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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000530
Receipt No. 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

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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
Email

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/
Email nissy@gifu-u.ac.jp

Sponsor
Institute The JSAP Study Investigators
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000641

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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