Status:
UNKNOWN
The Beneficial Role of Percutaneous Coronary Intervention Over Optimal Medical Therapy in Elderly Patients With Coronary Artery Disease
Lead Sponsor:
Yonsei University
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
75-84 years
Phase:
PHASE4
Brief Summary
The primary purpose of this study is to determine whether PCI added to OMT could be superior over OMT alone in the prevention of late adverse cardiac and cerebro-vascular events in elderly patients wi...
Detailed Description
Study Design * Prospective, randomized, multi-center study of each 1600 subjects enrolled. * Eligible subjects will be randomized 1:1 to a) PCI added to OMT (n=800) vs. b) OMT alone(n=800). Subseque...
Eligibility Criteria
Inclusion
- Patients with CAD and those in whom initial CCS class I to III angina or Braunwald classification less than IIB
- Patients with age 75 years or older
- Patients receiving OMT (one or two anti-platelet agents, beta-blockers, calcium channel blockers, nitrates, angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs), and statin)
- Patients with stenosis of at least 70% in at least one proximal epicardial coronary artery or objective evidence of myocardial ischemia (substantial changes in ST-segment depression or T-wave inversion on the resting electrocardiogram or inducible ischemia with either exercise or pharmacologic vasodilator stress)
- Patients with signed informed consent
Exclusion
- Patients with persistence of CCS IV angina
- Resting chest pain (≥ Braunwald classification IIB)
- Patients who experienced a markedly positive stress test (substantial ST- segment depression or hypotensive response during stage 1 of the Bruce protocol)
- Patients with age 85 years or older
- Patients with refractory CHF or cardiogenic shock
- Patients with an EF of less than 30%
- Patients who have received revascularization within the previous 6 months
- Patients with coronary anatomy not suitable for PCI
- Life expectancy ≤ 2 year
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
1600 Patients enrolled
Trial Details
Trial ID
NCT01508663
Start Date
August 1 2010
Last Update
January 12 2012
Active Locations (1)
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1
Myeong-Ki, Hong
Seoul, South Korea