UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000750 |
|---|---|
| Receipt number | R000000905 |
| Scientific Title | Observational Registry:Gastrointestinal Complications developed during low-dose aspirin intake or atherothrombosis such as myocardial infarction and cerebral infarction- |
| Date of disclosure of the study information | 2007/07/01 |
| Last modified on | 2016/06/27 10:15:12 |
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Basic information
Public title
Observational Registry:Gastrointestinal Complications developed during low-dose aspirin intake or atherothrombosis such as myocardial infarction and cerebral infarction-
Acronym
Management of Aspirin-induced Gastrointestinal Complications (MAGIC)
Scientific Title
Observational Registry:Gastrointestinal Complications developed during low-dose aspirin intake or atherothrombosis such as myocardial infarction and cerebral infarction-
Scientific Title:Acronym
Management of Aspirin-induced Gastrointestinal Complications (MAGIC)
Region
| Japan |
Condition
Condition
Cerebral infarction, TIA, angina, myocardial infarction, atrial fibrillation
Classification by specialty
| Medicine in general | Gastroenterology | Cardiology |
| Neurology | Geriatrics | Surgery in general |
| Vascular surgery | Neurosurgery | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the Incidence of aspirin-induced upper gastrointestinal complications and their risk factors in Japanese
Basic objectives2
Others
Basic objectives -Others
Observational Registry: Incidence of aspirin-induced upper gastrointestinal complications
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Findings of ulcer, and erosion in upper GI under endoscopy
Key secondary outcomes
Event rate: GI hemorrhage and alternative LANZA score (stomach), Cerebral hemorrhage, Other systematic hemorrhage, cardiovascular death, nonfatal MI, nonfatal cerebrovascular infarction, TIA, Coronary angioplasty /STENT insertion, worsening of primary disease
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cerebrovascular disease (cerebral infarction, TIA et al), Coronary heart disease(angina,Myocardial infarction et al), Atrial fibrillation With 1)20 years-old or older, 2) Asprin intake under 330mg as daily dose for 1 month or more, 3) Outpatients
Key exclusion criteria
1) Serious hepatic or renal disorder with treatment required, 2)Serious lung disorder with treatment required, 3)Pregnant, Possible pregnant, Pregnant desired, 4) Uncontrolled DM, 5)Cancer patient with treatment required, 6)Patient experienced surgery for esophagus, stomach, and duodenal disease, 7)Patient having hypersensitivity against aspirin or other salicylic acids, 8)Patient whom the investigator determined as inadequate
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Ikeda |
Organization
Keio University School of Medicine
Division name
Department of Medicine
Zip code
Address
Shinanomachi 35 Shinjyuku-ku Tokyo
TEL
03-3353-1211
yikeda37@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinya Goto |
Organization
Tokai University School of Medicine
Division name
Department of Medicine
Zip code
Address
143 Shimokasuya, Isehara, Kanagawa 259-1143, Japan
TEL
0463-93-1121
Homepage URL
http://www.magic_trail.com
shinichi@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Society for the MAGIC
Institute
Department
Personal name
Funding Source
Organization
Japan Cardiovascular Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
N/A
Name of secondary funder(s)
N/A
IRB Contact (For public release)
Organization
Address
Tel
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
自治医科大学附属病院 群馬
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.ncbi.nlm.nih.gov/pubmed/21842134
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/23754512
Number of participants that the trial has enrolled
Results
Gastroduodenal ulcer and erosion were detected in 6.5, and 29.2% of the 1,454 patients receiving aspirin, respectively. H
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
Main results already published
Date of protocol fixation
| 2004 | Year | 11 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
So far, no preliminary data is available. We are trying clarify the real incidence of aspirin-induced upper gastric ulcer. We are also trying clarify the contributing role of cardiovascular risk factors in the onset of aspirin-induced ulcer formaton.
Management information
Registered date
| 2007 | Year | 06 | Month | 26 | Day |
Last modified on
| 2016 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000905
| 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 |
