UMIN-CTR Clinical Trial

Basic information
Public title	GENeral practitioners and Embolism pRevention in NVAF patients treated with RivAroxaban : reaL life evidence
Acronym	GENeRAL
Scientific Title	GENeral practitioners and Embolism pRevention in NVAF patients treated with RivAroxaban : reaL life evidence
Scientific Title:Acronym	GENeRAL
Region	Japan

Condition
Condition	Non-valvular atrial fibrillation
Classification by specialty	Cardiology Neurology Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate effectiveness and safety of novel oral Xa inhibitor rivaroxaban in non-valvular atrial fibrillation patients prescribed by general practitioners.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Composite of symptomatic stroke (ischemic or hemorrhagic) and systemic embolism
Key secondary outcomes	- Major Bleeding events (adapeted ISTH standard) - Non Major Bleeding events (without Major Bleeding complications) - Composite of symptomatic stroke (ischemic or hemorrhagic), systemic embolism, myocardial infarction/unstable angina pectoris and cardiovascular death - symptomatic stroke (ischemic or emorrhagic) - symptomatic ischemic stroke - symptomatic hemorrhagic stroke - systemic embolism - Acute myocardial infarction/unstable angina pectoris - cardiovascular death - Deep vein thrombosis/pulmonary thromboembolism - Transient ischemic attack - percutaneous coronary intervention/coronary artery bypass grafting - All-cause death - Comparison the primary outcomes and Major Bleeding complications (adapeted ISTH standard) between EXPAND study and FUSHIMI AF registory - Adverse Event excluding hemorrhagic events - Patients adherence related with stroke or systemic embolism - Correlation with CHADS2 score or other risk factors and outcome events in Japanese patients who administered Rivaroxaban.

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	Non-valvular atrial fibrillation patient who are prescribed Rivaroxaban by General pracctitioners.
Key exclusion criteria	- Patients are contraindicated for rivaroxaban - Patients judged as inappropriate for this study by investigators
Target sample size	5000

Research contact person
Name of lead principal investigator	1st name Kengo Middle name Last name Kusano
Organization	Japan Cardiovascular Research Foundaition
Division name	National Cerebral and Cardiovascular Center
Zip code	564-0027
Address	5-7-1 Fujishirodai, Suita, Osaka 565-8565, Japan
TEL	+81-6-6872-0010
Email	general@jcvrf.jp

Public contact
Name of contact person	1st name Saburo Middle name Last name Saito
Organization	Japan Cardiovascular Research Foundation
Division name	Administration Office
Zip code	564-0027
Address	5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, Japan
TEL	+81-6-6872-0010
Homepage URL
Email	general@jcvrf.jp

Sponsor
Institute	Japan Cardiovascular Research Foundation
Institute
Department

Funding Source
Organization	Bayer Yakuhin, Ltd.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Koyasu neurosurgical clinic
Address	2nd floor of Futamata Kitaguchi Building, 1-6-1, Futamatagawa, Asahi-ku, Yokohama-shi, Kanagawa
Tel	045-360-1114
Email	central-IRB@epmint.co.jp

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	2015 Year 09 Month 28 Day

Related information
URL releasing protocol	No URL
Publication of results	Unpublished

Result
URL related to results and publications	No URL
Number of participants that the trial has enrolled	5732
Results	Currently being analyzed
Results date posted	2020 Year 03 Month 31 Day
Results Delayed	Delay expected
Results Delay Reason	Due to postponement of the conference by coronavirus
Date of the first journal publication of results
Baseline Characteristics	Currently being analyzed
Participant flow	Currently being analyzed
Adverse events	Currently being analyzed
Outcome measures	Currently being analyzed
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 08 Month 25 Day
Date of IRB	2015 Year 09 Month 27 Day
Anticipated trial start date	2015 Year 09 Month 28 Day
Last follow-up date	2018 Year 09 Month 27 Day
Date of closure to data entry
Date trial data considered complete	2019 Year 08 Month 31 Day
Date analysis concluded	2020 Year 06 Month 30 Day

Other
Other related information	Registory Research

Management information
Registered date	2015 Year 09 Month 28 Day
Last modified on	2022 Year 04 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022125