los Angeles, California, United States, 90095-9574
Hoag Memorial Hospital Presbyterian Completed
Newport Beach, California, United States, 92658
Stanford University Recruiting
Palo Alto, California, United States, 94304
Sutter Roseville Medical Center Suspended
Roseville, California, United States, 95661
UC Davis Medical Center Not yet recruiting
Sacramento, California, United States, 95817
Sutter Medical Center, Sacramento Withdrawn
Sacramento, California, United States, 95816
Mercy General Hospital Withdrawn
Sacramento, California, United States, 95815
UCSF Medical Center Recruiting
San Francisco, California, United States, 94143
Good Samaritan Hospital Not yet recruiting
San Jose, California, United States, 95124
Regional Medical Center of San Jose Withdrawn
San Jose, California, United States, 95116
Santa Clara Valley Medical Center Recruiting
Santa Clara, California, United States, 95138
United States, Colorado
Colorado Neurological Institute Recruiting
Englewood, Colorado, United States, 80113
United States, Connecticut
Yale - New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
United States, Delaware
Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
United States, Florida
University of Florida Gainesville Recruiting
Gainesville, Florida, United States, 32611
Baptist Medical Center Jacksonville Not yet recruiting
Jacksonville, Florida, United States, 32207
Mayo Clinic - Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
University of South Florida, Tampa General Hospital Recruiting
Tampa, Florida, United States, 33612
United States, Georgia
Grady Memorial Hospital Recruiting
Atlanta, Georgia, United States, 30303
Emory University Hospital Midtown Not yet recruiting
Atlanta, Georgia, United States, 30308
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
St. Joseph's Candler Health System Withdrawn
Savannah, Georgia, United States, 31405
United States, Idaho
Eastern Idaho Medical Consultants Completed
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Northwestern Memorial Hospital Withdrawn
Chicago, Illinois, United States, 60611
Rush University Medical Center Withdrawn
Chicago, Illinois, United States, 60612
Loyola University Medical Center Not yet recruiting
Maywood, Illinois, United States, 60153
Advocate Christ Medical Center Recruiting
Oak Lawn, Illinois, United States, 60453
OSF Saint Francis Medical Center Not yet recruiting
Peoria, Illinois, United States, 61637
St. John's Hospital Withdrawn
Springfield, Illinois, United States, 62769
Southern Illinois University Memorial Medical Center Not yet recruiting
Springfield, Illinois, United States, 62794-9643
United States, Indiana
Lutheran Hospital Indiana Not yet recruiting
Fort Wayne, Indiana, United States, 46804
Parkview Hospital Terminated
Fort Wayne, Indiana, United States, 46805
United States, Kansas
Kansas University Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Via Christi Hospital St. Francis Withdrawn
Wichita, Kansas, United States, 67214
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536-0296
University of Louisville Completed
Louisville, Kentucky, United States, 40292
United States, Louisiana
West Jefferson Medical Center Not yet recruiting
Marrero, Louisiana, United States, 70072
Interim LSU Hospital Not yet recruiting
New Orleans, Louisiana, United States, 70112
Tulane Medical Center Recruiting
New Orleans, Louisiana, United States, 70112
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Louisiana State University Health Sciences Center, Shreveport Not yet recruiting
Shreveport, Louisiana, United States, 71103
United States, Maine
Maine Medical Center Recruiting
South Portland, Maine, United States, 04106
United States, Massachusetts
Boston Medical Center Completed
Boston, Massachusetts, United States, 02118
Brigham & Women's Hospital Suspended
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Tufts Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02111
United States, Michigan
Wayne State University - Detroit Receiving Hospital Recruiting
Detroit, Michigan, United States, 48201
