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Intracerebral HemorrhagePhase 3ATACH-IINCT01176565

Antihypertensive Treatment of Acute Cerebral Hemorrhage-II

A Phase 3 study testing Intravenous nicardipine hydrochloride in people with Intracerebral Hemorrhage, run by University of Minnesota at 171 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intracerebral Hemorrhage
What is being tested?
Intravenous nicardipine hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
171 sitesin 7 countries
Study dates
15 May 2011to 8 Mar 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

171 sites in 7 countries.

171 sites in 7 countries

United States116 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Akron General Hospital

    Akron, Ohio, 44307

  • University of New Mexico

    Albuquerque, New Mexico, 87131

  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18103

  • Mission Hospital

    Asheville, North Carolina, 28801-4601

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Seton Medical Center Austin

    Austin, Texas, 78705

  • St. David's Medical Center

    Austin, Texas, 78705

  • University Medical Center Brackenridge

    Austin, Texas, 78705

  • UAB Comprehensive Stroke Center

    Birmingham, Alabama, 35249

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • New York City Health and Hospitals Corp. / Kings County Hospital

    Brooklyn, New York, 11203

  • Mamoides Medical Center

    Brooklyn, New York, 11219

  • Sister of Charity/Buffalo Mercy Hospital, Catholic Health System

    Buffalo, New York, 14214

  • Cooper University Hospital

    Camden, New Jersey, 08103

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • St. Joseph's Regional Medical Center

    Clifton, New Jersey, 07012

  • Palmetto Health

    Columbia, South Carolina, 29203

  • Ohio State University - Wexner Medical Center

    Columbus, Ohio, 43210

  • UT Southwestern - Parkland Hospital

    Dallas, Texas, 75235

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Wayne State University - Detroit Receiving Hospital

    Detroit, Michigan, 48201

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Sinai-Grace Hospital

    Detroit, Michigan, 48235

  • Essentia Health St. Mary's Medical Center

    Duluth, Minnesota, 55805

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • New Jersey Neuroscience Institute, JFK Medical Center

    Edison, New Jersey, 08818

  • Texas Tech University Health Sciences Center

    El Paso, Texas, 79430

  • Colorado Neurological Institute

    Englewood, Colorado, 80113

  • Lutheran Hospital Indiana

    Fort Wayne, Indiana, 46804

  • Parkview Hospital

    Fort Wayne, Indiana, 46805

  • Community Regional Medical Center of Fresno

    Fresno, California, 93721

  • University of Florida Gainesville

    Gainesville, Florida, 32611

  • Guilford Neurologic Associates

    Greenboro, North Carolina, 27405

  • Vidant Medical Center

    Greenville, North Carolina, 27834

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Valley Baptist Medical Center

    Harlingen, Texas, 78550

  • Penn State Univ/ Hershey Med Center

    Hershey, Pennsylvania, 17033

  • Memorial Herman - Texas Medical Center

    Houston, Texas, 77024

  • Baylor College of Medicine - Ben Taub Community Hospital

    Houston, Texas, 77030

  • Baylor College of Medicine - St. Luke's Episcopal Hospital

    Houston, Texas, 77030

  • Methodist Hospital - The Neurological Institute

    Houston, Texas, 77030

  • Eastern Idaho Medical Consultants

    Idaho Falls, Idaho, 83404

  • Allegiance Health

    Jackson, Michigan, 49201

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Baptist Medical Center Jacksonville

    Jacksonville, Florida, 32207

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • UHS Wilson Medical Center

    Johnson City, New York, 13790

  • Kansas University Medical Center

    Kansas City, Kansas, 66160

  • Saint Luke's Neuroscience Institute

    Kansas City, Missouri, 64111

  • Research Medical Center

    Kansas City, Missouri, 64132

  • University of California San Diego

    La Jolla, California, 92093

  • University of Kentucky

    Lexington, Kentucky, 40536-0296

  • Long Beach Memorial Medical Center

    Long Beach, California, 90806

  • Ronald Regan UCLA Medical Center

    Los Angeles, California, 90095-9574

  • University of Louisville

    Louisville, Kentucky, 40292

  • North Shore University Hospital

    Manhasset, New York, 11030

  • West Jefferson Medical Center

    Marrero, Louisiana, 70072

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Medical College of Wisconsin

