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

This study is currently recruiting participants.
Verified January 2012 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Myeong-Ki Hong, Yonsei University
ClinicalTrials.gov Identifier:
NCT01508663
First received: January 3, 2012
Last updated: January 9, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
 Device: Everolimus Eluting Stent or Zotalolimus Eluting Stent
Drug: ARB, CCB, ACE-inhibitor, statin, Nitrate, Antiplate etc.
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Major Adverse Cardiac Event [ Time Frame: 12month ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12month ] [ Designated as safety issue: No ]
    1. 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.
    2. Major determinant for the occurrence of major events
    3. Sub-study according to the subsets of disease
    4. Association between parameters at index procedure and clinical outcomes


Estimated Enrollment: 1600
Study Start Date: August 2010
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PCI+OMT group
PCI (Everolimus Eluting Stent or Zotalolimus Eluting Stent) added to OMT after randomization and follow up for 12 months
 Device: Everolimus Eluting Stent or Zotalolimus Eluting Stent
Everolimus Eluting Stent(Xience V, Xience prime) Zotalolimus Eluting Stent(Endeavor-resolute, Resolute Integrity)
Active Comparator: OMT alone group
OMT alone after randomization and follow up for 12 months
 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

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

Ages Eligible for Study:   75 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508663

Contacts
Contact: Myeong-Ki Hong, MD.PhD +82 2 2228 8458 mkhong61@yuhs.ac

Locations
Korea, Republic of
Myeong-Ki, Hong Recruiting
Seoul, Korea, Republic of
Contact: Myeong-Ki Hong, MD.PhD     +82 2 2228 8458     mkhong61@yuhs.ac    
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Myeong-Ki Hong, Professor, Yonsei University
ClinicalTrials.gov Identifier: NCT01508663     History of Changes
Other Study ID Numbers: 1-2010-0016
Study First Received: January 3, 2012
Last Updated: January 9, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Yonsei University:
Coronary artery disease 75years of age or older

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Everolimus
Sirolimus
Protease Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 19, 2013