Study Stopped
Planned interim analysis: no significant outcome differences between groups
Antihypertensive Treatment of Acute Cerebral Hemorrhage-II
ATACH-II
6 other identifiers
interventional
1,000
7 countries
171
Brief 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.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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2011
Longer than P75 for phase_3
171 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2010
CompletedFirst Posted
Study publicly available on registry
August 6, 2010
CompletedStudy Start
First participant enrolled
May 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 8, 2016
CompletedResults Posted
Study results publicly available
April 25, 2017
CompletedApril 25, 2017
March 1, 2017
4.6 years
August 4, 2010
January 1, 2017
March 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
90 days (± 14 days per protocol window; up to ± 30 days data is used) from randomization
Secondary Outcomes (2)
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
90 days (± 14 days per protocol window; up to ± 30 days data is used) from randomization
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.)
From the baseline head CT to the 24 +/- 6 hours from randomization head CT
Other Outcomes (4)
Neurological Deterioration Within 24 Hours, Defined by a Decrease of 2 or More Points on the GCS Score or an Increase of 4 or More Points on the NIHSS Score From Baseline, Not Related to Sedation or Hypnotic-agent Use and Sustained for at Least 8 Hours.
From randomization through the 24-hour treatment period
Hypotension Within 72 Hours
From randomization through 72 hours from randomization
Treatment-related Serious Adverse Event Within 72 Hours of Randomization
From randomization through 72 hours (3 days)
- +1 more other outcomes
Study Arms (2)
Standard SBP Reduction Arm
ACTIVE 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.
Intensive SBP Reduction Arm
ACTIVE 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age 18 years or older
- IV nicardipine can be initiated within 4.5 hours of symptom onset.
- Clinical signs consistent with the diagnosis of stroke, including impairment of language, motor function, cognition, and/or gaze, vision, or neglect.
- Total Glasgow Coma Scale (GCS) score (aggregate of verbal, eye, and motor response scores) of 5 or greater at time of emergency department (ED) arrival.
- International normalized ratio (INR) value \< 1.5
- CT scan demonstrates intraparenchymal hematoma with manual hematoma volume measurement \<60 cc.
- For subjects randomized prior to IV antihypertensive administration: SBP greater than 180 mmHg\* prior to IV antihypertensive treatment (this includes pre-hospital treatment) AND WITHOUT spontaneous SBP reduction to below 180 mmHg at the time of randomization OR
- For subjects randomized after IV antihypertensive administration: SBP greater than 180 mmHg\* prior to IV antihypertensive treatment (this includes pre-hospital treatment) AND WITHOUT SBP reduction to below 140 mmHg at the time of randomization.
- Informed consent obtained by subject, legally authorized representative, or next of kin.
- Notes: The unit "mmHg" stands for "millimeters of mercury", a standard way of measuring blood pressure. Patients with SBP \< 180 mmHg should be monitored for 4.5 hours from symptom onset as their SBP may rise to eligible levels before the eligibility window closes.
You may not qualify if:
- ICH is due to previously known neoplasms, arteriovenous malformation (AVM), or aneurysms.
- Intracerebral hematoma considered to be related to trauma.
- ICH located in infratentorial regions such as pons or cerebellum.
- Intraventricular hemorrhage (IVH) associated with intraparenchymal hemorrhage and blood completely fills one lateral ventricle or more than half of both ventricles.
- Patient to receive immediate surgical evacuation.
- Current pregnancy, or parturition within previous 30 days, or active lactation.
- Use of dabigatran within the last 48 hours\*\*.
- A platelet count less than 50,000 per microliter (µL or mm3)
- Known sensitivity to nicardipine.
- Pre-morbid disability requiring assistance in ambulation or activities of daily living.
- Subject's living will precludes aggressive ICU management.
