Clinical trial NCT01508663: The Beneficial Role of Percutaneous Coronary Intervention Over Optimal Medical Therapy in Elderly Patients With Coronary Artery Disease
Official title: The Beneficial Role of Percutaneous Coronary Intervention Over Optimal Medical Therapy in Elderly Patients (Age > 75 Years Old) With Coronary Artery Disease: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease 75years of age or older
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-01-12
Enrollment: 1600
Sex: ALL
Minimum age (years): 75
Maximum age (years): 84
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 with coronary artery disease (CAD) during the additional 12 months.

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).

Subsequently, subjects in PCI added to OMT group will be randomly assigned to everolimus eluting stent(n=400) vs. zotarolimus eluting sten(n=400). All subjects will be followed for 1 year after randomization. Additional long-term follow-up (2- or 3-year) will be preceded in the next plan after 1-year study period.

* Subjects with CAD who meet all inclusion and exclusion criteria will be included
* Clinical and laboratory follow-up should be performed.

Eligibility criteria: Inclusion Criteria:

1. Patients with CAD and those in whom initial CCS class I to III angina or Braunwald classification less than IIB
2. Patients with age 75 years or older
3. 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)
4. 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)
5. Patients with signed informed consent

Exclusion Criteria:

1. Patients with persistence of CCS IV angina
2. Resting chest pain (≥ Braunwald classification IIB)
3. Patients who experienced a markedly positive stress test (substantial ST- segment depression or hypotensive response during stage 1 of the Bruce protocol)
4. Patients with age 85 years or older
5. Patients with refractory CHF or cardiogenic shock
6. Patients with an EF of less than 30%
7. Patients who have received revascularization within the previous 6 months
8. Patients with coronary anatomy not suitable for PCI
9. Life expectancy ≤ 2 year

Primary outcomes:
measure: Major Adverse Cardiac Event
timeFrame: 12month
Secondary outcomes:
measure: cardiac or non-cardiac major adverse event
timeFrame: 12month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Myeong-Ki, Hong
Study officials:
References: