UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The retrospective study of antithrombotic therapies in cardiovascular diseases to elucidate the clinical problems and to develop management strategies.
Title of the study (Brief title)	The retrospective study of antithrombotic therapies in cardiovascular diseases to elucidate the clinical problems and to develop management strategies.
Region	Japan

Condition
Condition	Cardiovascular diseases
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to elucidate appropriate strategies of antithrombotic therapies in patients with atrial fibrillation and other cardiovascular diseases. To do this, we will retrospectively evaluate both thromboembolic and bleeding events associated with antithrombotic therapies in patients enrolled in the Chronic Heart Failure Analysis and Registry in the Tohoku District 2 (CHART-2) study (NCT00418041, UMIN000000562). Also, the result will be compared with other large-scale cohort studies conducted in Japan.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Thromboembolic and bleeding events associated with antithrombotic therapies
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Atrial fibrillation/atrial flutter, and other cardiovascular diseases
Key exclusion criteria	Not applicable
Target sample size	33700

Research contact person
Name of lead principal investigator	Hiroaki Shimokawa
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Address	1-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan
TEL	+81-22-717-7153
Email	shimo@cardio.med.tohoku.ac.jp

Public contact
Name of contact person	Yasuhiko Sakata
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Address	1-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan
TEL	+81-22-717-7153
Homepage URL
Email	sakatayk@cardio.med.tohoku.ac.jp

Sponsor
Institute	Departments of Cardiovascular Medicine and Evidence-based Cardiovascular Medicine, Tohoku University Graduate School of Medicine / Tohoku Heart Failure Association
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
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

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 27 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 05 Month 25 Day
Anticipated trial start date	2016 Year 06 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Under analysis

Management information
Registered date	2016 Year 05 Month 26 Day
Last modified on	2017 Year 02 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025892