UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of anti-inflammatory effects of rivaroxaban versus dabigatran in patients with non-valvular atrial fibrillation (RIVAL-AF study) -Multicenter randomized study-
Title of the study (Brief title)	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	Kazuo Kimura
Organization	Yokohama City University Medical Center
Division name	Division of Cardiology
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	Kengo Tsukahara
Organization	Yokohama City University Medical Center
Division name	Division of Cardiology
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
Institute	Division of Cardiology, Yokohama City University Medical Center
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 03 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	There were no significant differences in the time courses of any inflammatory marker between rivaroxaban and dabigatran treatment in patients with AF.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011054