- Subject is currently participating in another interventional clinical trial
- Use of dabigatran was clarified through investigator presentations, educational materials, and clinical tools to include newer similar class medications (such as rivaroxaban, apixaban, and edoxaban) that were being developed and in various stages of approval across enrolling countries through the course of this trial, in the event that patients using these medications may have been encountered during screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Minnesotalead
- National Institute of Neurological Disorders and Stroke (NINDS)collaborator
- Medical University of South Carolinacollaborator
- Johns Hopkins Universitycollaborator
- University of Michigancollaborator
- Neurocritical Care Research Networkcollaborator
- National Cerebral and Cardiovascular Center, Japancollaborator
- Japan Cardiovascular Research Foundationcollaborator
- Beijing Tiantan Hospitalcollaborator
- China Medical University Hospitalcollaborator
- University Hospital Heidelbergcollaborator
- Seoul National University Hospitalcollaborator
Study Sites (171)
UAB Comprehensive Stroke Center
Birmingham, Alabama, 35249, United States
Maricopa Medical Center
Phoenix, Arizona, 85008, United States
Mayo Clinic Pheonix
Scottsdale, Arizona, 85259, United States
Banner University Medical Center - South Campus
Tuscon, Arizona, 85713, United States
Banner University Medical Center - University Campus
Tuscon, Arizona, 85724, United States
Community Regional Medical Center of Fresno
Fresno, California, 93721, United States
University of California San Diego
La Jolla, California, 92093, United States
Long Beach Memorial Medical Center
Long Beach, California, 90806, United States
Ronald Regan UCLA Medical Center
Los Angeles, California, 90095-9574, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92658, United States
Stanford University
Palo Alto, California, 94304, United States
Sutter Roseville Medical Center
Roseville, California, 95661, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
UCSF Medical Center
San Francisco, California, 94143, United States
Good Samaritan Hospital
San Jose, California, 95124, United States
Santa Clara Valley Medical Center
Santa Clara, California, 95138, United States
Colorado Neurological Institute
Englewood, Colorado, 80113, United States
Yale - New Haven Hospital
New Haven, Connecticut, 06510, United States
Christiana Hospital
Newark, Delaware, 19718, United States
University of Florida Gainesville
Gainesville, Florida, 32611, United States
Baptist Medical Center Jacksonville
Jacksonville, Florida, 32207, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224, United States
University of South Florida, Tampa General Hospital
Tampa, Florida, 33612, United States
Grady Memorial Hospital
Atlanta, Georgia, 30303, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Eastern Idaho Medical Consultants
Idaho Falls, Idaho, 83404, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Southern Illinois University Memorial Medical Center
Springfield, Illinois, 62794-9643, United States
Lutheran Hospital Indiana
Fort Wayne, Indiana, 46804, United States
Parkview Hospital
Fort Wayne, Indiana, 46805, United States
Kansas University Medical Center
Kansas City, Kansas, 66160, United States
University of Kentucky
Lexington, Kentucky, 40536-0296, United States
University of Louisville
Louisville, Kentucky, 40292, United States
West Jefferson Medical Center
Marrero, Louisiana, 70072, United States
Interim LSU Hospital
New Orleans, Louisiana, 70112, United States
Tulane Medical Center
New Orleans, Louisiana, 70112, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Louisiana State University Health Sciences Center, Shreveport
Shreveport, Louisiana, 71103, United States
Maine Medical Center
South Portland, Maine, 04106, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Wayne State University - Detroit Receiving Hospital
Detroit, Michigan, 48201, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Sinai-Grace Hospital
Detroit, Michigan, 48235, United States
Allegiance Health
Jackson, Michigan, 49201, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Essentia Health St. Mary's Medical Center
