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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021649
Receipt No. R000024511
Scientific Title Influences of anticoagulant treatment (RIbaroxaban vs warfarin) on Systemic inflammative markers in patients with Heart Failure and atrial fibrillation
Date of disclosure of the study information 2016/04/01
Last modified on 2017/09/28

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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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