    Milwakee, Wisconsin, 53226

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55404

  • West Virginia University - Ruby Memorial Hospital

    Morgantown, West Virginia, 26506

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Vanderbilt Stroke Center

    Nashville, Tennessee, 37232

  • Yale - New Haven Hospital

    New Haven, Connecticut, 06510

  • Interim LSU Hospital

    New Orleans, Louisiana, 70112

  • Tulane Medical Center

    New Orleans, Louisiana, 70112

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • SUNY Downstate

    New York, New York, 10029

  • Columbia University

    New York, New York, 10032

  • Lincoln Medical and Mental Health Center

    New York, New York, 10451

  • Christiana Hospital

    Newark, Delaware, 19718

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92658

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453

  • Oklahoma University Health Sciences Center (OUHSC)

    Oklahoma City, Oklahoma, 73104

  • Stanford University

    Palo Alto, California, 94304

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Hahnemann University Hospital

    Philadelphia, Pennsylvania, 19102

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Temple University

    Philadelphia, Pennsylvania, 19140

  • Maricopa Medical Center

    Phoenix, Arizona, 85008

  • UPMC Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15213

  • UPMC-Mercy Hospital

    Pittsburgh, Pennsylvania, 15219

  • Providence Brain and Spine Institute

    Portland, Oregon, 97225

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Virginia Commonwealth University Medical Center

    Richmond, Virginia, 23298-0631

  • Rochester General Hospital

    Rochester, New York, 14621

  • Strong Stroke Center

    Rochester, New York, 14642

  • Sutter Roseville Medical Center

    Roseville, California, 95661

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • UC Davis Medical Center

    Sacramento, California, 95817

  • St. Cloud Hospital

    Saint Cloud, Minnesota, 56303

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • UCSF Medical Center

    San Francisco, California, 94143

  • Good Samaritan Hospital

    San Jose, California, 95124

  • Santa Clara Valley Medical Center

    Santa Clara, California, 95138

  • Mayo Clinic Pheonix

    Scottsdale, Arizona, 85259

  • Louisiana State University Health Sciences Center, Shreveport

    Shreveport, Louisiana, 71103

  • Maine Medical Center

    South Portland, Maine, 04106

  • Southern Illinois University Memorial Medical Center

    Springfield, Illinois, 62794-9643

  • Saint Louis University

    St Louis, Missouri, 63104

  • University of South Florida, Tampa General Hospital

    Tampa, Florida, 33612

  • University of Toledo Medical Center

    Toledo, Ohio, 43614

  • Banner University Medical Center - South Campus

    Tuscon, Arizona, 85713

  • Banner University Medical Center - University Campus

    Tuscon, Arizona, 85724

  • Reading Hospital

    West Reading, Pennsylvania, 19611

  • Novant Clinical Research Institute/Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

  • Wake Forest Baptist Medical Center (Wake Forest School of Medicine)

