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A Randomized Investigation of Short-term Prognosis and Costs and Long-term Prognosis of Medical vs. Coronary Intervention for Low-risk Stable Effort Angina

A Randomized Investigation of Short-term Prognosis and Costs and Long-term Prognosis of Medical vs. Coronary Intervention for Low-risk Stable Effort Angina - Japanese Stable Angina Pectoris Study (JSAP Study)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000000530
Enrollment
400
Registered
2006-11-27
Start date
2002-02-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

low-risk stable effort angina

Interventions

medical therapy as the initial treatment coronary intervention as the initial treatment

Sponsors

The JSAP Study Investigators
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
angina pectoris classification and evaluation of survival

Countries

Japan

Contacts

Public ContactKazuhiko Nishigaki, MD

Gifu University Graduate School of Medicine Second Department of Internal Medicine

nissy@gifu-u.ac.jp058-230-6523

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026