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

This study has been completed.
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
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: May 4, 2016
Last verified: May 2016
  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: 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:
  • A pragmatic, streamlined randomized design to evaluate the efficacy of intensive SBP reduction and its effect on outcomes measures at 24 h, 30 d and at 3 m from randomization in subjects with ICH [ Time Frame: August, 2010 through 3 + 1 months margin from final subject randomization ] [ 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 mis-classification and increase the sensitivity of detecting meaningful difference.


Secondary Outcome Measures:
  • Secondary outcomes [ Time Frame: August, 2010 through 3 + 1 months margin from final subject randomization ] [ 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).

  • Secondary Outcomes [ Time Frame: August, 2010 though 3 + 1 months margin from final hospital discharge of any subject enrolled. ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 1000
Study Start Date: January 2011
Study Completion Date: March 2016
Primary Completion Date: January 2016 (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

  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 - University Campus
Tuscon, Arizona, United States, 85724
Banner University Medical Center - South Campus
Tuscon, Arizona, United States, 85713
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
Boston Medical Center
Boston, Massachusetts, United States, 02118
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
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
University of Minnesota Medical School
Minneapolis, Minnesota, United States, 55455
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
Lincoln Medical and Mental Health Center
New York, New York, United States, 10451
Columbia University
New York, New York, United States, 10032
SUNY Downstate
New York, New York, United States, 10029
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
Medical University of South Carolina (Clinical SIte)
Charleston, South Carolina, United States, 29425
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
Methodist Hospital - The Neurological Institute
Houston, Texas, United States, 77030
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
Memorial Herman - Texas Medical Center
Houston, Texas, United States, 77024
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
Peking University Third Hospital
Beijing, China, 100191
Beijing Tiantan Hospital
Beijing, China, 100050
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 Medical University Hospital
Kaohsiung, Taiwan, 807
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
China Medical University Hospital
Taichung, Taiwan, 404
Taichung Veterans General Hopital
Taichung City, Taiwan, 407
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
Investigators
Principal Investigator: Adnan I Qureshi, MD University of Minnesota - Clinical and Translational Science Institute
Study Director: Yuko Y Palesch, PhD Medical University of South Carolina
  More Information

Additional Information:
Publications:

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  U01NS061861 
Study First Received: August 4, 2010
Last Updated: May 4, 2016
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
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on May 26, 2016