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
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
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
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
