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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002460
Receipt No. R000003012
Scientific Title Management of gastrointestinal complications in patients undertaking low-dose aspirin after percutaneous coronary interventions (PCI)
Date of disclosure of the study information 2009/09/08
Last modified on 2012/03/07

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Basic information
Public title Management of gastrointestinal complications in patients undertaking low-dose aspirin after percutaneous coronary interventions (PCI)
Acronym LA-study
Scientific Title Management of gastrointestinal complications in patients undertaking low-dose aspirin after percutaneous coronary interventions (PCI)
Scientific Title:Acronym LA-study
Region
Japan

Condition
Condition In patient underwent PCI, low-dose aspirin undertaking for 6 months or more for the prevention of restenosis
Classification by specialty
Gastroenterology Cardiology Geriatrics
Vascular surgery Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To indicate the effect of PPI or H2recepter antagonist for prevention of gastrointestinal complications on post-PCI patients undertaking low-dose aspirin
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Efficacy:Incidence of gastrointestinal complications based on post-6-month
Safety:Adverse events for 6 months
Key secondary outcomes 1.Incidence of gastrointestinal hemorrhage and/or ulcer in patients with previous gastrointestinal ulcer, 2. Incidence ofgastrointestinal hemorrhage and/or ulcer in patients with 65 years old or more, 3.Infection rate with H. pylori, 4.Inprovement rate of gastrointestinal complications after 6 months treatment of dieretic agent


Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 PPI
Interventions/Control_2 H2RA
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
85 years-old >=
Gender Male and Female
Key inclusion criteria (1)Available for low-dose aspirin successive treatments for 6 months or more
(2)Age 25<= to 85>=
(3)Out patients
(4)Sufficient communication with investigators or physicians
Key exclusion criteria (1)Hypersinsitivity for any drugs
(2)Patient undertaking atazanavir sulfate
(3)Patient with severe hepatic and/or renal disorders required any therapy
(4)Patient with severe heart and/or lung disorders required any therapy
(5)Pregnancy, possible pregnancy, or pregnancy hopeful
(6)Upper gastrointestinal disorders (ulcer with hemrrhage, erosion unknown upper gastrointestinal hemmorhage
(7)PPI taken with past 3 months
(8)Patient with malignant neoplasm
(9)Patient with surgery at esophagas duodenal and/or stomach
(10)Perticipant in any other clinical trials within past 1 month
(11)Patient whom investigators/physicins assessed inappropriate as a participant
Target sample size 360

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyoshi Yokoi
Organization Kokura Memorial Hospital
Division name Cardiology
Zip code
Address 1-1, Kifune-cho, Kokurakitaku, Kitakyushu, Fukuoka Pf, Japan
TEL 093-921-2231
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroko Usami
Organization BAIMEDIS INTERNATIONL Ltd
Division name Study Management Group
Zip code
Address ASK Bld 4F 7-10-6, Ginza, Chuo-ku, Tokyo, 104-0061, Japan
TEL 03-3575-1611
Homepage URL
Email hiroko-u@biomedis.co.jp

Sponsor
Institute Stearing committee for LA-Study
Institute
Department

Funding Source
Organization Japan Cardiovascular Research Fundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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 小倉記念病院 など4施設 (福岡県)

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 08 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 Enrolling by invitation
Date of protocol fixation
2008 Year 09 Month 26 Day
Date of IRB
Anticipated trial start date
2008 Year 10 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 09 Month 07 Day
Last modified on
2012 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003012

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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