Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH-II)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 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: June 19, 2014
Last verified: June 2014
  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, 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 GCS score (aggregate of verbal, eye, and motor response scores) of 5 or greater at time of ED arrival.
  • 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, AVM, or aneurysms.
  • Intracerebral hematoma considered to be related to trauma.
  • ICH located in infratentorial regions such as pons or cerebellum.
  • 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

  Hide Study Locations
Locations
United States, Alabama
UAB Comprehensive Stroke Center Recruiting
Birmingham, Alabama, United States, 35249
Contact: Andrei Alexandrov, MD       avalexandrov@att.net   
United States, California
Mercy San Juan Medical Center Withdrawn
Carmichael, California, United States, 95608
University of California San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Dawn Meyer, MD       dmmeyer@mail.ucsd.edu   
Hoag Memorial Hospital Presbyterian Recruiting
Newport Beach, California, United States, 92658
Contact: David Brown, MD       DMBrown@hoaghospital.org   
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Chitra Venkatasubramanian, MD       chitrav@stanford.edu   
Sutter Roseville Medical Center Recruiting
Roseville, California, United States, 95661
Contact: Asim Mahmood, MD       mahmooa@sutterhealth.org   
Mercy General Hospital Withdrawn
Sacramento, California, United States, 95815
Sutter Medical Center Withdrawn
Sacramento, California, United States, 95816
United States, Colorado
Colorado Neurological Institute Recruiting
Englewood, Colorado, United States, 80113
Contact: Ira Chang, MD       irachangmd@gmail.com   
United States, Connecticut
Yale - New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Contact: David Greer, MD       david.greer@yale.edu   
United States, Florida
Mayo Clinic - Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: David W Freeman, MD       freeman.william1@mayo.edu   
University of South Florida, Tampa General Hospital Recruiting
Tampa, Florida, United States, 33612
Contact: David Rose, MD       drose1@health.usf.edu   
United States, Georgia
Grady Memorial Hospital Recruiting
Atlanta, Georgia, United States, 30303
Contact: David Wright, MD       david.wright@emory.edu   
St. Joseph's Candler Health System Suspended
Savannah, Georgia, United States, 31405
United States, Idaho
Eastern Idaho Regional Medical Center Recruiting
Idaho Falls, Idaho, United States, 83404
Contact: Kenneth Krell, MD       kkrell1@gmail.com   
United States, Illinois
Rush University Medical Center Withdrawn
Chicago, Illinois, United States, 60612
St. John's Hospital Recruiting
Springfield, Illinois, United States, 62769
Contact: Fazeel Siddiqui, MD       fsiddiqui@siumed.edu   
United States, Indiana
Parkview Hospital Recruiting
Fort Wayne, Indiana, United States, 46805
Contact: Rakesh Khatri, MD       rkhatri@fwnc.com   
United States, Kansas
Kansas University Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Abhijit Lele, MD       alele@kumc.edu   
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40292
Contact: Kerri Remmel, MD       kerri.remmel@louisville.edu   
United States, Louisiana
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Arash Ashfinnik, MD       aafshinnik@ochsner.org   
United States, Maine
Maine Medical Center Recruiting
South Portland, Maine, United States, 04106
Contact: David Seder       sederd@mmc.org   
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Joshua Goldstein, MD       jgoldstein@partners.org   
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Joseph Burns, MD       Joseph.Burns@bmc.org   
Brigham & Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Sherry Chou, MD       schou1@partners.org   
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Christopher Lewandowski, MD       clewand1@hfhs.org   
Wayne State University - Detroit Receiving Hospital Recruiting
Detroit, Michigan, United States, 48201
Contact: Gregory Norris, MD       gnorris@med.wayne.edu   
Saint Louis University Suspended
Saint Louis, Michigan, United States, 63104
United States, Minnesota
Fairview Southdale Hospital Recruiting
Edina, Minnesota, United States, 55435
Contact: Alexander Zubkov, MD       zubkovmd@gmail.com   
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
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Thomas Bergman, MD       Thomas.Bergman@hcmed.org   
