UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017296
Receipt number R000020063
Scientific Title DefinitiVe AntIcoagulatioN for acute Cardio-embolic stroke with atrIal fibrillation
Date of disclosure of the study information 2015/04/27
Last modified on 2017/01/11 09:24:49

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Basic information

Public title

DefinitiVe AntIcoagulatioN for acute Cardio-embolic stroke with atrIal fibrillation

Acronym

DaVinci study

Scientific Title

DefinitiVe AntIcoagulatioN for acute Cardio-embolic stroke with atrIal fibrillation

Scientific Title:Acronym

DaVinci study

Region

Japan


Condition

Condition

acute ischemic stroke

Classification by specialty

Medicine in general Cardiology Neurology
Geriatrics Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine short-term outcomes such as stroke recurrence or bleeding complications during anticoagulant therapy in patients with atrial fibrillation who developed acute cardioembolic ischemic stroke or transient ischemic attack

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1) Stroke recurrence, systemic embolism and hemorrhagic events during acute hospitalization or within the initial 30 days
2) Functional outcomes assessed by the modified Rankin Scale within the observation period or at discharge

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

Consecutive acute ischemic stroke/TIA patients with AF who admitted our participating hospitals within 24 hours after stroke/TIA onset

Key exclusion criteria

Inappropriate patient's conditions for study enrollment in the opinion of the investigator

Target sample size

2000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazumi Kimura

Organization

Nippon Medical School (Kawasaki Medical School)

Division name

Department of Neurological Science, Graduate School of Medicine (Department of Stroke Medicine)

Zip code


Address

1-1-5, Sendagi, Bunkyo-ku, Tokyo (577, Matsushima, Kurashiki, Okayama)

TEL

03-3822-2131

Email

k-kimura@nms.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naoki Saji

Organization

National Center for Geriatrics and Gerontology (Kawasaki Medical School)

Division name

Center for Comprehensive Care and Research on Memory Disorders (Department of Stroke Medicine)

Zip code


Address

7-430, Morioka, Obu, Aichi (577 Matsushima, Kurashiki, Okayama)

TEL

0562-46-2311

Homepage URL

http://www.kawasaki-m.ac.jp/davinci/study.html

Email

sajink@ncgg.go.jp


Sponsor or person

Institute

Department of Stroke Medicine,
Kawasaki Medical School

Institute

Department

Personal name



Funding Source

Organization

Kawasaki Medical School

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

川崎医科大学(岡山県)
東京慈恵会医科大学(東京都)
順天堂大学医学部附属浦安病院 (千葉県)
医療法人社団 製鉄記念八幡病院(福岡県)
済生会熊本病院(熊本県)
福井県済生会病院(福井県)
徳島大学大学院ヘルスバイオサイエンス研究部(徳島県)
熊本赤十字病院(熊本県)
長崎大学附属病院脳卒中センター (長崎県)
岡山日赤病院脳卒中科(岡山県)
奈良県立医科大学(奈良県)
愛媛大学大学院医学系研究科医学専攻(愛媛県)
横浜栄共済病院(神奈川県)
沖縄協同病院(沖縄県)


Other administrative information

Date of disclosure of the study information

2015 Year 04 Month 27 Day


Related information

URL releasing protocol

http://www.kawasaki-m.ac.jp/davinci/study.html

Publication of results

Published


Result

URL related to results and publications

http://link.springer.com/article/10.1007/s11239-016-1376-x

Number of participants that the trial has enrolled


Results

The safety and efficacy of non-vitamin K oral anticoagulant (NOAC) compared with warfarin in treating patients with non-valvular atrial fibrillation (NVAF) who developed acute ischemic stroke or transient ischemic attack (AIS/TIA), particularly those receiving tissue-plasminogen activator (tPA) therapy, remains unclear. Between April 2012 and December 2014, we conducted a multicenter prospective cohort study to assess the current clinical practice for treating such patients. We divided the patients into two groups according to the administration of oral anticoagulants (warfarin or NOACs) and tPA therapy. The risk of any hemorrhagic or ischemic event was compared within 1 month after the onset of stroke. We analyzed 235 patients with AIS/TIA including 73 who received tPA therapy. Oral anticoagulants were initiated within 2-4 inpatient days. NOACs were administered to 49.8 % of patients, who were predominantly male, younger, had small infarcts, lower NIHSS scores, and had a lower all-cause mortality rate (0 vs. 4.2 %, P = 0.06) and a lower risk of any ischemic events (6.0 vs. 7.6 %, P = 0.797) compared with warfarin users. The prevalence of all hemorrhagic events was equivalent between the two groups. Early initiation of NOACs after tPA therapy appeared to lower the risk of hemorrhagic events, although there was no significant difference (0 vs. 5.6 %, P = 0.240). Although more clinicians are apt to prescribe NOACs in minor ischemic stroke, NOAC treatment may provide a potential benefit in such cases. Early initiation of NOACs after tPA therapy may reduce the risk of hemorrhagic events compared with warfarin.

Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2011 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 04 Month 01 Day

Last follow-up date

2014 Year 12 Month 31 Day

Date of closure to data entry

2015 Year 03 Month 31 Day

Date trial data considered complete

2015 Year 04 Month 24 Day

Date analysis concluded

2015 Year 06 Month 30 Day


Other

Other related information

Conference

European Stroke Organisation Conference 2016
May 2016 Barcelona
Definitive anticoagulation for acute ischemic stroke patients with atrial fibrillation: a multicenter prospective cohort study.
Saji N, Kimura K, Shibazaki K, Inoue T, Uemura J, Aoki J, Iguchi Y.

Published article

Safety and efficacy of non-vitamin K oral anticoagulant treatment compared with warfarin in patients with non-valvular atrial fibrillation who develop acute ischemic stroke or transient ischemic attack: a multicenter prospective cohort study (daVinci study).
Saji N, Kimura K, Tateishi Y, Fujimoto S, Kaneko N, Urabe T, Tsujino A, Iguchi Y; daVinci Study Group.

J Thromb Thrombolysis. 2016 Nov;42(4):453-62. doi: 10.1007/s11239-016-1376-x.


Management information

Registered date

2015 Year 04 Month 27 Day

Last modified on

2017 Year 01 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020063


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name