Clinical trial NCT01581502: SAMURAI-NVAF Study: Anticoagulant Therapy for Japanese Stroke Patients With Nonvalvular Atrial Fibrillation (NVAF)
Official title: Stroke Acute Management With Urgent Risk-factor Assessment and Improvement (SAMURAI) Study on Anticoagulant Therapy in Nonvalvular Atrial Fibrillation (NVAF)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke, Acute
Atrial Fibrillation
Keywords: Anticoagulation
Recurrent stroke
Bleeding
Lead sponsor: Ministry of Health, Labour and Welfare, Japan
Sponsor class: OTHER_GOV
First posted: 2012-04-20
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: inpatients

Brief summary: The purpose of this study is to determine choice of anticoagulant therapy during acute and chronic stages of ischemic stroke/TIA and short- and long-term outcomes, including stroke recurrence and bleeding complications, in patients having nonvalvular atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

* Consecutive acute ischemic stroke/TIA patients with NVAF

Exclusion Criteria:

1. Rheumatic mitral valve disease
2. A history of prosthetic valve replacement or mitral valve surgical repair
3. Active infective endocarditis
4. Patient, family member or legally responsible person does not have given informed consent
5. Inappropriate patient's conditions for study enrollment in the opinion of the investigator

Primary outcomes:
measure: Ischemic events
timeFrame: 2 years
measure: major bleeding
timeFrame: 2 years
Secondary outcomes:
measure: modified Rankin Scale
timeFrame: 2 years
measure: Modification of anticoagulant medication
timeFrame: 2 years
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center
state: Aichi
city: Toyota
country: Japan
facility: Toyota Memorial Hospital
state: Aichi
city: Fukuyama
country: Japan
facility: Brain Attack Center Ota Memorial Hospital
state: Hiroshima
city: Sapporo
country: Japan
facility: Nakamura Memorial Hospital
state: Hokkaido
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Kawasaki
country: Japan
facility: St Marianna University School of Medicine
state: Kanagawa
city: Ogawara
country: Japan
facility: South Miyagi Medical Center
state: Miyagi
city: Sendai
country: Japan
facility: Kohnan Hospital
state: Miyagi
city: Kurashiki
country: Japan
facility: Kawasaki Medical School
state: Okayama
city: Suita
country: Japan
facility: National Cerebral and Cardiovascular Center
state: Osaka
city: Shimotsuke
country: Japan
facility: Jichi Medical University School of Medicine
state: Tochigi
city: Mitaka
country: Japan
facility: Kyorin University School of Medicine
state: Tokyo
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Kagoshima
country: Japan
facility: National Hospital Organization Kagoshima Medical Center
city: Kumamoto
country: Japan
facility: Japanese Red Cross Kumamoto Hospital
city: Kyoto
country: Japan
facility: Japanese Red Cross Kyoto Daini Hospital
Study officials:
affiliation: SAMURAI Study Investigators
name: Kazunori Toyoda, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Toyoda K, Arihiro S, Todo K, Yamagami H, Kimura K, Furui E, Terasaki T, Shiokawa Y, Kamiyama K, Takizawa S, Okuda S, Okada Y, Kameda T, Nagakane Y, Hasegawa Y, Mochizuki H, Ito Y, Nakashima T, Takamatsu K, Nishiyama K, Kario K, Sato S, Koga M; SAMURAI Study Investigators. Trends in oral anticoagulant choice for acute stroke patients with nonvalvular atrial fibrillation in Japan: the SAMURAI-NVAF study. Int J Stroke. 2015 Aug;10(6):836-42. doi: 10.1111/ijs.12452. Epub 2015 Jan 12.