St. Cloud Hospital Recruiting
St. Cloud, Minnesota, United States, 56303
Contact: Fareed Suri, MD       surim@centracare.com   
Regions Hospital Recruiting
St.Paul, Minnesota, United States, 55101
Contact: Tenbit Emiru, MD       tenbit.x.emiru@healthpartners.com   
United States, Mississippi
University of Mississippi Medical Center Suspended
Jackson, Mississippi, United States, 39216
United States, Missouri
Research Medical Center Recruiting
Kansas City, Missouri, United States, 64132
Contact: Iftekhar Ahmed, MD       iftekhar.ahmed@hcahealthcare.com   
St. Luke's Neuroscience Institute Suspended
Kansas City, Missouri, United States, 64111
Mercy Hospital Suspended
St. Louis, Missouri, United States, 63141
United States, New Jersey
St. Joseph's Regional Medical Center Recruiting
Clifton, New Jersey, United States, 07012
Contact: Avery Katz       averylinda@optonline.net   
New Jersey Neuroscience Institute, JFK Medical Center Recruiting
Edison, New Jersey, United States, 08818
Contact: Jawad Kirmani, MD       Jkirmani@solarishs.org   
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Marc Malkoff, MD       mmalkoff@salud.unm.edu   
United States, New York
Albany Medical College Suspended
Albany, New York, United States, 12208
New York City Health and Hospitals Corp. / Kings County Hospital Recruiting
Brooklyn, New York, United States, 11203
Contact: Helen Valsamis, MD       helen.valsamis@downstate.edu   
UHS Wilson Medical Center Recruiting
Johnson City, New York, United States, 13790
Contact: Yahia Lodi, MD       lodiy@upstate.edu   
SUNY Downstate Recruiting
New York, New York, United States, 10029
Contact: Steven Levine, MD       steven.levine@downstate.edu   
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Stephan Mayer, MD       sam14@columbia.edu   
United States, North Carolina
Guilford Neurologic Associates Recruiting
Greenboro, North Carolina, United States, 27405
Contact: Pramod Sethi       psethi@guilfordneurologic.com   
Novant Clinical Research Institute/Forsyth Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Chere Monique Gregory, MD       cmchase@novanthealth.org   
Wake Forest School of Medicine Withdrawn
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Akron General Hospital Recruiting
Akron, Ohio, United States, 44307
Contact: James Gebel, MD       james.gebel@akrongeneral.org   
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Nicholas Bambakidis, MD       nicholas.bambakidis2@UHhospitals.org   
Ohio State University - Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Chad Miller, MD       ChadM.Miller@osumc.edu   
United States, Oklahoma
Oklahoma University Health Sciences Center (OUHSC) Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Akram Shhadeh, MD       Akram-shhadeh@ouhsc.edu   
United States, Oregon
Providence Brain and Spine Institute Suspended
Portland, Oregon, United States, 97225
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Qaisar Shah       qshah@amh.org   
Lehigh Valley Health Network Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Hermann Christian Schumacher, MD       Hermann_C.Schumacher@lvhn.org   
Penn State Univ/ Hershey Med Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: J. Christopher Zacko, MD       jzacko@hmc.psu.edu   
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Steven Messe, MD       steven.messe@uphs.upenn.edu   
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Nina Gentile, MD       ngentile@temple.edu   
UPMC Presbyterian Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Bradley Molyneaux, MD       molyneauxbj@upmc.edu   
United States, South Carolina
Palmetto Health Recruiting
Columbia, South Carolina, United States, 29203
Contact: Souvik Sen, MD       souvik.sen@uscmed.sc.edu   
United States, Tennessee
Vanderbilt Stroke Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Michael Froehler, MD       m.froehler@vanderbilt.edu   
United States, Texas
Valley Baptist Medical Center Recruiting
Harlingen, Texas, United States, 78550
Contact: Ameer Hassan, MD       ameer.hassan@valleybaptist.net   
Baylor College of Medicine - St. Luke's Episcopal Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Jose Suarez       jisuarez@bcm.tmc.edu   
Baylor College of Medicine - Ben Taub Community Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Paulina Sergot, MD       psergot@gmail.com   
Memorial Herman - Texas Medical Center Recruiting
Houston, Texas, United States, 77024
Contact: Tiffany Chang, MD       tiffany.r.chang@uth.tmc.edu   
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwakee, Wisconsin, United States, 53226
