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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006526
Receipt No. R000007737
Scientific Title Antihypertensive Treatment in Acute Cerebral Hemorrhage-II
Date of disclosure of the study information 2011/10/14
Last modified on 2019/03/12

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Basic information
Public title Antihypertensive Treatment in Acute Cerebral Hemorrhage-II
Acronym ATACH-II
Scientific Title Antihypertensive Treatment in Acute Cerebral Hemorrhage-II
Scientific Title:Acronym ATACH-II
Region
Japan North America

Condition
Condition Cerebral Hemorrhage
Classification by specialty
Cardiology Neurology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the therapeutic benefit of intensive SBP treatment (SBP<140 mmHg) compared with standard SBP treatment (SBP<180 mmHg) in reducing the proportion of patients with death and disability (mRS of 4-6) at Day 90 among subjects with ICH treated within 4.5 hours of symptom onset.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Death or disability, defined by modified Rankin scale (mRS) of 4-6 at 3 m following treatment.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Standard treatment group:
The goal for the standard BP reduction group is to reduce and maintain SBP<180 mmHg for 24 hours after randomization, with IV nicardipine.
Interventions/Control_2 Intensive treatment group:
The goal for the intensive BP reduction group is to reduce and maintain SBP <140 mmHg for 24 hours after randomization, with IV nicardipine.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.IV nicardipine can be initiated within 4.5 hours of symptom onset
2.Clinical signs consistent with the diagnosis of stroke, including impairment of language, motor function, cognition, and/or gaze, vision, or neglect
3.Total GCS score(aggregate of verbal, eye, & motor response scores) of 5 or greater at ED arrival
4.CT scan demonstrates intraparenchymal hematoma with manual hematoma volume measurement <60 cc
5.For subjects randomized prior to infusion start: Admission SBP greater than 180 mmHg but less than 240 mmHg AND WITHOUT spontaneous SBP reduction to below 180 mmHg at the time of randomization
OR
For subjects randomized after infusion start: Admission SBP greater than 180 mmHg but less than 240 mmHg AND WITHOUT SBP reduction to below 140 mmHg at the time of randomization
6.Informed consent obtained by subject, legally authorized representative, or next of kin
Key exclusion criteria 1.ICH is due to previously known neoplasms, AVM, or aneurysms
2.Intracerebral hematoma considered to be related to trauma
3.ICH located in infratentorial regions such as pons or cerebellum
4.IVH associated with intraparenchymal hemorrhage and blood completely fills one lateral ventricle or more than half of both ventricles
5.Patient to receive immediate surgical evacuation
6.Current pregnancy, parturition within previous 30 days or active lactation
7.Use of warfarin within the last 5 days and INR >4
8.A platelet count less than 50,000/mm3
9.Known sensitivity to nicardipine
10.Pre-morbid disability requiring assistance in ambulation or activities of daily living
11.Subjects living will precludes aggressive ICU management
12.Subject is currently participating in another interventional clinical trial
Target sample size 1280

Research contact person
Name of lead principal investigator
1st name Adnan
Middle name I
Last name Qureshi
Organization University of Minnesota Medical Center
Division name Department of Neurology Professor of Neurology, Neurosurgery, and Radiology
Zip code 55455
Address Minneapolis, Minnesota, United States, 55455
TEL 612-626-8221
Email info@atach2.com

Public contact
Name of contact person
1st name Kazunori
Middle name
Last name Toyoda, MD, PhD
Organization National Cerebral and Cardiovascular Center
Division name Department of Cerebrovascular Medicine
Zip code 565-8565
Address 5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, Japan.
TEL 06-6833-5012
Homepage URL http://www.atach-2.com/
Email toyoda@ncvc.go.jp

Sponsor
Institute University of Minnesota
National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization Japan Cardiovascular Research Foundation(National Institutes of Health)
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Cerebral and Cardiovascular Center
Address 5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, Japan
Tel 06-6833-5012
Email plandiv@ml.ncvc.go.jp

Secondary IDs
Secondary IDs YES
Study ID_1 NCT01176565 (Clinical Trials.gov)
Org. issuing International ID_1 National Institutes of Health (NIH)
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 国立循環器病研究センター(脳血管内科,脳神経内科),中村記念病院(脳神経外科),広南病院(脳血管内科),杏林大学(脳神経外科),聖マリアンナ医科大学(神経内科),(国)名古屋医療センター(神経内科),神戸市立医療センター中央市民病院(神経内科),川崎医科大学(脳卒中医学), 国立九州医療センター(脳血管内科),岐阜大学(脳神経外科),東京都済生会中央病院(神経内科、脳神経外科),虎の門病院(神経内科),慶応大学(神経内科),聖マリアンナ医科大学東横病院(脳卒中科),済生会横浜市東部病院(脳血管内科) 

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 14 Day

Related information
URL releasing protocol http://www.atach-2.com/
Publication of results Published

Result
URL related to results and publications https://www.nejm.org/doi/full/10.1056/NEJMoa1603460
Number of participants that the trial has enrolled 1000
Results We conducted a multicenter trial where eligible subjects with ICH were randomized to intensive (<140 mm Hg) and standard (<180 mm Hg) SBP reduction in a 1:1 ratio <4.5h. The primary outcome of death and disability was ascertained at 3-M post randomization. Compared with standard SBP reduction, intensive SBP reduction in patients with ICH did not lower the rate of death and disability despite achieving a small magnitude reduction in hematoma expansion.
Results date posted
2019 Year 03 Month 12 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2016 Year 06 Month 08 Day
Baseline Characteristics The mean pre-randomization systolic blood pressures were 200 mm Hg in to the intensive group and 201.1 mm Hg in the standard group. The proportion of subjects with Glasgow coma scale of 15 was similar (55 percent and 56.8 percent). The median hematoma volume was also similar (10.3 and 10.2 milliliters). Other demographic and baseline clinical characteristics were similar between the two groups.
Participant flow A total of 8,532 patients were screened for enrollment in the trial. The 1,000 subjects randomized were equally distributed (500 to intensive and 500 to standard treatment group).
Adverse events The proportion with hematoma expansion, defined as >33 percent increase in the hematoma volume from baseline to 24 hours, was 18.9 percent and 24.4 percent, for intensive and standard treatment groups, respectively (relative risk 0.78, 95 percent confidence interval 0.58, 1.03).
Outcome measures The proportion of death and disability at 3 months was observed in 186 of 481 (38.7 percent) subjects randomized to intensive treatment and 181 of 480 (37.7 percent) subjects randomized to standard treatment (relative risk of1.03, 95 percent confidence interval 0.84, 1.25 in intent to treat analysis), adjusted for age, initial Glasgow Coma scale, and presence/absence of intraventricular hemorrhage.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 10 Month 20 Day
Date of IRB
2011 Year 03 Month 11 Day
Anticipated trial start date
2011 Year 10 Month 01 Day
Last follow-up date
2015 Year 09 Month 14 Day
Date of closure to data entry
2016 Year 02 Month 10 Day
Date trial data considered complete
2016 Year 03 Month 01 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information Protocol Amendment for
Ver.4.0(September 23, 2011)
Ver.5.0(March 23, 2012)

Management information
Registered date
2011 Year 10 Month 12 Day
Last modified on
2019 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007737

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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