citation: Toyoda K. Is anticoagulant therapy unnecessary for lower-risk Japanese patients with atrial fibrillation? Lessons from the SAMURAI-NVAF and BAT studies. Circ J. 2015;79(2):307-9. doi: 10.1253/circj.CJ-14-1350. Epub 2014 Dec 24. No abstract available.
citation: Tanaka K, Miwa K, Takagi M, Sasaki M, Yakushiji Y, Kudo K, Shiozawa M, Tanaka J, Nishihara M, Yamaguchi Y, Fujita K, Honda Y, Kawano H, Ide T, Yoshimura S, Koga M, Hirano T, Toyoda K. Increased Cerebral Small Vessel Disease Burden With Renal Dysfunction and Albuminuria in Patients Taking Antithrombotic Agents: The Bleeding With Antithrombotic Therapy 2. J Am Heart Assoc. 2022 Mar 15;11(6):e024749. doi: 10.1161/JAHA.121.024749. Epub 2022 Mar 5.
citation: Tanaka K, Koga M, Lee KJ, Kim BJ, Mizoguchi T, Park EL, Lee J, Yoshimura S, Cha JK, Lee BC, Koge J, Bae HJ, Toyoda K; CRCS-K Investigators, the SAMURAI Study Investigators. Transesophageal Echocardiography in Ischemic Stroke With Atrial Fibrillation. J Am Heart Assoc. 2021 Nov 16;10(22):e022242. doi: 10.1161/JAHA.121.022242. Epub 2021 Nov 6.
citation: Tanaka K, Koga M, Lee KJ, Kim BJ, Park EL, Lee J, Mizoguchi T, Yoshimura S, Cha JK, Lee BC, Nakahara J, Suzuki N, Bae HJ, Toyoda K; CRCS-K Investigators and the SAMURAI Study Investigators. Atrial Fibrillation-Associated Ischemic Stroke Patients With Prior Anticoagulation Have Higher Risk for Recurrent Stroke. Stroke. 2020 Apr;51(4):1150-1157. doi: 10.1161/STROKEAHA.119.027275. Epub 2020 Feb 26.
citation: Mizoguchi T, Tanaka K, Toyoda K, Yoshimura S, Itabashi R, Takagi M, Todo K, Shiozawa M, Yagita Y, Yoshimoto T, Terasaki T, Yamagami H, Takizawa S, Inoue M, Kamiyama K, Ihara M, Okada Y, Kitazono T, Koga M; SAMURAI Study Investigators. Early Initiation of Direct Oral Anticoagulants After Onset of Stroke and Short- and Long-Term Outcomes of Patients With Nonvalvular Atrial Fibrillation. Stroke. 2020 Mar;51(3):883-891. doi: 10.1161/STROKEAHA.119.028118. Epub 2020 Jan 22.
citation: Tokunaga K, Koga M, Itabashi R, Yamagami H, Todo K, Yoshimura S, Kimura K, Sato S, Terasaki T, Inoue M, Shiokawa Y, Takagi M, Kamiyama K, Tanaka K, Takizawa S, Shiozawa M, Okuda S, Okada Y, Kameda T, Nagakane Y, Hasegawa Y, Shibuya S, Ito Y, Matsuoka H, Takamatsu K, Nishiyama K, Kario K, Yagita Y, Fujita K, Ando D, Kumamoto M, Arihiro S, Toyoda K; SAMURAI Study Investigators. Prior Anticoagulation and Short- or Long-Term Clinical Outcomes in Ischemic Stroke or Transient Ischemic Attack Patients With Nonvalvular Atrial Fibrillation. J Am Heart Assoc. 2019 Feb 5;8(3):e010593. doi: 10.1161/JAHA.118.010593.
citation: Koga M, Yoshimura S, Hasegawa Y, Shibuya S, Ito Y, Matsuoka H, Takamatsu K, Nishiyama K, Todo K, Kimura K, Furui E, Terasaki T, Shiokawa Y, Kamiyama K, Takizawa S, Okuda S, Okada Y, Kameda T, Nagakane Y, Yagita Y, Kario K, Shiozawa M, Sato S, Yamagami H, Arihiro S, Toyoda K; SAMURAI Study Investigators. Higher Risk of Ischemic Events in Secondary Prevention for Patients With Persistent Than Those With Paroxysmal Atrial Fibrillation. Stroke. 2016 Oct;47(10):2582-8. doi: 10.1161/STROKEAHA.116.013746. Epub 2016 Aug 16.