UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000530 |
|---|---|
| Receipt number | R000000641 |
| Scientific Title | A Randomized Investigation of Short-term Prognosis and Costs and Long-term Prognosis of Medical vs. Coronary Intervention for Low-risk Stable Effort Angina |
| Date of disclosure of the study information | 2006/11/27 |
| Last modified on | 2006/11/27 21:18:39 |
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Basic information
Public title
A Randomized Investigation of Short-term Prognosis and Costs and Long-term Prognosis of Medical vs. Coronary Intervention for Low-risk Stable Effort Angina
Acronym
Japanese Stable Angina Pectoris Study (JSAP Study)
Scientific Title
A Randomized Investigation of Short-term Prognosis and Costs and Long-term Prognosis of Medical vs. Coronary Intervention for Low-risk Stable Effort Angina
Scientific Title:Acronym
Japanese Stable Angina Pectoris Study (JSAP Study)
Region
| Japan |
Condition
Condition
low-risk stable effort angina
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine which of medical therapy and coronary intervention as the initial treatment is better for patients with low-risk stable effort angina indicated for intervention at the viewpoint of the short-term and long-term prognoses of intervention and its costs during the initial 1 year.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
death (total death, cardiac death, sudden death), acute coronary syndrome (Q-wave infarction, non-Q wave infarction, unstable angina pectoris), and cerebrovascular diseases such as cerebral infarction and cerebral hemorrhage
Key secondary outcomes
angina pectoris classification and evaluation of survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
medical therapy as the initial treatment
Interventions/Control_2
coronary intervention as the initial treatment
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
| 30 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
low-risk stable effort angina indicating 1-vessel or 2-vessel disease without stenotic lesions in LMT or the ostial leasion in LAD (within 5 mm from the bifurcation) in whom CAG shows significant stenosis in the culprit lesion, and PCI/CABG is indicated
Key exclusion criteria
1) Lesions in LMT or at the ostial site of LAD (within 5 mm from bifurcation)
2) 3-vessel disease
3) 2-vessel chronic total obstruction
4) 1-vessel chronic complete obstruction for which the possibility of PCI success is low (long-term chronic complete obstruction, long complete obstruction lesions)
5) Acute myocardial infarction
6) Ejection fraction of left ventricle less than 50%
7) Lesions not indicated for PCI/CABG (thin lateral branches, peripheral branches)
8) Complications such as bleeding tendency, DIC, and severe pneumonia
9) Impaired renal function (Cr > 1.5 mg/dl)
10) Patients with severe ASO and aneurysms not indicated for PCI/CABG
11) Patients with asymptomatic myocardial ischemia not complicated by effort angina pectoris
12) Patients with unstable angina pectoris who newly developed symptoms or showed aggravation within 6 weeks
13) CABG patients with graft stenosis as a responsible lesion
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisayoshi Fujiwara, MD |
Organization
Gifu University Graduate School of Medicine
Division name
Second Department of Internal Medicine
Zip code
Address
Yanagido 1-1, Gifu City, Gifu, JAPAN
TEL
058-230-6523
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Nishigaki, MD |
Organization
Gifu University Graduate School of Medicine
Division name
Second Department of Internal Medicine
Zip code
Address
Yanagido 1-1, Gifu City, Gifu, JAPAN
TEL
058-230-6523
Homepage URL
http://poppy.ac/jsap/
nissy@gifu-u.ac.jp
Sponsor or person
Institute
The JSAP Study Investigators
Institute
Department
Personal name
Funding Source
Organization
Health and Labour Sciences Research Grant (Clinical Research for Evidence Based Medicine) from the Japanese Ministry of Health, Labour and Welfare
Japan Heart Foundation
Organization
Division
Category of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2006 | Year | 11 | Month | 27 | 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
Completed
Date of protocol fixation
| 2002 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2002 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 11 | Month | 27 | Day |
Last modified on
| 2006 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000641
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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