UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021649
Receipt number 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 17:22:12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

National Cerebral and Cardiovascular Center

Institute

Department

Personal name



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

Value
https://center6.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