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

Coronary Artery Disease Clinical Trial

— BRAVE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01508663
• Other study ID #: 1-2010-0016
• Status: Recruiting
• Phase: Phase 4
• First received: January 3, 2012
• Last updated: January 9, 2012
• Start date: August 2010

Study information

• Verified date: January 2012
• Source: Yonsei University
• Contact: Myeong-Ki Hong, MD.PhD
• Phone: +82 2 2228 8458
• Email: mkhong61[@]yuhs.ac
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 75 Years to 84 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Everolimus Eluting Stent or Zotalolimus Eluting Stent
Everolimus Eluting Stent(Xience V, Xience prime) Zotalolimus Eluting Stent(Endeavor-resolute, Resolute Integrity)

Drug:
• 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

Locations

Country	Name	City	State
Korea, Republic of	Myeong-Ki, Hong	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiac Event	The primary end-point is the occurrence of major adverse cardiac event [cardiovascular death, non-fatal MI (excluding periprocedural MI), stroke or any revascularization (PCI or coronary bypass surgery [CABG]) for 12 months following the randomization to the assigned management]	12month	No
Secondary	cardiac or non-cardiac major adverse event	The composite of cardiac or non-cardiac death, non-fatal MI, stent thrombosis (ST), target vessel revascularization (TVR) (either by PCI or CABG), non-TVR, hospitalization for unstable angina pectoris (UAP) or congestive heart failure (CHF), and cerebrovascular accident (CVA) for 12 months.; Major determinant for the occurrence of major events; Sub-study according to the subsets of disease; Association between parameters at index procedure and clinical outcomes	12month	No