UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009553 |
|---|---|
| Receipt number | R000011054 |
| Scientific Title | Comparison of anti-inflammatory effects of rivaroxaban versus dabigatran in patients with non-valvular atrial fibrillation (RIVAL-AF study) -Multicenter randomized study- |
| Date of disclosure of the study information | 2012/12/14 |
| Last modified on | 2019/01/04 16:51:14 |
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Basic information
Public title
Comparison of anti-inflammatory effects of rivaroxaban versus dabigatran in patients with non-valvular atrial fibrillation (RIVAL-AF study) -Multicenter randomized study-
Acronym
Anti-inflammatory effects of rivaroxaban versus dabigatran
Scientific Title
Comparison of anti-inflammatory effects of rivaroxaban versus dabigatran in patients with non-valvular atrial fibrillation (RIVAL-AF study) -Multicenter randomized study-
Scientific Title:Acronym
Anti-inflammatory effects of rivaroxaban versus dabigatran
Region
| Japan |
Condition
Condition
non-valvular atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the antiinflammatory effets of rivaroxaban compared with dabigatran in patients with atrial fibrillation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
median variation of inflammatory markers (including high sensitivity C reactive protein, pentraxin3, interleukin-6, interleukin-18) between at baseline and 12 months later in each treatment group
Key secondary outcomes
(1)change over time of above inflammatory markers during 12 months follow-up period (at baseline, 1 month, 3 months, 6 months, and 12 months later) in each treatment group
(2)frequency of 12-month adverse cardiac and cerebrovascular events (including cardiovascular death, myocardial infarction, revascularization, ischemic stroke and systemic embolism)
(3)frequency of 12-month major bleeding (defined as ISTH criteria)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After baseline assessment of blood examination, patients are assigned to receive rivaroxaban 15mg once daily for 12 months according to a computer-generated randomization sequence at the central registration center. Patients with cleatinine crealance 30-49 mL/min receive rivaroxaban 10mg once daily.
Interventions/Control_2
After baseline assessment of blood examination, patients are assigned to receive dabigatran 150mg twice daily for 12 months according to a computer-generated randomization sequence at the central registration center. Patients at a high risk of bleeding receive dabigatran 110mg twice daily.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with non-valvular atrial fibrillation who have no contraindication for anticoagulantion with a CHADS2-VASc score of 1 or more
Key exclusion criteria
(1)stroke or systemic embolism within 6 months before enrollment
(2)acute coronary syndromes or peripheral artery disease within 6 months before enrollment
(3)acute heart failure
(4)severe chronic renal failure (creatinine clearance < 30mL/min.)
(5)receiving dual antiplatelet therapy
(6)patients with a body weight of 50kg or less
(7)uncontrolled hypertention
(8)active malignancy
(9)patients undergoing surgery within 6 months before enrollment
(10)collagen disease
(11)infectious disease
(12)patients who are planned to undergoing catheter ablation for atrial fibrillation
(13)contraindication of rivaroxaban or dabigatran
(14)patients who are not allowed to participate in the trial by judgement of the treating physician
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Kimura |
Organization
Yokohama City University Medical Center
Division name
Division of Cardiology
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
c-kimura@urahp.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kengo Tsukahara |
Organization
Yokohama City University Medical Center
Division name
Division of Cardiology
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
k-tsuka@urahp.yokohama-cu.ac.jp
Sponsor or person
Institute
Division of Cardiology, Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin, Ltd.
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
横浜市立大学附属市民総合医療センター（神奈川県）、横浜市立大学付属病院（神奈川県）、神奈川県立循環器呼吸器病センター（神奈川県）、横浜船員保険病院（神奈川県）、国際親善総合病院（神奈川県）、済生会横浜市南部病院（神奈川県）、横須賀市立市民病院（神奈川県）、藤沢市民病院（神奈川県）、神奈川県立足柄上病院（神奈川県）、国立病院機構相模原病院（神奈川県）、茅ケ崎市立病院（神奈川県）、国際医療福祉大学熱海病院（静岡県）、大森赤十字病院（東京都）、秦野赤十字病院（神奈川県）、藤沢湘南台病院（神奈川県）、長津田厚生病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
There were no significant differences in the time courses of any inflammatory marker between rivaroxaban and dabigatran treatment in patients with AF.
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 | 03 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2015 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 14 | Day |
Last modified on
| 2019 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011054
