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

UMIN ID: UMIN000000530

Registered date:27/11/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: low-risk stable effort angina
• Date of first enrollment: 2002/02/01
• Target sample size: 400
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: 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 Outcome: angina pectoris classification and evaluation of survival

Key inclusion & exclusion criteria

• Age minimum: 30years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: The JSAP Study Investigators
• Source(s) of Monetary Support: Health and Labour Sciences Research Grant (Clinical Research for Evidence Based Medicine) from the Japanese Ministry of Health, Labour and Welfare Japan Heart Foundation