Unique ID issued by UMIN | UMIN000006526 |
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Receipt number | 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 16:16:26 |
Antihypertensive Treatment in Acute Cerebral Hemorrhage-II
ATACH-II
Antihypertensive Treatment in Acute Cerebral Hemorrhage-II
ATACH-II
Japan | North America |
Cerebral Hemorrhage
Cardiology | Neurology | Neurosurgery |
Others
NO
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.
Efficacy
Death or disability, defined by modified Rankin scale (mRS) of 4-6 at 3 m following treatment.
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
2
Treatment
Medicine |
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.
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.
18 | years-old | <= |
Not applicable |
Male and Female
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
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
1280
1st name | Adnan |
Middle name | I |
Last name | Qureshi |
University of Minnesota Medical Center
Department of Neurology Professor of Neurology, Neurosurgery, and Radiology
55455
Minneapolis, Minnesota, United States, 55455
612-626-8221
info@atach2.com
1st name | Kazunori |
Middle name | |
Last name | Toyoda, MD, PhD |
National Cerebral and Cardiovascular Center
Department of Cerebrovascular Medicine
565-8565
5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, Japan.
06-6833-5012
http://www.atach-2.com/
toyoda@ncvc.go.jp
University of Minnesota
National Cerebral and Cardiovascular Center
Japan Cardiovascular Research Foundation(National Institutes of Health)
Non profit foundation
National Cerebral and Cardiovascular Center
5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, Japan
06-6833-5012
plandiv@ml.ncvc.go.jp
YES
NCT01176565 (Clinical Trials.gov)
National Institutes of Health (NIH)
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)
2011 | Year | 10 | Month | 14 | Day |
http://www.atach-2.com/
Published
https://www.nejm.org/doi/full/10.1056/NEJMoa1603460
1000
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.
2019 | Year | 03 | Month | 12 | Day |
2016 | Year | 06 | Month | 08 | Day |
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.
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).
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).
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.
Completed
2010 | Year | 10 | Month | 20 | Day |
2011 | Year | 03 | Month | 11 | Day |
2011 | Year | 10 | Month | 01 | Day |
2015 | Year | 09 | Month | 14 | Day |
2016 | Year | 02 | Month | 10 | Day |
2016 | Year | 03 | Month | 01 | Day |
2016 | Year | 03 | Month | 31 | Day |
Protocol Amendment for
Ver.4.0(September 23, 2011)
Ver.5.0(March 23, 2012)
2011 | Year | 10 | Month | 12 | Day |
2019 | Year | 03 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007737
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