UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045210 |
|---|---|
| Receipt number | R000051238 |
| Scientific Title | Benefits and risks aSsessment of DOAC initiation in AF patients Early post IntraCranial Hemorrhage from Japan |
| Date of disclosure of the study information | 2021/08/20 |
| Last modified on | 2023/08/25 14:52:23 |
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Basic information
Public title
Benefits and risks aSsessment of DOAC initiation in AF patients Early post IntraCranial Hemorrhage from Japan
Acronym
SAFE-ICH
Scientific Title
Benefits and risks aSsessment of DOAC initiation in AF patients Early post IntraCranial Hemorrhage from Japan
Scientific Title:Acronym
SAFE-ICH
Region
| Japan |
Condition
Condition
Patients with symptomatic intracranial hemorrhage (ICH) and non-valvular atrial fibrillation (NVAF)
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the incidences of hemorrhagic and thrombotic events after early direct oral anticoagulant (DOAC) initiation in patients with NVAF who are scheduled to resume/initiate DOAC within 14 days from ICH in a prospective observational study
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Composite of these incidence rates up to 30 days after ICH
- Symptomatic ICH
- Symptomatic stroke
- All-cause death
Key secondary outcomes
1) Incidence rates of the following individual events up to 48 hours of DOAC administration (assessed by imaging)
- Asymptomatic cerebral infarction
- Asymptomatic ICH
- Hematoma expansion (percentage of enlarged cases, central evaluation using CT images)
2) Incidence rates of the following individual events up to 30 days of DOAC administration
- Symptomatic ICH
- Symptomatic stroke
- Symptomatic ischemic stroke
- Symptomatic intraparenchymal hemorrhage
- Systemic embolism
- Major bleeding
- All-cause death
- Hematoma expansion (percentage of enlarged cases, central evaluation using CT images)
3) Incidence of the following composite events up to 3 and 12 months of DOAC administration
- Symptomatic ICH
- Symptomatic stroke
- All-cause death
4) Incidence of individual events up to 3 and 12 months of DOAC administration
- Symptomatic ICH
- Symptomatic stroke
- Symptomatic ischemic stroke
- Symptomatic intraparenchymal hemorrhage
- Systemic embolism
- Major bleeding
- All-cause death
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) With symptomatic ICH (*See below)
2) Given the definitive diagnosis of NVAF and who are scheduled to resume/are resumed DOAC within 14 days after ICH occurrence
3) Obtaining written informed consent from the patient or his/her representative
4) Age >= 20 years at the time of signing the informed consent
- Eligibility of patients with different subtypes of ICH
1. Intrinsic (intraparenchymal hemorrhage, intraventricular hemorrhage, acute epidural hematoma, acute subdural hematoma): Eligible
2. Traumatic (intraparenchymal hemorrhage, intraventricular hemorrhage, acute epidural hematoma, acute subdural hematoma): Eligible
3. Amyloid angiopathy (intraparenchymal hemorrhage, intraventricular hemorrhage): Eligible
Key exclusion criteria
1) ICH caused by diagnosed vascular lesions such as cerebral aneurysm, cerebral arteriovenous malformation, cavernous hemangioma, dural arteriovenous fistula, cerebral venous vascular malformation, cerebral venous sinus thrombosis, and neoplastic or infectious
2) Patients with aneurysmal subarachnoid hemorrhage and traumatic subarachnoid hemorrhage without subdural or intracerebral hematoma, and patients with chronic subdural hematoma
3) Patients with a history of ICH within the past 3 months of current ICH onset
4) Patients with pre-morbid modified Rankin Scale of 5
5) Patients planning left atrial appendage closure treatment
6) Patients who meet the contraindications for each DOAC within 14 days of ICH onset
7) Patients requiring continuous oral anticoagulation for other diseases than AF (e.g., venous thromboembolism)
8) Patients who experienced a primary endpoint event specified in this study before informed consent
9) Pregnant or breastfeeding patients
10) Patients with an estimated life expectancy of less than 6 months at enrollment
11) Patients who are currently participating or scheduled to participate in clinical trials and intervention studies
12) Patients who are deemed inappropriate to participate in this study at the discretion of the physician in charge
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Masatoshi |
| Middle name | |
| Last name | Koga |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Cerebrovascular Medicine
Zip code
564-8565
Address
6-1 Kishibe-Shimmachi, Suita, Osaka
TEL
06-6170-1070
koga@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Masatoshi |
| Middle name | |
| Last name | Koga |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Cerebrovascular Medicine
Zip code
564-8565
Address
6-1 Kishibe-Shimmachi, Suita, Osaka
TEL
06-6170-1070
Homepage URL
koga@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Department of Cerebrovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
Primary Medical Science Department
Medical Affairs Div.