Duluth, Minnesota, 55805, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55404, United States
St. Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Saint Luke's Neuroscience Institute
Kansas City, Missouri, 64111, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Saint Louis University
St Louis, Missouri, 63104, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
St. Joseph's Regional Medical Center
Clifton, New Jersey, 07012, United States
New Jersey Neuroscience Institute, JFK Medical Center
Edison, New Jersey, 08818, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
New York City Health and Hospitals Corp. / Kings County Hospital
Brooklyn, New York, 11203, United States
Mamoides Medical Center
Brooklyn, New York, 11219, United States
Sister of Charity/Buffalo Mercy Hospital, Catholic Health System
Buffalo, New York, 14214, United States
UHS Wilson Medical Center
Johnson City, New York, 13790, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
SUNY Downstate
New York, New York, 10029, United States
Columbia University
New York, New York, 10032, United States
Lincoln Medical and Mental Health Center
New York, New York, 10451, United States
Rochester General Hospital
Rochester, New York, 14621, United States
Strong Stroke Center
Rochester, New York, 14642, United States
Mission Hospital
Asheville, North Carolina, 28801-4601, United States
Guilford Neurologic Associates
Greenboro, North Carolina, 27405, United States
Vidant Medical Center
Greenville, North Carolina, 27834, United States
Novant Clinical Research Institute/Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Wake Forest Baptist Medical Center (Wake Forest School of Medicine)
Winston-Salem, North Carolina, 27157, United States
Akron General Hospital
Akron, Ohio, 44307, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
Ohio State University - Wexner Medical Center
Columbus, Ohio, 43210, United States
University of Toledo Medical Center
Toledo, Ohio, 43614, United States
Oklahoma University Health Sciences Center (OUHSC)
Oklahoma City, Oklahoma, 73104, United States
Providence Brain and Spine Institute
Portland, Oregon, 97225, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Penn State Univ/ Hershey Med Center
Hershey, Pennsylvania, 17033, United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213, United States
UPMC-Mercy Hospital
Pittsburgh, Pennsylvania, 15219, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
Wellspan York Hospital
York, Pennsylvania, 17403, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Palmetto Health
Columbia, South Carolina, 29203, United States
Vanderbilt Stroke Center
Nashville, Tennessee, 37232, United States
Seton Medical Center Austin
Austin, Texas, 78705, United States
St. David's Medical Center
Austin, Texas, 78705, United States
University Medical Center Brackenridge
Austin, Texas, 78705, United States
UT Southwestern - Parkland Hospital
Dallas, Texas, 75235, United States
Texas Tech University Health Sciences Center
El Paso, Texas, 79430, United States
Valley Baptist Medical Center
Harlingen, Texas, 78550, United States
Memorial Herman - Texas Medical Center
Houston, Texas, 77024, United States
Baylor College of Medicine - Ben Taub Community Hospital
Houston, Texas, 77030, United States
Baylor College of Medicine - St. Luke's Episcopal Hospital
Houston, Texas, 77030, United States
Methodist Hospital - The Neurological Institute
Houston, Texas, 77030, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298-0631, United States
West Virginia University - Ruby Memorial Hospital
Morgantown, West Virginia, 26506, United States
Medical College of Wisconsin
Milwakee, Wisconsin, 53226, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
University of Alberta
Edmonton, Alberta, 2E3.27WMC, Canada
Montreal Neurological Institute and Hospital
Montreal, Quebec, H3A 2B4, Canada
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
Baotou Central Hospital
Baotou, China
Beijing Tiantan Hospital
Beijing, 100050, China
Peking University Third Hospital
Beijing, 100191, China
Datong Third People's Hospital
Datong, China
The First Hospital of Shanxi Medical University
Taiyuan, 030001, China
The First People's Hospital of Taizhou
Taizhou, 318020, China
Tianjin Fourth Central Hospital
Tianjin, 300140, China