Contact: Ann Helms, MD       ahelms@mcw.edu   
China, Liaoning
The First Affiliated Hospital of Liaoning Medical College Suspended
Jinzhou, Liaoning, China, 121001
China
Baotou Central Hospital Suspended
Baotou, China
China Medical University Beigang Hospital Recruiting
Beigang, China
Contact: Chun-Lin Liu, MD       chunlin2539@gmail.com   
Beijing Tiantan Hospital Recruiting
Beijing, China, 100050
Contact: Yongjun Wang, MD       yong.junwang1962@gmail.com   
Datong Third People's Hospital Recruiting
Datong, China
Contact: Xudong Ren, MD       dtsyyrxd@163.com   
The First People's Hospital of Taizhou Recruiting
Taizhou City, China, 318020
Contact: Zhimin Wang, MD       welson1980@163.com   
Tongji Medical College - Union Hospital Recruiting
Wuhan, China
Contact: Bo Hu, MD       hubo@mail.hust.edu.cn   
Wuhan Brain Hospital Recruiting
Wuhan, China, 430019
Contact: Yuhua Chen, MD       whyuhuachen@163.com   
Germany
University Hospital Leipzig Recruiting
Leipzig, Germany, 04103
Contact: Carsten Hobohm, MD       carsten.hobohm@medizin.uni-leipzig.de   
Japan
Nagoya Medical Center Recruiting
Nagoya City, Aichi, Japan, 460-0001
Contact: Satoshi Okuda, MD       okudas@nnh.hosp.go.jp   
Nakamura Memorial Hospital Recruiting
Sapporo, Hokkaido, Japan, 060-8570
Contact: Kenji Kamiyama, MD       kenkami@med.nmh.or.jp   
Kyushu Medical Center Recruiting
Fukuoka, Japan, 810-8563
Contact: Yasushi Okada, MD       y-okada@kyumed.jp   
Gifu University Hospital Recruiting
Gifu, Japan, 501-1194
Contact: Shinichi Yoshimura, MD       s-yoshi@gifu-u.ac.jp   
Saiseikai Yokohamashi Tobu Hospital Recruiting
Kanagawa, Japan
Contact: Jun Gotoh, MD       j-gotoh@tobu.saiseikai.or.jp   
St. Marianna - Toyoko Recruiting
Kawasaki, Japan, 211-0063
Contact: Toshihiro Ueda, MD       toshiueda-nsu@umin.net   
St. Marianna University Hospital Recruiting
Kawasaki, Japan, 216-8511
Contact: Yasuhiro Hasegawa, MD       hasegawa-neuro1@marianna-u.ac.jp   
Kobe City Medical Center General Hospital Recruiting
Kobe City, Japan
Contact: Nobuyuki Sakai, MD       n.sakai@siren.ocn.ne.jp   
Kawasaki Medical School Recruiting
Okayama, Japan, 701-0192
Contact: Kazumi Kimura, MD       kimurak@med.kawasaki-m.ac.jp   
National Cerebral and Cardiovascular Center Recruiting
Osaka, Japan, 565-8565
Contact: Kazunori Toyoda       toyoda@hsp.ncvc.go.jp   
Kohnan Hospital Recruiting
Sendai, Japan
Contact: Eisuke Furui, MD       e-furui@kohnan-sendai.or.jp   
Kyorin University Recruiting
Tokyo, Japan
Contact: Yoshiaki Shiokawa, MD       shiokawa-kyr@umin.ac.jp   
Keio University Hospital Recruiting
Tokyo, Japan, 160-8582
Contact: Yoshiaki Itoh, MD       shiloh@z8.keio.jp   
Saiseikai Central Hospital - Tokyo Recruiting
Tokyo, Japan, 108-0073
Contact: Haruhiko Hoshino, MD       hhoshino-keio@umin.net   
Toranomon Hospital Recruiting
Tokyo, Japan, 105-8470
Contact: Takayuki Hara, MD       thara@toranomon.gr.jp   
Korea, Republic of
Hallym University Sacred Heart Hospital Recruiting
Anyang, Gyeonggi, Korea, Republic of, 431070
Contact: Byung-Chul Lee, MD       ssbrain@hallym.ac.kr   
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyeonggi, Korea, Republic of
Contact: Hee-Joon Bae, MD       braindoc@snu.ac.kr   
Inje University Pusan Paik Hospital Recruiting
Busan, Korea, Republic of
Contact: Eung-Gyu Kim, MD       kgstroke@korea.com   
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Byung-Woo Yoon, MD       bwyoon@snu.ac.kr   
Asan Medical Center Withdrawn
Seoul, Korea, Republic of
Taiwan
Changhua Christian Hospital Recruiting
Changhua, Taiwan
Contact: Mu-Chien Sun, MD       sunmc@yahoo.com   
Kaohsiung Veterans General Hospital Recruiting
Kaohsiung City, Taiwan
Contact: Yuk-Keung Lo       yklo@vghks.gov   
China Medical University Hospital Suspended
Taichung, Taiwan, 404
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan
Contact: Chih-Hung Chen, MD       ichih@mail.ncku.edu.tw   
Tri-Service General Hospital Recruiting
Taipei, Taiwan, 114
Contact: Hsin-I Ma, MD       uf004693@mail2000.com.tw   
Taipei Veterans Hospital Suspended
Taipei, Taiwan, 11217
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Jiann-Shing Jeng       jsjeng@ntu.edu.tw   
Shin-Kong Wu Ho-Su Memorial Hospital Recruiting
Taipei, Taiwan, 111
Contact: Li-Ming Lien, MD       M002177@ms.skh.org.tw   
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: h, 1U01NS062091-01, U01NS061861
Study First Received: August 4, 2010
Last Updated: June 19, 2014
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:
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
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on July 23, 2014