The Beneficial Role of Percutaneous Coronary Intervention Over Optimal Medical Therapy in Elderly Patients With Coronary Artery Disease (BRAVE)
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|