Wuhan Brain Hospital
Wuhan, 430019, China
Renmin Hospital of Wuhan University
Wuhan, 430060, China
People's Hopital of Zhengzhou
Zhengzhou, 450003, China
Charité Universtity Medicine Berlin
Berlin, 12203, Germany
University of Bonn
Bonn, 53105, Germany
University Hospital Dresden
Dresden, 01307, Germany
Clinic Frankfurt Hoechst
Frankfurt, 65929, Germany
University Hospital Halle
Halle, 06120, Germany
University Hospital Heidelberg
Heidelberg, 69120, Germany
University Hospital Leipzig
Leipzig, 04103, Germany
University Hospital Mannheim
Mannheim, 68167, Germany
University Hospital Meunster
Münster, 48129, Germany
University of Tubingen
Tübingen, 72076, Germany
Nagoya Medical Center
Nagoya, Aichi-ken, 460-0001, Japan
Nakamura Memorial Hospital
Sapporo, Hokkaido, 060-8570, Japan
Saiseikai Yokohamashi Tobu Hospital
Kanagawa, Kanagowa, 230-8765, Japan
Saiseikai Kumamoto Hospital
Kumamoto, Kumamoto, 861-4193, Japan
Kyushu Medical Center
Fukuoka, 810-8563, Japan
Gifu University Hospital
Gifu, 501-1194, Japan
St. Marianna - Toyoko
Kawasaki, 211-0063, Japan
St. Marianna University Hospital
Kawasaki, 216-8511, Japan
Kobe City Medical Center General Hospital
Kobe, Japan
Kawasaki Medical School
Okayama, 701-0192, Japan
National Cerebral and Cardiovascular Center
Osaka, 565-8565, Japan
Kohnan Hospital
Sendai, Japan
Toranomon Hospital
Tokyo, 105-8470, Japan
Saiseikai Central Hospital - Tokyo
Tokyo, 108-0073, Japan
Keio University Hospital
Tokyo, 160-8582, Japan
Kyorin University
Tokyo, Japan
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Chonnam National University Hospital
Gwangju, 501-757, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Kyung Hee University Hospital
Seoul, 130-702, South Korea
Seoul National University Boramae Hospital
Seoul, 156-707, South Korea
Changhua Christian Hospital
Changhua, Taiwan
Kaohsiung Medical University Hospital
Kaohsiung City, 807, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
China Medical University Hospital
Taichung, 404, Taiwan
Taichung Veterans General Hopital
Taichung, 407, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Shin-Kong Wu Ho-Su Memorial Hospital
Taipei, 111, Taiwan
Tri-Service General Hospital
Taipei, 114, Taiwan
Taipei Veteran's Hospital
Taipei, Taiwan
Related Publications (32)
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.
PMID: 20457956BACKGROUNDAntihypertensive 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.
PMID: 19770736BACKGROUNDQureshi 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.
PMID: 18606927BACKGROUNDQureshi 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.
PMID: 17356194BACKGROUNDQureshi 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.
PMID: 21626077BACKGROUNDQureshi 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.
PMID: 22560810BACKGROUNDQureshi 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.
PMID: 25132910BACKGROUNDQureshi 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.
PMID: 27276234RESULTLi 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.
PMID: 39913881DERIVEDTsukita 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.
PMID: 37586882DERIVEDQureshi 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.
PMID: 35513751DERIVEDTanaka K, Koga M, Fukuda-Doi M, Qureshi AI, Yamamoto H, Miwa K, Ihara M, Toyoda K; ATACH-2 Trial Investigators. Temporal Trajectory of Systolic Blood Pressure and Outcomes in Acute Intracerebral Hemorrhage: ATACH-2 Trial Cohort. Stroke. 2022 Jun;53(6):1854-1862. doi: 10.1161/STROKEAHA.121.037186. Epub 2022 Apr 11.
PMID: 35400202DERIVEDTsukita K, Sakamaki-Tsukita H, Takahashi R. Long-term Effect of Regular Physical Activity and Exercise Habits in Patients With Early Parkinson Disease. Neurology. 2022 Feb 22;98(8):e859-e871. doi: 10.1212/WNL.0000000000013218. Epub 2022 Jan 12.
PMID: 35022304DERIVEDMagid-Bernstein JR, Li Y, Cho SM, Piran PJ, Roh DJ, Gupta A, Shoamanesh A, Merkler A, Zhang C, Avadhani R, Montano N, Iadecola C, Falcone GJ, Sheth KN, Qureshi AI, Rosand J, Goldstein J, Awad I, Hanley DF, Kamel H, Ziai WC, Murthy SB. Cerebral Microbleeds and Acute Hematoma Characteristics in the ATACH-2 and MISTIE III Trials. Neurology. 2022 Mar 8;98(10):e1013-e1020. doi: 10.1212/WNL.0000000000013247. Epub 2021 Dec 22.