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Sinai-Grace Hospital Recruiting
Detroit, Michigan, United States, 48235
Allegiance Health Not yet recruiting
Jackson, Michigan, United States, 49201
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Essentia Health St. Mary's Medical Center Recruiting
Duluth, Minnesota, United States, 55805
Fairview Southdale Hospital Recruiting
Edina, Minnesota, United States, 55435
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55404
University of Minnesota Medical Center-Fairview Withdrawn
Minneapolis, Minnesota, United States, 55455
University of Minnesota Medical School Active, not recruiting
Minneapolis, Minnesota, United States, 55455
St. Cloud Hospital Recruiting
St. Cloud, Minnesota, United States, 56303
Regions Hospital Recruiting
St.Paul, Minnesota, United States, 55101
United States, Mississippi
University of Mississippi Medical Center Suspended
Jackson, Mississippi, United States, 39216
United States, Missouri
Research Medical Center Suspended
Kansas City, Missouri, United States, 64132
Saint Luke's Neuroscience Institute Completed
Kansas City, Missouri, United States, 64111
Saint Louis University Completed
Saint Louis, Missouri, United States, 63104
Mercy Hospital St. Louis Withdrawn
St. Louis, Missouri, United States, 63141
United States, New Jersey
Cooper University Hospital Recruiting
Camden, New Jersey, United States, 08103
St. Joseph's Regional Medical Center Suspended
Clifton, New Jersey, United States, 07012
New Jersey Neuroscience Institute, JFK Medical Center Suspended
Edison, New Jersey, United States, 08818
Hackensack University Medical Center Not yet recruiting
Hackensack, New Jersey, United States, 07601
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
United States, New York
Albany Medical College Withdrawn
Albany, New York, United States, 12208
Long Island College Hospital Withdrawn
Brooklyn, New York, United States, 11021
Mamoides Medical Center Not yet recruiting
Brooklyn, New York, United States, 11219
New York City Health and Hospitals Corp. / Kings County Hospital Recruiting
Brooklyn, New York, United States, 11203
Sister of Charity/Buffalo Mercy Hospital, Catholic Health System Not yet recruiting
Buffalo, New York, United States, 14214
UHS Wilson Medical Center Recruiting
Johnson City, New York, United States, 13790
North Shore University Hospital Not yet recruiting
Manhasset, New York, United States, 11030
Columbia University Recruiting
New York, New York, United States, 10032
Lincoln Medical and Mental Health Center Not yet recruiting
New York, New York, United States, 10451
SUNY Downstate Recruiting
New York, New York, United States, 10029
Rochester General Hospital Not yet recruiting
Rochester, New York, United States, 14621
Strong Stroke Center Not yet recruiting
Rochester, New York, United States, 14642
United States, North Carolina
Mission Hospital Recruiting
Asheville, North Carolina, United States, 28801-4601
Guilford Neurologic Associates Recruiting
Greenboro, North Carolina, United States, 27405
Vidant Medical Center Recruiting
Greenville, North Carolina, United States, 27834
Novant Clinical Research Institute/Forsyth Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27103
Wake Forest Baptist Medical Center (Wake Forest School of Medicine) Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Akron General Hospital Recruiting
Akron, Ohio, United States, 44307
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Ohio State University - Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
University of Toledo Medical Center Not yet recruiting
Toledo, Ohio, United States, 43614
United States, Oklahoma
Oklahoma University Health Sciences Center (OUHSC) Completed
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Providence Brain and Spine Institute Completed
Portland, Oregon, United States, 97225
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Lehigh Valley Health Network Completed
Allentown, Pennsylvania, United States, 18103
St. Luke's Hospital Bethlehem Withdrawn
Bethlehem, Pennsylvania, United States, 18015
