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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000003385
Receipt No. R000004111
Scientific Title A prospective surveillance of cardiovascular events in antiplatelet-treated arteriosclerosis obliterans patients in Japan.
Date of disclosure of the study information 2010/03/26
Last modified on 2019/06/12

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Basic information
Public title A prospective surveillance of cardiovascular events in antiplatelet-treated arteriosclerosis obliterans patients in Japan.
Acronym SEASON
Scientific Title A prospective surveillance of cardiovascular events in antiplatelet-treated arteriosclerosis obliterans patients in Japan.
Scientific Title:Acronym SEASON
Region
Japan

Condition
Condition Arteriosclerosis obliterans
Peripheral arterial disease
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Vascular surgery Orthopedics Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objectives of the study are to determine the prognosis of ASO patients receiving antiplatelet therapy, to explore the relationships between prognosis and the characteristics and risk factors of patients, and to compare the effectiveness of sarpogrelate in decreasing the event rate with those of other antiplatelet agents.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Combined endpoint comprised of the following cardiovascular events;
- Cerebrovascular events
- Cardiovascular events
- Peripheral vascular events
Key secondary outcomes Cerebrovascular events
Cardiovascular events
Peripheral vascular events
Total cardiovascular death
Fatal cerebrovascular events
Fatal cardiovascular events
Fatal peripheral vascular events
All causes of death
Amputation
Development of critical limb ischemia

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

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who meet both of the following criteria (1) and (2):
(1)Diagnosed with ASO and scheduled to receive long-term oral antiplatelet therapy.
(2)Not receiving sarpogrelate at the time of registration and meeting either of the following conditions:
- Scheduled to receive one of the antiplatelet agents under study.
- Scheduled to change to sarpogrelate or one of the other oral antiplatelet agents under study or receive it in addition to antiplatelet therapy.
Key exclusion criteria The following subjects were excluded:
(1)Those with contraindications to the use of targeted medication (sarpogrelate or antiplatelet agents).
(2)Those considered inappropriate for the study by patient's physicians.
Target sample size 10000

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Shigematsu
Organization International University of Health and Welfare
SANNO Medical Center
Division name Vascular Disease Center
Zip code 107-0052
Address 8-5-35 Akasaka, Minato-ku, Tokyo 107-0052, JAPAN
TEL 03-3402-5581
Email season@cc.mt-pharma.co.jp

Public contact
Name of contact person
1st name Masahide
Middle name
Last name Nakajima
Organization Mitsubishi Tanabe Pharma Corporation
Division name Pharmacovigilance Coordination & Administration Department
Zip code 532-8505
Address 3-16-89 Kajima, Yodogawa-ku, Osaka-shi, Osaka 532-8505, Japan
TEL 06-6300-2704
Homepage URL
Email season@cc.mt-pharma.co.jp

Sponsor
Institute Mitsubishi Tanabe Pharma Corporation
Institute
Department

Funding Source
Organization Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization -
Address -
Tel -
Email season@cc.mt-pharma.co.jp

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

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 26 Day

Related information
URL releasing protocol http://www.readcube.com/articles/10.1253%2Fcircj.CJ-15-1048
Publication of results Partially published

Result
URL related to results and publications http://www.readcube.com/articles/10.1253%2Fcircj.CJ-15-1048
Number of participants that the trial has enrolled 11375
Results
<Journal Articles>
-Int Heart J. 51(5):337-42,2010.
-Circ J. 80(3):712-21,2016.
-Scientific Reports 7(1):6095,2017. 
-Angiology Nov26,2018.

<Scientific Conference>
-European Society of Cardiology (2015)
Results date posted
2019 Year 03 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2016 Year 02 Month 04 Day
Baseline Characteristics
Circ J. 80(3):712-21,2016.
Participant flow
Scientific Reports 7(1):6095,2017. 
Adverse events
Not applicable.
Outcome measures
Scientific Reports 7(1):6095,2017. 
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2009 Year 06 Month 05 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2013 Year 09 Month 01 Day
Date of closure to data entry
2014 Year 06 Month 13 Day
Date trial data considered complete
2014 Year 10 Month 07 Day
Date analysis concluded
2016 Year 06 Month 23 Day

Other
Other related information The SEASON registry is a nationwide observational prospective cohort study with a two-year period of follow-up.

Management information
Registered date
2010 Year 03 Month 26 Day
Last modified on
2019 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004111

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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