UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019135 |
|---|---|
| Receipt number | R000022125 |
| Scientific Title | GENeral practitioners and Embolism pRevention in NVAF patients treated with RivAroxaban : reaL life evidence |
| Date of disclosure of the study information | 2015/09/28 |
| Last modified on | 2022/04/11 13:53:22 |
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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
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
general@jcvrf.jp
Sponsor or person
Institute
Japan Cardiovascular Research Foundation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022125