Geisinger Medical Center Not yet recruiting
Danville, Pennsylvania, United States, 17822
Penn State Univ/ Hershey Med Center Recruiting
Hershey, Pennsylvania, United States, 17033
Hahnemann University Hospital Not yet recruiting
Philadelphia, Pennsylvania, United States, 19102
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19140
Thomas Jefferson University Not yet recruiting
Philadelphia, Pennsylvania, United States, 19107
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
UPMC-Mercy Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15219
UPMC Presbyterian Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Wellspan York Hospital Recruiting
York, Pennsylvania, United States, 17403
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina (Clinical SIte) Not yet recruiting
Charleston, South Carolina, United States, 29425
Palmetto Health Recruiting
Columbia, South Carolina, United States, 29203
United States, Tennessee
Erlanger Health System Withdrawn
Chattanooga, Tennessee, United States, 37403
Vanderbilt Stroke Center Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
St. David's Medical Center Not yet recruiting
Austin, Texas, United States, 78705
University Medical Center Brackenridge Recruiting
Austin, Texas, United States, 78705
Seton Medical Center Austin Recruiting
Austin, Texas, United States, 78705
UT Southwestern - Parkland Hospital Not yet recruiting
Dallas, Texas, United States, 75235
UT Southwestern University Hospital - Zale Lipshy, Dallas, TX Withdrawn
Dallas, Texas, United States, 75390
William P. Clements, Jr. University Hospital Withdrawn
Dallas, Texas, United States, 75390
Texas Tech University Health Sciences Center Recruiting
El Paso, Texas, United States, 79430
Valley Baptist Medical Center Recruiting
Harlingen, Texas, United States, 78550
Methodist Hospital - The Neurological Institute Not yet recruiting
Houston, Texas, United States, 77030
Baylor College of Medicine - St. Luke's Episcopal Hospital Recruiting
Houston, Texas, United States, 77030
Memorial Herman - Texas Medical Center Recruiting
Houston, Texas, United States, 77024
Baylor College of Medicine - Ben Taub Community Hospital Recruiting
Houston, Texas, United States, 77030
University of Texas Health Science Center at San Antonio Not yet recruiting
San Antonio, Texas, United States, 78229
United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84107
United States, Virginia
University of Virginia Withdrawn
Charlottesville, Virginia, United States, 22908
Virginia Commonwealth University Medical Center Recruiting
Richmond, Virginia, United States, 23298-0631
United States, West Virginia
West Virginia University - Ruby Memorial Hospital Not yet recruiting
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwakee, Wisconsin, United States, 53226
Aurora St. Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Canada, Alberta
University of Alberta Not yet recruiting
Edmonton, Alberta, Canada, 2E3.27WMC
Canada, Quebec
Montreal Neurological Institute and Hospital Not yet recruiting
Montreal, Quebec, Canada, H3A 2B4
China, Hebei
The Second Hospital of Hebei Medical University Not yet recruiting
Shijiazhuang City, Hebei, China, 050000
The Affiliated Hospital of Hebei United University Not yet recruiting
Tangshan, Hebei, China, 063000
China, Liaoning
The First Affiliated Hospital of Liaoning Medical College Withdrawn
Jinzhou, Liaoning, China, 121001
China, Shanxi
The Second Hospital of Shanxi Medical University Not yet recruiting
Taiyuan City, Shanxi, China, 030001
China
Baotou Central Hospital Suspended
Baotou, China
Beijing Tiantan Hospital Recruiting
Beijing, China, 100050
Peking University Third Hospital Not yet recruiting
Beijing, China, 100191
People's Hospital of Daxing Not yet recruiting
Beijing, China, 102600
Datong Third People's Hospital Recruiting
Datong, China
The First Hospital of Shanxi Medical University Not yet recruiting
Taiyuan City, China, 030001
The First People's Hospital of Taizhou Recruiting
Taizhou City, China, 318020
Tianjin Fourth Central Hospital Not yet recruiting
Tianjin, China, 300140