    Winston-Salem, North Carolina, 27157

  • Wellspan York Hospital

    York, Pennsylvania, 17403

Other trials in United States

Japan16 sites

  • Kyushu Medical Center

    Fukuoka, 810-8563

  • Gifu University Hospital

    Gifu, 501-1194

  • Saiseikai Yokohamashi Tobu Hospital

    Kanagawa, Kanagowa, 230-8765

  • St. Marianna - Toyoko

    Kawasaki, 211-0063

  • St. Marianna University Hospital

    Kawasaki, 216-8511

  • Kobe City Medical Center General Hospital

    Kobe

  • Saiseikai Kumamoto Hospital

    Kumamoto, Kumamoto, 861-4193

  • Nagoya Medical Center

    Nagoya, Aichi-ken, 460-0001

  • Kawasaki Medical School

    Okayama, 701-0192

  • National Cerebral and Cardiovascular Center

    Osaka, 565-8565

  • Nakamura Memorial Hospital

    Sapporo, Hokkaido, 060-8570

  • Kohnan Hospital

    Sendai

  • Toranomon Hospital

    Tokyo, 105-8470

  • Saiseikai Central Hospital - Tokyo

    Tokyo, 108-0073

  • Keio University Hospital

    Tokyo, 160-8582

  • Kyorin University

    Tokyo

Other trials in Japan

China12 sites

  • Baotou Central Hospital

    Baotou

  • Beijing Tiantan Hospital

    Beijing, 100050

  • Peking University Third Hospital

    Beijing, 100191

  • Datong Third People's Hospital

    Datong

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

  • The Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

  • The First Hospital of Shanxi Medical University

    Taiyuan, 030001

  • The First People's Hospital of Taizhou

    Taizhou, 318020

  • Tianjin Fourth Central Hospital

    Tianjin, 300140

  • Wuhan Brain Hospital

    Wuhan, 430019

  • Renmin Hospital of Wuhan University

    Wuhan, 430060

  • People's Hopital of Zhengzhou

    Zhengzhou, 450003

Other trials in China

Germany10 sites

  • Charité Universtity Medicine Berlin

    Berlin, 12203

  • University of Bonn

    Bonn, 53105

  • University Hospital Dresden

    Dresden, 01307

  • Clinic Frankfurt Hoechst

    Frankfurt, 65929

  • University Hospital Halle

    Halle, 06120

  • University Hospital Heidelberg

    Heidelberg, 69120

  • University Hospital Leipzig

    Leipzig, 04103

  • University Hospital Mannheim

    Mannheim, 68167

  • University Hospital Meunster

    Münster, 48129

  • University of Tubingen

    Tübingen, 72076

Other trials in Germany

Taiwan10 sites

  • Changhua Christian Hospital

    Changhua

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 807

  • Kaohsiung Veterans General Hospital

    Kaohsiung City

  • China Medical University Hospital

    Taichung, 404

  • Taichung Veterans General Hopital

    Taichung, 407

  • National Cheng Kung University Hospital

    Tainan

  • National Taiwan University Hospital

    Taipei, 100

  • Shin-Kong Wu Ho-Su Memorial Hospital

    Taipei, 111

  • Tri-Service General Hospital

    Taipei, 114

  • Taipei Veteran's Hospital

    Taipei

Other trials in Taiwan

South Korea5 sites

  • Chonnam National University Hospital

    Gwangju, 501-757

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do

  • Seoul National University Hospital

    Seoul, 110-744

  • Kyung Hee University Hospital

    Seoul, 130-702

  • Seoul National University Boramae Hospital

    Seoul, 156-707

Other trials in South Korea

Canada2 sites

  • University of Alberta

    Edmonton, Alberta, 2E3.27WMC

  • Montreal Neurological Institute and Hospital

    Montreal, Quebec, H3A 2B4

Other trials in Canada

About this study

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

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.
Read the 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.

Being tested
Intravenous nicardipine hydrochloride
Keywords
Acute hypertensive response, intracerebral hemorrhage, blood pressure, outcome, nicardipine
Medical subject headings
Cerebral Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravenous nicardipine hydrochlorideDrug

    Also called Cardene® I.V., Nicardipine HCl injection, nicardipine hydrochloride injection, nicardipine IV

    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.

Study groups in NCT01176565
Study groupRoleWhat they receive
Standard SBP Reduction ArmActive comparatorIntravenous 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.
Receives: Drug: Intravenous nicardipine hydrochloride
Intensive SBP Reduction ArmActive comparatorIntravenous 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.
Receives: Drug: Intravenous nicardipine hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Death or Disability According to Modified Rankin Scale Score at 90 Days (3 Months) 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.

    Measured: 90 days (± 14 days per protocol window; up to ± 30 days data is used) from randomization

Secondary outcomes (2)

  1. 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

    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.

