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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003264
Receipt No. 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

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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
Email

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
Email htakano@nms.ac.jp

Sponsor
Institute Nippon Medical School
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001831

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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