UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017523 |
|---|---|
| Receipt number | R000020309 |
| Scientific Title | Prospective and Non-interventional registry to Investigate Effectiveness and Safety of Rivaroxaban on Prevention of Stroke and Systemic Embolism in Patients with Non-valvular Atrial Fibrillation at Fukui Red Cross Hospital |
| Date of disclosure of the study information | 2015/05/12 |
| Last modified on | 2015/05/12 16:13:40 |
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Basic information
Public title
Prospective and Non-interventional registry to Investigate Effectiveness and Safety of Rivaroxaban on Prevention of Stroke and Systemic Embolism in Patients with Non-valvular Atrial Fibrillation at Fukui Red Cross Hospital
Acronym
Prospective and Non-interventional registry to Investigate pharmacokinetics (for the coagulation/fibrinolysis status and vascular function) and Safety of Rivaroxaban in Patients with Non-valvular Atrial Fibrillation (FENIX Registry)
Scientific Title
Prospective and Non-interventional registry to Investigate Effectiveness and Safety of Rivaroxaban on Prevention of Stroke and Systemic Embolism in Patients with Non-valvular Atrial Fibrillation at Fukui Red Cross Hospital
Scientific Title:Acronym
Prospective and Non-interventional registry to Investigate pharmacokinetics (for the coagulation/fibrinolysis status and vascular function) and Safety of Rivaroxaban in Patients with Non-valvular Atrial Fibrillation (FENIX Registry)
Region
| Japan |
Condition
Condition
Non-valvular atrial fibrillation (In the present study, non-valvular atrial fibrillation refers to atrial fibrillation without a history of prosthetic valve replacement or mitral valve stenosis.)
Classification by specialty
| Cardiology | Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The assessment with Quality of Life(QOL) and examination of the coagulation/fibrinolysis status and vascular function using a novel oral Xa inhibitor for stroke and systemic embolism, namely rivaroxaban, in non-valvular atrial fibrillation patients are evaluated in clinical practice.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The assessment with Quality of Life(QOL)
The examination of coagulation/fibrinolysis status and vascular function
Key secondary outcomes
Secondary efficacy endpoints
- Combinations of symptomatic stroke (ischemic or hemorrhagic),systemic embolism, myocardial infarction and cardiovascular death
- Symptomatic ischemic stroke
- Symptomatic hemorrhagic stroke
- Systemic embolism
- Acute myocardial infarction/unstable angina pectoris
- Cardiovascular death
- Deep vein thrombosis/pulmonary thromboembolism
- Transient ischemic attack
- Interventional/surgical treatment
- All-cause death
Secondary safety endpoint
- Clinically insignificant hemorrhagic events (hemorrhagic events other than clinically significant hemorrhagic events)
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
Patients who meet all the criteria below
1) Patients aged over 20 years
2) Patients diagnosed with non-valvular atrial fibrillation
3) Patients have newly anticoagulation planned with rivaroxaban
4) Patients from whom written informed consent has been obtained
5) Patients have availability for follow-up as outpatient visit(PS3<=)
Key exclusion criteria
The following patients in whom rivaroxaban is contraindicated for use
- Patients with a history of allergies to the ingredients contained in this drug
- Patients having a hemorrhagic event (intracranial hemorrhage, gastrointestinal hemorrhage or other clinically significant hemorrhagic events)
- Patients having liver disease complicated with coagulation disorder or those having moderate or worse liver disorder (Grade B or C in accordance with the Child-Pugh classification)
- Patients having renal failure (creatinine clearance <15 mL/min)
- Women who are or are likely to be pregnant
- Patients who are treated with HIV protease inhibitors (including ritonavir, atazanavir and indinavir)
- Patients who are treated with oral or injectable formulations of azole antifungal drugs (including itraconazole, voriconazole and ketoconazole (excluding fluconazole))
-Patients with acute bacterial endocarditis
- Patients have remaining effects are received with other anticoagulation therapy
-Patients are unstable state of blood pressure(18/120mmHg>)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshinari Tsubokawa |
Organization
Fukui Red Cross Hospital
Division name
Cardiology
Zip code
Address
2-4-1,Tsukimi,Fukui,Japan 918-8501
TEL
0776-36-3630
toshi_s1209@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshinari Tsubokawa |
Organization
Fukui Red Cross Hospital
Division name
Cardiology
Zip code
Address
2-4-1,Tsukimi,Fukui,Japan 918-8501
TEL
0776-36-3630
Homepage URL
toshi_s1209@yahoo.co.jp
Sponsor or person
Institute
Fukui Red Cross Hospital
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
| 2015 | Year | 05 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 12 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A randomized, double-blind, comparative study (Study ROCKET AF) was performed overseas using 14,264 non-valvular atrial fibrillation patients and warfarin as a control drug. The results of this study suggest that rivaroxaban is not inferior to warfarin in prevention of stroke and is equivalent to warfarin in safety.
In Japan, Study J-ROCKET AF was performed using 1,280 Japanese non-valvular atrial fibrillation patients. The results of this study also suggest that rivaroxaban is not inferior to warfarin in safety and that even though the power is low, rivaroxaban is effective in preventing ischemic stroke.
Management information
Registered date
| 2015 | Year | 05 | Month | 12 | Day |
Last modified on
| 2015 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020309
