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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000000750
Receipt No. 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

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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
Email 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
Email shinichi@is.icc.u-tokai.ac.jp

Sponsor
Institute Society for the MAGIC
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000905

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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