PMID: 34937780DERIVEDQureshi AI, Huang W, Lobanova I, Chandrasekaran PN, Hanley DF, Hsu CY, Martin RH, Steiner T, Suarez JI, Yamamoto H, Toyoda K. Effect of Moderate and Severe Persistent Hyperglycemia on Outcomes in Patients With Intracerebral Hemorrhage. Stroke. 2022 Apr;53(4):1226-1234. doi: 10.1161/STROKEAHA.121.034928. Epub 2021 Nov 30.
PMID: 34844422DERIVEDMiwa K, Koga M, Fukuda-Doi M, Yamamoto H, Tanaka K, Yoshimura S, Ihara M, Qureshi AI, Toyoda K. Effect of Heart Rate Variabilities on Outcome After Acute Intracerebral Hemorrhage: A Post Hoc Analysis of ATACH-2. J Am Heart Assoc. 2021 Aug 17;10(16):e020364. doi: 10.1161/JAHA.120.020364. Epub 2021 Aug 13.
PMID: 34387101DERIVEDShoamanesh A, Cassarly C, Morotti A, Romero JM, Oliveira-Filho J, Schlunk F, Jessel M, Butcher K, Gioia L, Ayres A, Vashkevich A, Schwab K, Afzal MR, Martin RH, Qureshi AI, Greenberg SM, Rosand J, Goldstein JN; ATACH-2 and NETT investigators. Intensive Blood Pressure Lowering and DWI Lesions in Intracerebral Hemorrhage: Exploratory Analysis of the ATACH-2 Randomized Trial. Neurocrit Care. 2022 Feb;36(1):71-81. doi: 10.1007/s12028-021-01254-9. Epub 2021 Jul 22.
PMID: 34292474DERIVEDFukuda-Doi M, Yamamoto H, Koga M, Doi Y, Qureshi AI, Yoshimura S, Miwa K, Ishigami A, Shiozawa M, Omae K, Ihara M, Toyoda K. Impact of Renal Impairment on Intensive Blood-Pressure-Lowering Therapy and Outcomes in Intracerebral Hemorrhage: Results From ATACH-2. Neurology. 2021 Aug 31;97(9):e913-e921. doi: 10.1212/WNL.0000000000012442. Epub 2021 Jul 1.
PMID: 34210824DERIVEDYogendrakumar V, Ramsay T, Menon BK, Qureshi AI, Saver JL, Dowlatshahi D. Hematoma Expansion Shift Analysis to Assess Acute Intracerebral Hemorrhage Treatments. Neurology. 2021 Aug 24;97(8):e755-e764. doi: 10.1212/WNL.0000000000012393. Epub 2021 Jun 18.
PMID: 34144995DERIVEDToyoda K, Palesch YY, Koga M, Foster L, Yamamoto H, Yoshimura S, Ihara M, Fukuda-Doi M, Okazaki S, Tanaka K, Miwa K, Hasegawa Y, Shiokawa Y, Iwama T, Kamiyama K, Hoshino H, Steiner T, Yoon BW, Wang Y, Hsu CY, Qureshi AI; ATACH-2 Trial Investigators. Regional Differences in the Response to Acute Blood Pressure Lowering After Cerebral Hemorrhage. Neurology. 2021 Feb 2;96(5):e740-e751. doi: 10.1212/WNL.0000000000011229. Epub 2020 Nov 20.
PMID: 33219136DERIVEDQureshi AI, Huang W, Lobanova I, Hanley DF, Hsu CY, Malhotra K, Steiner T, Suarez JI, Toyoda K, Yamamoto H; Antihypertensive Treatment of Cerebral Hemorrhage 2 Trial Investigators. Systolic Blood Pressure Reduction and Acute Kidney Injury in Intracerebral Hemorrhage. Stroke. 2020 Oct;51(10):3030-3038. doi: 10.1161/STROKEAHA.120.030272. Epub 2020 Aug 25.
