The Beneficial Role of Percutaneous Coronary Intervention Over Optimal Medical Therapy in Elderly Patients With Coronary Artery Disease

NCT ID: NCT01508663

Last Updated: 2012-01-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 1600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PCI+OMT group

PCI (Everolimus Eluting Stent or Zotalolimus Eluting Stent) added to OMT after randomization and follow up for 12 months

Group Type: EXPERIMENTAL

Everolimus Eluting Stent or Zotalolimus Eluting Stent

Intervention Type: DEVICE

Everolimus Eluting Stent(Xience V, Xience prime) Zotalolimus Eluting Stent(Endeavor-resolute, Resolute Integrity)

OMT alone group

OMT alone after randomization and follow up for 12 months

Group Type: ACTIVE_COMPARATOR

ARB, CCB, ACE-inhibitor, statin, Nitrate, Antiplate etc.

Intervention Type: DRUG

one or two anti-platelet agents, beta-blockers, calcium channel blockers, nitrates, angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs), and statin

Interventions

Everolimus Eluting Stent or Zotalolimus Eluting Stent

Everolimus Eluting Stent(Xience V, Xience prime) Zotalolimus Eluting Stent(Endeavor-resolute, Resolute Integrity)

Intervention Type: DEVICE

ARB, CCB, ACE-inhibitor, statin, Nitrate, Antiplate etc.

one or two anti-platelet agents, beta-blockers, calcium channel blockers, nitrates, angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs), and statin

Intervention Type: DRUG

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

• Minimum Eligible Age: 75 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Myeong-Ki Hong

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Myeong-Ki, Hong

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Myeong-Ki Hong, MD.PhD

Role: CONTACT

mkhong61@yuhs.ac

+82 2 2228 8458

Facility Contacts

Myeong-Ki Hong, MD.PhD

Role: primary

mkhong61@yuhs.ac

+82 2 2228 8458

Other Identifiers

1-2010-0016

Identifier Type: -

Identifier Source: org_study_id