    Measured: 90 days (± 14 days per protocol window; up to ± 30 days data is used) from randomization

  2. 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.)

    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.

    Measured: From the baseline head CT to the 24 +/- 6 hours from randomization head CT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2010 (estimated)
  2. Study start15 May 2011
  3. Primary completion21 Dec 2015
  4. Study completion8 Mar 2016

Why it stopped: Planned interim analysis: no significant outcome differences between groups

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
1,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01176565
Sponsor's protocol ID
1207M17921
Other IDs
U01NS062091, U01NS061861, U01NS059041, U01NS056975, H23-4-3
Acronym
ATACH-II
Status last verified
Mar 2017
First submitted
4 Aug 2010
Last updated
25 Apr 2017
Data monitoring committee
Yes
Individual data sharing
Yes: 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.

Publications

  • Qureshi AI, Palesch YY, Martin R, Novitzke J, Cruz-Flores S, Ehtisham A, Ezzeddine MA, Goldstein JN, Hussein HM, Suri MF, Tariq N; Antihypertensive Treatment of Acute Cerebral Hemorrhage Study Investigators. Effect of systolic blood pressure reduction on hematoma expansion, perihematomal edema, and 3-month outcome among patients with intracerebral hemorrhage: results from the antihypertensive treatment of acute cerebral hemorrhage study. Arch Neurol. 2010 May;67(5):570-6. doi: 10.1001/archneurol.2010.61.

    PubMed 20457956

  • Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH) investigators. Antihypertensive treatment of acute cerebral hemorrhage. Crit Care Med. 2010 Feb;38(2):637-48. doi: 10.1097/CCM.0b013e3181b9e1a5.

    PubMed 19770736

  • Qureshi AI. Acute hypertensive response in patients with stroke: pathophysiology and management. Circulation. 2008 Jul 8;118(2):176-87. doi: 10.1161/CIRCULATIONAHA.107.723874. No abstract available.

    PubMed 18606927

  • Qureshi AI. Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH): rationale and design. Neurocrit Care. 2007;6(1):56-66. doi: 10.1385/ncc:6:1:56.

    PubMed 17356194

  • Qureshi AI, Palesch YY. Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH) II: design, methods, and rationale. Neurocrit Care. 2011 Dec;15(3):559-76. doi: 10.1007/s12028-011-9538-3.

    PubMed 21626077

  • Qureshi AI, Palesch YY, Martin R, Novitzke J, Cruz Flores S, Ehtisham A, Goldstein JN, Kirmani JF, Hussein HM, Suri MF, Tariq N; Antihypertensive Treatment of Acute Cerebral Hemorrhage Investigators. Systolic blood pressure reduction and risk of acute renal injury in patients with intracerebral hemorrhage. Am J Med. 2012 Jul;125(7):718.e1-6. doi: 10.1016/j.amjmed.2011.09.031. Epub 2012 May 4.

    PubMed 22560810

  • Qureshi AI, Palesch YY, Martin R, Toyoda K, Yamamoto H, Wang Y, Wang Y, Hsu CY, Yoon BW, Steiner T, Butcher K, Hanley DF, Suarez JI. Interpretation and Implementation of Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT II). J Vasc Interv Neurol. 2014 Jun;7(2):34-40. No abstract available.

    PubMed 25132910

  • Qureshi AI, Palesch YY, Barsan WG, Hanley DF, Hsu CY, Martin RL, Moy CS, Silbergleit R, Steiner T, Suarez JI, Toyoda K, Wang Y, Yamamoto H, Yoon BW; ATACH-2 Trial Investigators and the Neurological Emergency Treatment Trials Network. Intensive Blood-Pressure Lowering in Patients with Acute Cerebral Hemorrhage. N Engl J Med. 2016 Sep 15;375(11):1033-43. doi: 10.1056/NEJMoa1603460. Epub 2016 Jun 8.

    PubMed 27276234

  • Patel NM, Karamchandani RR, Jaffa MN, Wang L, Yang H, Cadena R, Swisher C, Bernard JD, Parish JM, Stetler WR, Magun R, Taylor A, Woo D, Qureshi A, Asimos AW, Morris NA. Association of Hemispheric Laterality With Neurosurgical Intervention in Intracerebral Hemorrhage: A Posthoc Bayesian Analysis of ATACH-2 and ERICH. Stroke. 2026 Oct 22. doi: 10.1161/STROKEAHA.125.055017. Online ahead of print.

    PubMed 42910414

  • Ren X, Chen X, Hu X, Lin Y, Chen C, Wang J, Robinson TG, Liu L, Venturelli PM, Martins SC, Pontes-Neto OM, Qureshi AI, Song L, Anderson C, Wang X; as the INTERACT and ATACH-II Investigators. Effects of Blood Pressure Lowering by Hematoma Location in Acute Intracerebral Hemorrhage. Neurology. 2026 Nov 10;107(9):e218514. doi: 10.1212/WNL.0000000000218514. Epub 2026 Oct 8.

    PubMed 42848972

  • Wang X, Phan TG, Ren X, Ma HH, Li Q, Ouyang M, Delcourt C, Chen X, Wang J, Robinson TG, Arima H, Ma L, Hu X, You C, Liu L, Venturelli PM, Martins SC, Pontes-Neto OM, Chalmers JP, Song L, Qureshi AI, Anderson C. Systolic Blood Pressure Trajectory and Outcomes in Acute Intracerebral Hemorrhage: Pooled Analysis of the 4 INTERACT and ATACH-II Clinical Trials. Neurology. 2026 Apr 14;106(7):e214671. doi: 10.1212/WNL.0000000000214671. Epub 2026 Mar 19.

    PubMed 41855454

  • Yu B, Melmed KR, Frontera J, Zhu W, Huang H, Qureshi AI, Maggard A, Steinhof M, Kuohn L, Kumar A, Berson ER, Tran AT, Payabvash S, Ironside N, Brush B, Dehkharghani S, Razavian N, Ranganath R. Predicting hematoma expansion after intracerebral hemorrhage: a comparison of clinician prediction with deep learning radiomics models. Neurocrit Care. 2025 Aug;43(1):119-129. doi: 10.1007/s12028-025-02214-3. Epub 2025 Feb 7.

    PubMed 39920546

  • Li Q, Lv X, Morotti A, Qureshi AI, Dowlatshahi D, Falcone GJ, Sheth KN, Shoamanesh A, Murthy SB, Viswanathan A, Goldstein JN. Optimal Magnitude of Blood Pressure Reduction and Hematoma Growth and Functional Outcomes in Intracerebral Hemorrhage. Neurology. 2025 Mar 11;104(5):e213412. doi: 10.1212/WNL.0000000000213412. Epub 2025 Feb 6.

    PubMed 39913881

  • Tsukita K, Sakamaki-Tsukita H, Kaiser S, Zhang L, Messa M, Serrano-Fernandez P, Takahashi R. High-Throughput CSF Proteomics and Machine Learning to Identify Proteomic Signatures for Parkinson Disease Development and Progression. Neurology. 2023 Oct 3;101(14):e1434-e1447. doi: 10.1212/WNL.0000000000207725. Epub 2023 Aug 16.

    PubMed 37586882

  • Qureshi AI, Huang W, Hanley DF, Hsu CY, Martin RH, Malhotra K, Steiner T, Suarez JI, Yamamoto H, Toyoda K. Early Hyperchloremia is Independently Associated with Death or Disability in Patients with Intracerebral Hemorrhage. Neurocrit Care. 2022 Oct;37(2):487-496. doi: 10.1007/s12028-022-01514-2. Epub 2022 May 5.

    PubMed 35513751

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Intravenous nicardipine hydrochloride in people with Intracerebral Hemorrhage, run by University of Minnesota at 171 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 171 sites in United States, Japan, China, Germany, Taiwan and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01176565, which also lists 36 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017.

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