UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006526
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

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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 or person

Institute

University of Minnesota
National Cerebral and Cardiovascular Center

Institute

Department

Personal name



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

Value
https://center6.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