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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name