PMID: 32838673DERIVEDFukuda-Doi M, Yamamoto H, Koga M, Palesch YY, Durkalski-Mauldin VL, Qureshi AI, Yoshimura S, Okazaki S, Miwa K, Okada Y, Ueda T, Okuda S, Nakahara J, Suzuki N, Toyoda K. Sex Differences in Blood Pressure-Lowering Therapy and Outcomes Following Intracerebral Hemorrhage: Results From ATACH-2. Stroke. 2020 Aug;51(8):2282-2286. doi: 10.1161/STROKEAHA.120.029770. Epub 2020 Jul 6.
PMID: 32623977DERIVEDQureshi AI, Foster LD, Lobanova I, Huang W, Suarez JI. Intensive Blood Pressure Lowering in Patients with Moderate to Severe Grade Acute Cerebral Hemorrhage: Post Hoc Analysis of Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH)-2 Trial. Cerebrovasc Dis. 2020;49(3):244-252. doi: 10.1159/000506358. Epub 2020 Jun 25.
PMID: 32585668DERIVEDToyoda K, Koga M, Yamamoto H, Foster L, Palesch YY, Wang Y, Sakai N, Hara T, Hsu CY, Itabashi R, Sato S, Fukuda-Doi M, Steiner T, Yoon BW, Hanley DF, Qureshi AI; ATACH-2 Trial Investigators. Clinical Outcomes Depending on Acute Blood Pressure After Cerebral Hemorrhage. Ann Neurol. 2019 Jan;85(1):105-113. doi: 10.1002/ana.25379. Epub 2019 Jan 7.
PMID: 30421455DERIVEDMoullaali TJ, Wang X, Martin RH, Shipes VB, Qureshi AI, Anderson CS, Palesch YY. Statistical analysis plan for pooled individual patient data from two landmark randomized trials (INTERACT2 and ATACH-II) of intensive blood pressure lowering treatment in acute intracerebral hemorrhage. Int J Stroke. 2019 Apr;14(3):321-328. doi: 10.1177/1747493018813695. Epub 2018 Nov 12.
PMID: 30418098DERIVEDQureshi AI, Palesch YY, Foster LD, Barsan WG, Goldstein JN, Hanley DF, Hsu CY, Moy CS, Qureshi MH, Silbergleit R, Suarez JI, Toyoda K, Yamamoto H; ATACH 2 Trial Investigators. Blood Pressure-Attained Analysis of ATACH 2 Trial. Stroke. 2018 Jun;49(6):1412-1418. doi: 10.1161/STROKEAHA.117.019845. Epub 2018 May 22.
PMID: 29789395DERIVEDShoamanesh A, Morotti A, Romero JM, Oliveira-Filho J, Schlunk F, Jessel MJ, Ayres AM, Vashkevich A, Schwab K, Afzal MR, Cassarly C, Martin RH, Qureshi AI, Greenberg SM, Rosand J, Goldstein JN; Antihypertensive Treatment of Acute Cerebral Hemorrhage 2 (ATACH-2) and the Neurological Emergencies Treatment Trials (NETT) Network Investigators. Cerebral Microbleeds and the Effect of Intensive Blood Pressure Reduction on Hematoma Expansion and Functional Outcomes: A Secondary Analysis of the ATACH-2 Randomized Clinical Trial. JAMA Neurol. 2018 Jul 1;75(7):850-859. doi: 10.1001/jamaneurol.2018.0454.
PMID: 29710119DERIVEDMorotti A, Boulouis G, Romero JM, Brouwers HB, Jessel MJ, Vashkevich A, Schwab K, Afzal MR, Cassarly C, Greenberg SM, Martin RH, Qureshi AI, Rosand J, Goldstein JN; ATACH-II and NETT investigators. Blood pressure reduction and noncontrast CT markers of intracerebral hemorrhage expansion. Neurology. 2017 Aug 8;89(6):548-554. doi: 10.1212/WNL.0000000000004210. Epub 2017 Jul 12.
