UMIN-CTR Clinical Trial

Basic information
Public title	Influences of anticoagulant treatment (RIbaroxaban vs warfarin) on Systemic inflammative markers in patients with Heart Failure and atrial fibrillation
Acronym	Influences of anticoagulant treatment (RIbaroxaban vs warfarin) on Systemic inflammative markers in patients with Heart Failure and atrial fibrillation (IRIS-HF)
Scientific Title	Influences of anticoagulant treatment (RIbaroxaban vs warfarin) on Systemic inflammative markers in patients with Heart Failure and atrial fibrillation
Scientific Title:Acronym	Influences of anticoagulant treatment (RIbaroxaban vs warfarin) on Systemic inflammative markers in patients with Heart Failure and atrial fibrillation (IRIS-HF)
Region	Japan

Condition
Condition	Heart failure with atrial fibrillation
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to copmare the effects of ribaroxaban vs warfarin on systemic inflammatory biomarkers in the patients with heart failure and atrial fibrillation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in high sensitive CRP during the treatments (after 12 weeks, 48 weeks)
Key secondary outcomes	1) Changes in plasma levels of pentraxin 3 (Baseline vs. treatment after 3months) 2) Changes in plasma levels of GDF15 (Baseline vs. treatment after 3months) 3) Changes in plasma levels of matrix gla protein (Baseline vs. treatment after 3months) 4) Changes in plasma levels of thrombin-antithrombin complex (Baseline vs. treatment after 3months) 5) Changes in plasma levels of prothrombin fragment 1+2 (Baseline vs. treatment after 3months) 6) Changes in plasma levels of BNP (Baseline vs. treatment after 3months) 7) Occurrences of combined clinical events (either cardiovascular death or hospitalization due to cardiovascular disease) 8) Occurrences of combined clinical events (either cardiovascular death or hospitalization due to heart failure) 9) Occurrences of cardiovascular death 10) Occurrences of hospitalization due to cardiovascular disease 11) Occurrences of cardiovascular death due to heart failure 12) all causes of death 13) all causes of hospitalization 14) Occurrences of hospitalization due to stroke 15) Occurrences of intracardiac thrombus

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Treatment will be started with 15 mg of rivaroxaban. If the patient represents a lower creatinine clearance of 30 - 49 minutes, treatment will be deceased to 10 mg. The patients in this group will be prohibited to change to other treatment: other Xa inhibitors or warfarin, during the protocol. In the case when a patient is currently receiving warfarin, it will be replaced with Rivaoxaban given the following conditions: If PT-INR is less than 2.0 then rivaroxaban can be started.
Interventions/Control_2	While monitoring PT-INR, the dose of warfarin will be determined in accordance with the guidelines of the Japanese Cardiovascular Society. Patients in this group will be prohibited to change to other treatments of Xa inhibitors.
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	1) Age: from 20 years old, less than 85 years old. 2) Diagnosis of heart failure. (The patients with heart failure is defined if following either criteria is fullfilled: 2-1: hospitalizing patients due to heart failure, 2-2: patients who has history of heart failure hospitalization, 2-3: representing both heart failure symptom (>=NYHA 2) and plasma BNP levels>=100pg/ml within 6months. 3) paroxymal atrial fibrillation or consistent atrial fibrillation. 4) obtained written informed consent
Key exclusion criteria	1) the patients currently receving novel anti-coaglants) 2) the patients with intraventricular thrombus 3) the patients with moderate or severe valvular heart disease 4) the patients requiring mechanical circulatory support 5) the patients waiting for cardiovascular surgery 6) the patients with infective disease or autoimmune disease, or receving steroid 7) the patients with cardiac sarcoidosis 8) the patients who start to receive statin or acetylsaliccylic acid 9) the paients who occurred myocardial infarction or stroke or systemic embolism. 10) the patients who represent creatnine clearance 15ml/min 11) liver cirrhosis, Child B or C 12) intracranial hemorrhage or gastrointenstinal bleeding within 6 months 13) pregnant women 14) the patients receiving cobicistat or HIV protease 15) the patients receiving azole antifungal agents 16) the patiens with warfarin or ribaroxaban sensitivity 17) the patients receiving menatetrenone 18) the patients receiving iguratimod 19) the patiens with advanced cancer 20) the patiens who are participating other prospective clinical trials 21) The physician judge to be unsuitable for the enrollment to this study due to any other reason.
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Middle name Last name Toshihisa Anzai
Organization	National Cerebral and Cardiovascular Center
Division name	Department of cardiovascular medicine
Zip code
Address	Fujishirodai 5-7-1, Suita
TEL	06-6833-5012
Email	anzai@ncvc.go.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroyuki Takahama
Organization	National Cerebral and Cardiovascular Center
Division name	Department of cardiovascular medicine
Zip code
Address	Fujishirodai 5-7-1, Suita
TEL	06-6833-5012
Homepage URL
Email	takahama@ncvc.go.jp

Sponsor
Institute	National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization	Japan Cardiovascular Research Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
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

Other administrative information
Date of disclosure of the study information	2016 Year 04 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	Open public recruiting
Date of protocol fixation	2016 Year 03 Month 07 Day
Date of IRB
Anticipated trial start date	2016 Year 04 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

Management information
Registered date	2016 Year 03 Month 28 Day
Last modified on	2017 Year 09 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024511

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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