Coronary Artery DiseasePhase 4BRAVENCT01508663
The Beneficial Role of Percutaneous Coronary Intervention Over Optimal Medical Therapy in Elderly Patients With Coronary Artery Disease
A Phase 4 study testing Everolimus Eluting Stent or Zotalolimus Eluting Stent and ARB, CCB, ACE-inhibitor, statin, Nitrate, Antiplate etc. in people with Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 75 to 84 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Everolimus Eluting Stent or Zotalolimus Eluting Stent and ARB, CCB, ACE-inhibitor, statin, Nitrate, Antiplate etc.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2010to Feb 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 to 84 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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%
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- Patients who have received revascularization within the previous 6 months
- Patients with coronary anatomy not suitable for PCI
- Life expectancy ