UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	DefinitiVe AntIcoagulatioN for acute Cardio-embolic stroke with atrIal fibrillation
Title of the study (Brief title)	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	Kazumi Kimura
Organization	Nippon Medical School (Kawasaki Medical School)
Division name	Department of Neurological Science, Graduate School of Medicine (Department of Stroke Medicine)
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	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)
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
Institute	Department of Stroke Medicine, Kawasaki Medical School
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 12 Month 01 Day
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

Related information
URL releasing protocol	http://www.kawasaki-m.ac.jp/davinci/study.html
Publication of results	Published
URL releasing results	http://link.springer.com/article/10.1007/s11239-016-1376-x
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020063