UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020806 |
|---|---|
| Receipt number | R000024020 |
| Scientific Title | The effect of rivaroxaban for hemodynamics in left atrium and thrombotic / thrombolytic biomarkers |
| Date of disclosure of the study information | 2016/02/01 |
| Last modified on | 2016/01/30 15:19:17 |
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Basic information
Public title
The effect of rivaroxaban for hemodynamics in left atrium and thrombotic / thrombolytic biomarkers
Acronym
The effect of rivaroxaban for hemodynamics in left atrium and thrombotic / thrombolytic biomarkers
Scientific Title
The effect of rivaroxaban for hemodynamics in left atrium and thrombotic / thrombolytic biomarkers
Scientific Title:Acronym
The effect of rivaroxaban for hemodynamics in left atrium and thrombotic / thrombolytic biomarkers
Region
| Japan |
Condition
Condition
non-valvular atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to elucidate whether novel oral anticoaglant revaroxaban suppresses spontaneous echo contrast in left atrium and thrombotic biomarkers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The disapperance of spontaneous echo contrast in LA after six-week administration of rivaroxaban when we observe LA by transesophageal echo cardiography
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
The patients with non-valvular persistent atrial fibrillation who have never been administered anticoagulants and whose transesophageal echo cardiography show spontaneous echo contrast in left atrium
Key exclusion criteria
paroxysmal atrial fibrillation
obvious thrombus in LA or LAA
cardiac tumor including myxoma
contraindication of rivaroxaban
creatinine clearance under 30ml/min
unstable blood pressure control
unstable control of blood sugar
heart failure functional class NYHA 3 or 4
other unsuitable situation for this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Imai |
Organization
Jichi Medical University
Division name
Division of Cardiovascular Medicine
Zip code
Address
3311-1 Yakushiji Shimotsuke Tochigi
TEL
0285-44-2111
imaiy@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Imai |
Organization
Jichi Medical University
Division name
Division of Cardiovascular Medicine
Zip code
Address
3311-1 Yakushiji Shimotsuke Tochigi
TEL
0285-44-2111
Homepage URL
imaiy@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Bayer
Organization
Division
Category of Funding Organization
Profit organization
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
| 2016 | Year | 02 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 01 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
transesophageal echocardiography for evauation of left atrium spontaneous echo contrast before and six week after administration of rivaroxaban
thrombotic / thrombolytic biomarker evaluation before and six week after administration of rivaroxaban
Management information
Registered date
| 2016 | Year | 01 | Month | 30 | Day |
Last modified on
| 2016 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024020
