Unique ID issued by UMIN | UMIN000016459 |
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Receipt number | R000019116 |
Scientific Title | Change from Vitamin K Antagonist to Factor Xa inhibitor Improves Pulse Wave Velocity |
Date of disclosure of the study information | 2015/02/10 |
Last modified on | 2019/08/11 09:33:56 |
Change from Vitamin K Antagonist to Factor Xa inhibitor Improves Pulse Wave Velocity
K2-SUMMIT 3
Change from Vitamin K Antagonist to Factor Xa inhibitor Improves Pulse Wave Velocity
K2-SUMMIT 3
Japan |
Non-valvular atrial fibrillation requiring anti-coagulation therapy
Cardiology |
Others
NO
To test whether drug change from warfarin to rivaroxaban improves pulse wave velocity, a marker of atherosclerosis
Efficacy
Confirmatory
Explanatory
Phase IV
Improvement of pulse wave velocity 3 months after drug change
uncarboxylated osteocalcin, high sensitive C-reactive protein and clinical outcomes including death, myocardial infarction, stroke and major bleeding according to ISTH definition
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Rivaroxaban
Warfarin
21 | years-old | <= |
Not applicable |
Male and Female
Non valvular atrial fibrillation treated with warfarin for more than 6 months but less than 10 years
1) contraindication against warfarin and/or rivaroxaban
2) pregnant woman
3) peripheral artery disease difficult to measure pulse wave velocity
4) unstable blood pressure
5) under dual antiplatelet therapy
6) younger than 21 years old
80
1st name | Yuji |
Middle name | |
Last name | Ikari |
Tokai University
Cardiology
259-1193
143 Shimokasuya, Isehara, Kanagawa
0463-93-1121
ikari@is.icc.u-tokai.ac.jp
1st name | Fumie |
Middle name | |
Last name | Saito |
Tokai University
Cardiology
259-1193
143 Shimokasuya, Isehara, kanagawa
0463-93-1121
f.saito@tokai-u.jp
Tokai University
Bayer
Profit organization
Tokai University
143 Shimokasuya, Isehara, Kanagawa
0463-93-1121
tokai-rinsho@ml.tokai-u.jp
NO
2015 | Year | 02 | Month | 10 | Day |
Unpublished
80
Completed
2014 | Year | 10 | Month | 14 | Day |
2014 | Year | 12 | Month | 14 | Day |
2015 | Year | 02 | Month | 10 | Day |
2019 | Year | 03 | Month | 31 | Day |
2015 | Year | 02 | Month | 06 | Day |
2019 | Year | 08 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019116
Research Plan | |
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Research case data | |
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