Daiichi Sankyo Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, National Cerebral and Cardiovascular Center
Address
6-1 Kishibe-Shimmachi, Suita, Osaka
Tel
06-6170-1070
rec-office-ac@ncvc.go.jp
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
帯広厚生病院（北海道）/ Obihiro Kosei Hospital (Hokkaido)
弘前脳卒中・リハビリテーションセンター（青森県）/ Hirosaki Stroke and Rehabilitation Center (Aomori Prefecture)
岩手医科大学附属病院（岩手県）/ Iwate Medical University Hospital (Iwate Prefecture)
岩手県立中央病院（岩手県）/ Iwate Prefectural Central Hospital (Iwate Prefecture)
山形県立中央病院（山形県）/ Yamagata Prefectural Central Hospital (Yamagata Prefecture)
自治医科大学附属病院（栃木県）/ Jichi Medical University Hospital (Tochigi Prefecture)
東京慈恵会医科大学附属病院（東京都）/ The Jikei University Hospital (Tokyo)
杏林大学医学部付属病院（東京都）/ Kyorin University Hospital (Tokyo)
国立循環器病研究センター（大阪府）/ National Cerebral and Cardiovascular Center (Osaka Prefecture)
関西医科大学附属病院（大阪府）/ Kansai Medical University Hospital (Osaka Prefecture)
神戸市立医療センター中央市民病院（兵庫県）/ Kobe City Medical Center General Hospital (Hyogo Prefecture)
大西脳神経外科病院（兵庫県）/ Ohnishi Neurological Center (Hyogo Prefecture)
徳島大学病院（徳島県）/ Tokushima University Hospital (Tokushima Prefecture)
熊本市民病院（熊本県）/ Kumamoto City Hospital (Kumamoto Prefecture)
熊本赤十字病院（熊本県）/ Japanese Red Cross Kumamoto Hospital (Kumamoto Prefecture)
済生会熊本病院（熊本県）/ Saiseikai Kumamoto Hospital (Kumamoto Prefecture)
小倉記念病院（福岡県）/ Kokura Memorial Hospital(Fukuoka Prefecture)
武蔵野赤十字病院（東京都）/ Japanese Red Cross Musashino Hospital（Tokyo）
山形市立病院済生館（山形県）/ Yamagata City Hospital Saiseikan(Yamagata Prefecture)
日本医科大学付属病院（東京都）/ Nippon Medical School Hospital(Tokyo)
聖マリアンナ医科大学 東横病院（神奈川県） / St. Marianna University Toyoko Hospital(Kanagawa Prefecture)
大阪医療センター（大阪府）/ National Hospital Organization Osaka National Hospital(Osaka Prefecture)
福岡県済生会福岡総合病院（福岡県）/ Saiseikai Fukuoka General Hospital(Fukuoka Prefecture)
製鉄記念八幡病院（福岡県）/ Steel Memorial Yawata Hospital(Fukuoka Prefecture)
鹿児島市立病院（鹿児島県）/ Kagoshima City Hospital(Kagoshima Prefecture)
トヨタ記念病院（愛知県）/ Toyota Memorial Hospital(Aichi Prefecture)
京都第二赤十字病院（京都府）/ Japanese Red Cross Kyoto Daini Hospital(Kyoto Prefecture)
中村記念病院（北海道） / Nakamura Memorial Hospital(Hokkaido)
岐阜大学医学部附属病院（岐阜県）/ Gifu University Hospital(Gifu Prefecture)
広南病院（宮城県） / Kohnan Hospital(Miyagi Prefecture)
脳神経センター大田記念病院（広島県）/ Brain Attack Center Ota Memorial Hospital(Hiroshima Prefecture)
倉敷中央病院（岡山県）/ Kurashiki Central Hospital(Okayama Prefecture)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter, Prospective, Observational Study
Management information
Registered date
| 2021 | Year | 08 | Month | 20 | Day |
Last modified on
| 2023 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051238
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