PMID: 28701501DERIVEDMorotti A, Brouwers HB, Romero JM, Jessel MJ, Vashkevich A, Schwab K, Afzal MR, Cassarly C, Greenberg SM, Martin RH, Qureshi AI, Rosand J, Goldstein JN; Antihypertensive Treatment of Acute Cerebral Hemorrhage II and Neurological Emergencies Treatment Trials Investigators. Intensive Blood Pressure Reduction and Spot Sign in Intracerebral Hemorrhage: A Secondary Analysis of a Randomized Clinical Trial. JAMA Neurol. 2017 Aug 1;74(8):950-960. doi: 10.1001/jamaneurol.2017.1014.
PMID: 28628707DERIVEDRodriguez-Luna D, Pineiro S, Rubiera M, Ribo M, Coscojuela P, Pagola J, Flores A, Muchada M, Ibarra B, Meler P, Sanjuan E, Hernandez-Guillamon M, Alvarez-Sabin J, Montaner J, Molina CA. Impact of blood pressure changes and course on hematoma growth in acute intracerebral hemorrhage. Eur J Neurol. 2013 Sep;20(9):1277-83. doi: 10.1111/ene.12180. Epub 2013 May 5.
PMID: 23647568DERIVEDToyoda K, Sato S, Koga M, Yamamoto H, Nakagawara J, Furui E, Shiokawa Y, Hasegawa Y, Okuda S, Sakai N, Kimura K, Okada Y, Yoshimura S, Hoshino H, Uesaka Y, Nakashima T, Itoh Y, Ueda T, Nishi T, Gotoh J, Nagatsuka K, Arihiro S, Yamaguchi T, Minematsu K. Run-up to participation in ATACH II in Japan. J Vasc Interv Neurol. 2012 Aug;5(supp):1-5.
PMID: 23230457DERIVEDSato S, Yamamoto H, Qureshi AI, Palesch YY, Toyoda K; ATACH-II study group. [Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH)-II at Japan site: study design and advance construction of domestic research network]. Rinsho Shinkeigaku. 2012;52(9):642-50. doi: 10.5692/clinicalneurol.52.642. Japanese.
PMID: 22989898DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Treatment failures, randomization window, demographics, pre-randomization treatment, low death/disability, favorable baselines, and early termination could limit generalizability of primary (all with intent-to-treat) results and some sub-analyses.
Results Point of Contact
- Title
- Adnan I. Qureshi, MD
- Organization
- University of Minnesota
Study Officials
- STUDY CHAIR
Adnan I Qureshi, MD
University of Minnesota
- STUDY DIRECTOR
Yuko Y Palesch, PhD
Medical University of South Carolina
- PRINCIPAL INVESTIGATOR
Adnan I Qureshi, MD
University of Minnesota
- PRINCIPAL INVESTIGATOR
Yuko Y Palesch, PhD
Medical University of South Carolina
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The trial intervention is conducted open-label to avoid concealing clinically necessary patient blood pressure and intravenous drug administration information. Clinical data including SBP values are primarily taken from entries recorded in to the patient's official medical record by hospital staff and are independently monitor-verified. Assessors for the primary outcome (mRS) at 90 days are are unaware of the treatment assignment or in-hospital clinical course of the subjects assessed. De-identified imaging studies are coded independently of subject number so the central imaging reader is unaware of the treatment assignment, clinical findings, or time points of image acquisition for data recorded from imaging. The study (lead) principal investigator and leadership committee members are unable to associate the treatment assignment of subjects to their outcomes or adverse events for purposes of trial decision-making. Adverse events are adjudicated by an independent oversight committee.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2010
First Posted
August 6, 2010
Study Start
May 15, 2011
Primary Completion
December 21, 2015
Study Completion
March 8, 2016
Last Updated
April 25, 2017
Results First Posted
April 25, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
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.