Renmin Hospital of Wuhan University Not yet recruiting
Wuhan, China, 430060
Tongji Medical College - Union Hospital Suspended
Wuhan, China
Wuhan Brain Hospital Recruiting
Wuhan, China, 430019
People's Hopital of Zhengzhou Not yet recruiting
Zhengzhou, China, 450003
Germany
Charité Universtity Medicine Berlin Recruiting
Berlin, Germany, 12203
University of Bonn Recruiting
Bonn, Germany, 53105
University Hospital Dresden Recruiting
Dresden, Germany, 01307
Clinic Frankfurt Hoechst Recruiting
Frankfurt, Germany, 65929
University Hospital Halle Recruiting
Halle (Saale), Germany, 06120
University Hospital Heidelberg Recruiting
Heidelberg, Germany, 69120
University Hospital Leipzig Recruiting
Leipzig, Germany, 04103
University Hospital Mannheim Recruiting
Mannheim, Germany, 68167
University Hospital Meunster Not yet recruiting
Munster, Germany, 48129
University of Tubingen Recruiting
Tubingen, Germany, 72076
Horst Schmidt Clinic Withdrawn
Wiesbaden, Germany, 65199
Japan
Nagoya Medical Center Recruiting
Nagoya City, Aichi, Japan, 460-0001
Nakamura Memorial Hospital Recruiting
Sapporo, Hokkaido, Japan, 060-8570
Saiseikai Yokohamashi Tobu Hospital Withdrawn
Kanagawa, Kanagowa, Japan, 230-8765
Saiseikai Kumamoto Hospital Not yet recruiting
Kumamoto City, Kumamoto, Japan, 861-4193
Kyushu Medical Center Recruiting
Fukuoka, Japan, 810-8563
Gifu University Hospital Recruiting
Gifu, Japan, 501-1194
Kagoshima Medical Center Withdrawn
Kagoshima, Japan, 892-0853
St. Marianna - Toyoko Recruiting
Kawasaki, Japan, 211-0063
St. Marianna University Hospital Recruiting
Kawasaki, Japan, 216-8511
Kobe City Medical Center General Hospital Recruiting
Kobe City, Japan
Kawasaki Medical School Completed
Okayama, Japan, 701-0192
National Cerebral and Cardiovascular Center Recruiting
Osaka, Japan, 565-8565
Kohnan Hospital Recruiting
Sendai, Japan
Kyorin University Recruiting
Tokyo, Japan
Saiseikai Central Hospital - Tokyo Recruiting
Tokyo, Japan, 108-0073
Toranomon Hospital Recruiting
Tokyo, Japan, 105-8470
Keio University Hospital Recruiting
Tokyo, Japan, 160-8582
Korea, Republic of
Hallym University Sacred Heart Hospital Withdrawn
Anyang, Gyeonggi, Korea, Republic of, 431070
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyeonggi, Korea, Republic of
Inje University Pusan Paik Hospital Withdrawn
Busan, Korea, Republic of
Chonnam National University Hospital Not yet recruiting
Gwangju, Korea, Republic of, 501-757
Seoul National University Boramae Hospital Not yet recruiting
Seoul, Korea, Republic of, 156-707
Kyung Hee University Hospital Not yet recruiting
Seoul, Korea, Republic of, 130-702
Asan Medical Center Withdrawn
Seoul, Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Taiwan
China Medical University Beigang Hospital Withdrawn
Beigang, Taiwan
Changhua Christian Hospital Recruiting
Changhua, Taiwan
Kaohsiung Medical University Hospital Not yet recruiting
Kaohsiung, Taiwan, 807
Kaohsiung Veterans General Hospital Recruiting
Kaohsiung City, Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 404
Taichung Veterans General Hopital Not yet recruiting
Taichung City, Taiwan, 407
Chi-Mei Medical Center Withdrawn
Tainan, Taiwan, 710
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan
Tri-Service General Hospital Recruiting
Taipei, Taiwan, 114
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Shin-Kong Wu Ho-Su Memorial Hospital Recruiting
Taipei, Taiwan, 111
Taipei Medical University - Wan Fang Hospital Not yet recruiting
Taipei, Taiwan
Taipei Veteran's Hospital Recruiting
Taipei, Taiwan
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Medical University of South Carolina
Johns Hopkins University
University of Michigan
Investigators
Study Director: Yuko Y Palesch, Ph.D. Medical University of South Carolina
Principal Investigator: Adnan I Qureshi, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

Publications:

Additional 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, 1U01NS062091-01, U01NS061861
Study First Received: August 4, 2010
Last Updated: April 22, 2015
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 26, 2015