UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observational Registry:Gastrointestinal Complications developed during low-dose aspirin intake or atherothrombosis such as myocardial infarction and cerebral infarction-
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Yasuo Ikeda
Organization	Keio University School of Medicine
Division name	Department of Medicine
Address	Shinanomachi 35 Shinjyuku-ku Tokyo
TEL	03-3353-1211
Email	yikeda37@gmail.com

Public contact
Name of contact person	Shinya Goto
Organization	Tokai University School of Medicine
Division name	Department of Medicine
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2004 Year 11 Month 20 Day
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

Related information
URL releasing protocol	http://www.ncbi.nlm.nih.gov/pubmed/21842134
Publication of results	Published
URL releasing results	http://www.ncbi.nlm.nih.gov/pubmed/23754512
Results	Gastroduodenal ulcer and erosion were detected in 6.5, and 29.2% of the 1,454 patients receiving aspirin, respectively. H
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/icdr_e/ctr_view.cgi?recptno=R000000905