UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002460 |
|---|---|
| Receipt number | 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 10:12:12 |
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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
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
hiroko-u@biomedis.co.jp
Sponsor or person
Institute
Stearing committee for LA-Study
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003012
