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

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Everolimus Eluting Stent or Zotalolimus Eluting Stent
ARB, CCB, ACE-inhibitor, statin, Nitrate, Antiplate etc.
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary artery disease 75years of age or older

Eligibility Criteria

75 Years - 84 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Myeong-Ki, HongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PCI+OMT group

OMT alone group

Arm Description

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

OMT alone after randomization and follow up for 12 months

Outcomes

Primary Outcome Measures

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]

Secondary Outcome Measures

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

Full Information

First Posted
January 3, 2012
Last Updated
January 9, 2012
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01508663
Brief Title
The Beneficial Role of Percutaneous Coronary Intervention Over Optimal Medical Therapy in Elderly Patients With Coronary Artery Disease
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery disease 75years of age or older

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PCI+OMT group
Arm Type
Experimental
Arm Description
PCI (Everolimus Eluting Stent or Zotalolimus Eluting Stent) added to OMT after randomization and follow up for 12 months
Arm Title
OMT alone group
Arm Type
Active Comparator
Arm Description
OMT alone after randomization and follow up for 12 months
Intervention Type
Device
Intervention Name(s)
Everolimus Eluting Stent or Zotalolimus Eluting Stent
Intervention Description
Everolimus Eluting Stent(Xience V, Xience prime) Zotalolimus Eluting Stent(Endeavor-resolute, Resolute Integrity)
Intervention Type
Drug
Intervention Name(s)
ARB, CCB, ACE-inhibitor, statin, Nitrate, Antiplate etc.
Intervention Description
one or two anti-platelet agents, beta-blockers, calcium channel blockers, nitrates, angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs), and statin
Primary Outcome Measure Information:
Title
Major Adverse Cardiac Event
Description
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]
Time Frame
12month
Secondary Outcome Measure Information:
Title
cardiac or non-cardiac major adverse event
Description
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
Time Frame
12month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Myeong-Ki Hong, MD.PhD
Phone
+82 2 2228 8458
Email
mkhong61@yuhs.ac
Facility Information:
Facility Name
Myeong-Ki, Hong
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myeong-Ki Hong, MD.PhD
Phone
+82 2 2228 8458
Email
mkhong61@yuhs.ac

12. IPD Sharing Statement

Learn more about this trial

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

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