The Beneficial Role of Percutaneous Coronary Intervention Over Optimal Medical Therapy in Elderly Patients With Coronary Artery Disease (BRAVE)
|ClinicalTrials.gov Identifier: NCT01508663|
Recruitment Status : Unknown
Verified January 2012 by Myeong-Ki Hong, Yonsei University.
Recruitment status was: Recruiting
First Posted : January 12, 2012
Last Update Posted : January 12, 2012
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Device: Everolimus Eluting Stent or Zotalolimus Eluting Stent Drug: ARB, CCB, ACE-inhibitor, statin, Nitrate, Antiplate etc.||Phase 4|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||August 2010|
|Estimated Primary Completion Date :||February 2014|
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
- Major Adverse Cardiac Event [ Time Frame: 12month ]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]
- cardiac or non-cardiac major adverse event [ Time Frame: 12month ]
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01508663
|Contact: Myeong-Ki Hong, MD.PhD||+82 2 2228 firstname.lastname@example.org|
|Korea, Republic of|
|Seoul, Korea, Republic of|
|Contact: Myeong-Ki Hong, MD.PhD +82 2 2228 8458 email@example.com|