UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003385 |
|---|---|
| Receipt number | 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 | 2022/01/27 18:40:24 |
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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
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
541-8505
Address
3-2-10 Doshi-machi, Chuoh-ku, Osaka-shi, Osaka 541-8505, Japan
TEL
06-6205-5842
Homepage URL
season@cc.mt-pharma.co.jp
Sponsor or person
Institute
Mitsubishi Tanabe Pharma Corporation
Institute
Department
Personal name
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
-
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.
-Circ J. 83(9):1029-36,2019.
<Scientific Conference>
-The Annual Meeting of Japanese College of Angiology
53rd (2012)
54th (2013)
55th (2014)
-The Annual Scientific Meeting of the Japanse Curculation Society
77th (2013)
78th (2014)
79th (2015)
-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
| 2022 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004111
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| Registered date | File name |
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