Unique ID issued by UMIN | UMIN000021649 |
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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 |
Influences of anticoagulant treatment (RIbaroxaban vs warfarin) on Systemic inflammative markers in patients with Heart Failure and atrial fibrillation
Influences of anticoagulant treatment (RIbaroxaban vs warfarin) on Systemic inflammative markers in patients with Heart Failure and atrial fibrillation (IRIS-HF)
Influences of anticoagulant treatment (RIbaroxaban vs warfarin) on Systemic inflammative markers in patients with Heart Failure and atrial fibrillation
Influences of anticoagulant treatment (RIbaroxaban vs warfarin) on Systemic inflammative markers in patients with Heart Failure and atrial fibrillation (IRIS-HF)
Japan |
Heart failure with atrial fibrillation
Cardiology |
Others
NO
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
Efficacy
Exploratory
Changes in high sensitive CRP during the treatments (after 12 weeks, 48 weeks)
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
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
2
Treatment
Medicine |
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.
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.
20 | years-old | <= |
85 | years-old | > |
Male and Female
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
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.
70
1st name | |
Middle name | |
Last name | Toshihisa Anzai |
National Cerebral and Cardiovascular Center
Department of cardiovascular medicine
Fujishirodai 5-7-1, Suita
06-6833-5012
anzai@ncvc.go.jp
1st name | |
Middle name | |
Last name | Hiroyuki Takahama |
National Cerebral and Cardiovascular Center
Department of cardiovascular medicine
Fujishirodai 5-7-1, Suita
06-6833-5012
takahama@ncvc.go.jp
National Cerebral and Cardiovascular Center
Japan Cardiovascular Research Foundation
Non profit foundation
NO
2016 | Year | 04 | Month | 01 | Day |
Unpublished
Open public recruiting
2016 | Year | 03 | Month | 07 | Day |
2016 | Year | 04 | Month | 01 | Day |
2016 | Year | 03 | Month | 28 | Day |
2017 | Year | 09 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024511
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