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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000026694
Receipt No. R000030644
Scientific Title Bleeding and thrombotic risk evaluation in patients with atrial fibrillation under coronary intervention
Date of disclosure of the study information 2017/04/10
Last modified on 2017/10/04

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Basic information
Public title Bleeding and thrombotic risk evaluation
in patients with atrial fibrillation under coronary intervention
Acronym BIWACO study
Scientific Title Bleeding and thrombotic risk evaluation
in patients with atrial fibrillation under coronary intervention
Scientific Title:Acronym BIWACO study
Region
Japan

Condition
Condition atrial fibrillation and ischemic heart disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 analysis of bleeding risks under anticoagulation therapy using three bleeding scores in atraila fibrillation patients with coronary stent therapy in Shiga prefecture
Basic objectives2 Others
Basic objectives -Others risk scoring of bleeding in recruited patients and follow-up observation
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation of bleeding and systemic thrombosis events using PARIS risk score,DAPT score, ORBIT score and PRECISE-DAPT score
Key secondary outcomes all cause of death, cardiovascular death, hemorrhagic events, hospitalization for heart faliure, myocardial infarction, cerebral infarction and coronary revasculization

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
20 years-old <=
Age-upper limit
95 years-old >=
Gender Male and Female
Key inclusion criteria 1.patients with atraial fibrillation documented with ECG

2.patientes received PCI therapy for coronary arterial stenosis
3.age; 20~95
4.More than one Risk factor including Heart failure, hpertension, DM and history of stoke
Key exclusion criteria 1.patients with anemia who were previously needed transfusion
2.severe renal and liver injury
3.Possible pregnancy patients
4.intolerance for antiplateletand/or anticoagulation therapy
5.uncontroled hyertension(BP>180mmHg)
Target sample size 450

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsuyuki Wada
Organization Kusatsu General Hospital
Division name Division of Cardiology
Zip code
Address 1660 Yabase, Kusatsu, Shiga
TEL 077-563-8866
Email wada@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsuyuki Wada
Organization Kusatu General Hospital
Division name Division of Cardiology
Zip code
Address 1660 Yabase, Kusatsu, Shiga
TEL 077-563-8866
Homepage URL
Email wada@belle.shiga-med.ac.jp

Sponsor
Institute Kusatu General Hospital
Division of Cardiology
Institute
Department

Funding Source
Organization Kusatu General Hospital
Organization
Division
Category of Funding Organization Self funding
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 草津総合病院、湖東記念病院、甲賀病院、長浜赤十字病院、地域医療機能推進機構滋賀病院

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Date of protocol fixation
2016 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
2018 Year 06 Month 30 Day
Date trial data considered complete
2018 Year 09 Month 30 Day
Date analysis concluded
2018 Year 11 Month 30 Day

Other
Other related information Evaluation of bleeding risks of both anticoagulation and antiplatelet therapy in atrila fibrillation patients with PCI therapy in Shiga prefecture

Management information
Registered date
2017 Year 03 Month 24 Day
Last modified on
2017 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030644

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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