UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011103 |
|---|---|
| Receipt number | R000013005 |
| Scientific Title | The investigation of the tolerability and the cost, due to the drug change to novel oral anticoagurants (rivaroxaban) from warfarin in patients with nonvalvular atrial fibrillation in the perioperative period |
| Date of disclosure of the study information | 2013/07/03 |
| Last modified on | 2019/01/07 09:14:36 |
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Basic information
Public title
The investigation of the tolerability and the cost, due to the drug change to novel oral anticoagurants (rivaroxaban) from warfarin in patients with nonvalvular atrial fibrillation in the perioperative period
Acronym
The investigation of the tolerability and the cost, due to the drug change to novel oral anticoagurants (rivaroxaban) from warfarin in patients with nonvalvular atrial fibrillation in the perioperative period
Scientific Title
The investigation of the tolerability and the cost, due to the drug change to novel oral anticoagurants (rivaroxaban) from warfarin in patients with nonvalvular atrial fibrillation in the perioperative period
Scientific Title:Acronym
The investigation of the tolerability and the cost, due to the drug change to novel oral anticoagurants (rivaroxaban) from warfarin in patients with nonvalvular atrial fibrillation in the perioperative period
Region
| Japan |
Condition
Condition
Nonvalvular Atrial Fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the tolerability and the cost affected by the oral anticoagurants change to Xarelto from warfarin in patients with nonvalvular atrial fibrillation in the perioperative period
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Inpatient days
2)In-hospital medical expense (including outpatient therapy)
Key secondary outcomes
Tolerability (existence or nonexistence of hemorrhage and orischemic events)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Xarelto is administered to patients at the dose of 15mg/day.
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
1)The patients with nonvalvular atrial fibrillation who are scheduled to undergo surgery recommended to use Heparin
2)Patients who received sufficient explanation before participation in this study, understood it and gave written consent based on their free will
Key exclusion criteria
1)The patients with contraindication of Xarelto
2)The patients who are not allowed to participate in the trial by the principal investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahisa YAMADA |
Organization
Osaka General Medical Center
Division name
Division of Cardiology
Zip code
Address
3-1-56, Bandaihigashi, Sumiyoshi-ku, Osaka
TEL
06-6692-1201
kenkyusien@gh.opho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahisa YAMADA |
Organization
Osaka General Medical Center
Division name
Division of Cardiology
Zip code
Address
3-1-56, Bandaihigashi, Sumiyoshi-ku, Osaka
TEL
06-6692-1201
Homepage URL
kenkyusien@gh.opho.jp
Sponsor or person
Institute
Osaka General Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2013 | Year | 07 | Month | 03 | 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
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 03 | Day |
Last modified on
| 2019 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013005
