UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003264 |
|---|---|
| Receipt number | R000001831 |
| Scientific Title | Serial endoscopic evaluation of aspirin-induced gastroduodenal injury: pevention of peptic ulcer with proton pump inhibitor in patients taking low-dose aspirin |
| Date of disclosure of the study information | 2010/02/28 |
| Last modified on | 2011/09/28 16:11:24 |
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Basic information
Public title
Serial endoscopic evaluation of aspirin-induced gastroduodenal injury: pevention of peptic ulcer with proton pump inhibitor in patients taking low-dose aspirin
Acronym
SEND-AGI study
Scientific Title
Serial endoscopic evaluation of aspirin-induced gastroduodenal injury: pevention of peptic ulcer with proton pump inhibitor in patients taking low-dose aspirin
Scientific Title:Acronym
SEND-AGI study
Region
| Japan |
Condition
Condition
Coronay artery disase
Gastroduodenal ulcer
Classification by specialty
| Gastroenterology | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the preventive effect of proton pump inhibitor against gastroduodenal mucosal injuty with a prospective, randomized, double-blinded, placebo-controlled study in patients taking aspirin after percutaneous coronary stent implantation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Gastroduodenal Ulcer or bleeding, Upper Gastrointestinal symptom and decrease in hemoglobin level 3 month after percutaneous coronary intervention
Key secondary outcomes
Severity of gastroduodenal mucosal injury evaluated with LANZA score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Raveprazole (10 mg) will be given for 3 months in patinets who undergo PCI and take aspirin, after confirming the absence of endoscopic upper GI ulcer.
Interventions/Control_2
Placebo will be given for 3 months in patinets who undergo PCI and take aspirin, after confirming the absence of endoscopic upper GI ulcer.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with Coronary artery disease
Patients who underwent Percutaneous coronary intervention using coronary stent
Patinets who were treated with anti-platelets including aspirin
Key exclusion criteria
Patients having an episode of adverse effect by rabeprazole or other proton pump inhibitor
Patients with severe liver or renal dysfunction
Patients with NYHA III or IV heart failure
Patients with pregnancy (including possible), or nursing patients
Patients who are not judged to be appropreate by a study conductor
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kyoichi Mizuno |
Organization
Nippon Medical School
Division name
Department of Medicine
Zip code
Address
1-1-5, Sendagi, Bunkyo, Tokyo, Japan
TEL
03-3822-2131
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Takano |
Organization
Nippon Medical School
Division name
Department of Medicine
Zip code
Address
TEL
Homepage URL
htakano@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
日本医科大学付属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 02 | Month | 28 | 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
Terminated
Date of protocol fixation
| 2008 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 28 | Day |
Last modified on
| 2011 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001831
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| Registered date | File name |
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| Registered date | File name |
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