SAMURAI-NVAF Study: Anticoagulant Therapy for Japanese Stroke Patients With Nonvalvular Atrial Fibrillation (NVAF)
This study is currently recruiting participants.
Verified April 2012 by Ministry of Health, Labour and Welfare, Japan
Sponsor:
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Kazunori Toyoda, Ministry of Health, Labour and Welfare, Japan
ClinicalTrials.gov Identifier:
NCT01581502
First received: April 16, 2012
Last updated: April 18, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Stroke, Acute Atrial Fibrillation |
Other: This is an observational study. |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Stroke Acute Management With Urgent Risk-factor Assessment and Improvement (SAMURAI) Study on Anticoagulant Therapy in Nonvalvular Atrial Fibrillation (NVAF) |
Resource links provided by NLM:
Further study details as provided by Ministry of Health, Labour and Welfare, Japan:
Primary Outcome Measures:
- Ischemic events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Recurrence of ischemic stroke/TIA, ACS, systemic embolism, aortic dissection, rupture of aortic aneurysm, peripheral artery disease (required hospitalization), VTE, revascularization (including CEA/CAS, PCI, etc)
- major bleeding [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Major bleeding according to the ISTH definition, including fatal bleeding, intracranial hemorrhage, etc
Secondary Outcome Measures:
- modified Rankin Scale [ Time Frame: 2 years ] [ Designated as safety issue: No ]modified Rankin Scale
- Modification of anticoagulant medication [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | December 2015 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
NVAF, acute ischemic stroke/TIA
Consecutive acute ischemic stroke/TIA patients with nonvalvular atrial fibrillation; most of these patients begin to receive anticoagulant therapy after index stroke/TIA for secondary prevention
|
Other: This is an observational study.
This is an observational, not intervention, study.
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
inpatients
Criteria
Inclusion Criteria:
- Consecutive acute ischemic stroke/TIA patients with NVAF
Exclusion Criteria:
- Rheumatic mitral valve disease
- A history of prosthetic valve replacement or mitral valve surgical repair
- Active infective endocarditis
- Patient, family member or legally responsible person does not have given informed consent
- Inappropriate patient's conditions for study enrollment in the opinion of the investigator
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581502
Contacts
| Contact: Shoji Arihiro, MD | sarihiro@hsp.ncvc.go.jp |
Locations
| Japan | |
| National Hospital Organization Nagoya Medical Center | Recruiting |
| Nagoya, Aichi, Japan | |
| Contact: Satoshi Okuda, MD | |
| Principal Investigator: Satoshi Okuda, MD | |
| Toyota Memorial Hospital | Recruiting |
| Toyota, Aichi, Japan | |
| Contact: Yasuhiro Itoh, MD | |
| Principal Investigator: Yasuhiro Itoh, MD | |
| Brain Attack Center Ota Memorial Hospital | Recruiting |
| Fukuyama, Hiroshima, Japan | |
| Contact: Kazuhiro Takamatsu, MD | |
| Principal Investigator: Kazuhiro Takamatsu, MD | |
| Nakamura Memorial Hospital | Recruiting |
| Sapporo, Hokkaido, Japan | |
| Contact: Jyoji Nakagawara, MD | |
| Principal Investigator: Jyoji Nakagawara, MD | |
| Kobe City Medical Center General Hospital | Recruiting |
| Kobe, Hyogo, Japan | |
| Contact: Kenichi Todo, MD | |
| Principal Investigator: Kenichi Todo, MD | |
| St Marianna University School of Medicine | Recruiting |
| Kawasaki, Kanagawa, Japan | |
| Contact: Yasuhiro Hasegawa, MD | |
| Principal Investigator: Yasuhiro Hasegawa, MD | |
| South Miyagi Medical Center | Recruiting |
| Ogawara, Miyagi, Japan | |
| Contact: Hiroshi Mochizuki, MD | |
| Principal Investigator: Hiroshi Mochizuki, MD | |
| Kohnan Hospital | Recruiting |
| Sendai, Miyagi, Japan | |
| Contact: Eisuke Furui, MD | |
| Principal Investigator: Eisuke Furui, MD | |
| Kawasaki Medical School | Recruiting |
| Kurashiki, Okayama, Japan | |
| Contact: Kazumi Kimura, MD | |
| Principal Investigator: Kazumi Kimura, MD | |
| National Cerebral and Cardiovascular Center | Recruiting |
| Suita, Osaka, Japan, 565-8565 | |
| Principal Investigator: Kazunori Toyoda, MD | |
| Sub-Investigator: Hiroshi Yamagami, MD | |
| Sub-Investigator: Masatoshi Koga, MD | |
| Jichi Medical University School of Medicine | Recruiting |
| Shimotsuke, Tochigi, Japan | |
| Contact: Kazuomi Kario, MD | |
| Principal Investigator: Kazuomi Kario, MD | |
| Kyorin University School of Medicine | Recruiting |
| Mitaka, Tokyo, Japan | |
| Contact: Yshiaki Shiokawa, MD | |
| Principal Investigator: Yshiaki Shiokawa, MD | |
| National Hospital Organization Kyushu Medical Center | Recruiting |
| Fukuoka, Japan | |
| Contact: Yasushi Okada, MD | |
| Principal Investigator: Yasushi Okada, MD | |
| National Hospital Organization Kagoshima Medical Center | Recruiting |
| Kagoshima, Japan | |
| Contact: Takahiro Nakashima, MD | |
| Principal Investigator: Takahiro Nakashima, MD | |
| Japanese Red Cross Kumamoto Hospital | Recruiting |
| Kumamoto, Japan | |
| Contact: Tadashi Terasaki, MD | |
| Principal Investigator: Tadashi Terasaki, MD | |
| Japanese Red Cross Kyoto Daini Hospital | Recruiting |
| Kyoto, Japan | |
| Contact: Yoshinari Nagakane, MD | |
| Principal Investigator: Yoshinari Nagakane, MD | |
Sponsors and Collaborators
Ministry of Health, Labour and Welfare, Japan
Investigators
| Principal Investigator: | Kazunori Toyoda, MD | SAMURAI Study Investigators |
More Information
Additional Information:
No publications provided
| Responsible Party: | Kazunori Toyoda, National Cerebral and Cardiovascular Center, Ministry of Health, Labour and Welfare, Japan |
| ClinicalTrials.gov Identifier: | NCT01581502 History of Changes |
| Other Study ID Numbers: | samurai2011, samurai nvaf 2011 |
| Study First Received: | April 16, 2012 |
| Last Updated: | April 18, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Ministry of Health, Labour and Welfare, Japan:
|
Anticoagulation Recurrent stroke Bleeding |
Additional relevant MeSH terms:
|
Atrial Fibrillation Stroke Cerebral Infarction Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Brain Infarction Brain Ischemia Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013