UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013630 |
|---|---|
| Receipt number | R000015909 |
| Scientific Title | Prospective study of treatment for elderly patients with PAD (peripheral arterial disease) using Propensity Score Analysis |
| Date of disclosure of the study information | 2014/05/01 |
| Last modified on | 2014/04/04 13:39:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prospective study of treatment for elderly patients with PAD (peripheral arterial disease) using Propensity Score Analysis
Acronym
Prospective study about treatment for elderly patients with PAD (peripheral arterial disease)
Scientific Title
Prospective study of treatment for elderly patients with PAD (peripheral arterial disease) using Propensity Score Analysis
Scientific Title:Acronym
Prospective study about treatment for elderly patients with PAD (peripheral arterial disease)
Region
| Japan |
Condition
Condition
peripheral arterial disease
Classification by specialty
| Cardiology | Vascular surgery | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verify that the event risk of elderly PAD(peripheral arterial disease) patients group administered antiplatelet agent is significantly lower than that of non-administration group
Verify that stains are effective in the treatment for elderly patients with PAD(peripheral arterial disease)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Vascular events
Death(All-cause)
Key secondary outcomes
Major bleeding
Cancer death
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
70 Years of age older
Key exclusion criteria
Patients unable to enforce the ABI test
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeo Nakajima |
Organization
Nakajima Cardiovascular Medicine Mental Clinic
Division name
The director
Zip code
Address
19-13,Omoricho,Hakodate-shi,Hokkaido,040-0034,Japan
TEL
0138-22-4357
shigshig@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuya Yonezawa |
Organization
National Hospital Organaization Hakodate National Hospital
Division name
Department of Cardiology
Zip code
Address
18-16,Kawaharacho,Hakodate-shi,Hokkaido,041-8512,Japan
TEL
0138-51-6281
Homepage URL
kyonezaw@hnh.hosp.go.jp
Sponsor or person
Institute
Hakodate cardiovascular disease round-table conference
Institute
Department
Personal name
Funding Source
Organization
None
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
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
中島内科循環器科メンタルクリニック（北海道）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 02 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 01 | Day |
Other
Other related information
In order to improve the outcome
Management information
Registered date
| 2014 | Year | 04 | Month | 04 | Day |
Last modified on
| 2014 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015909
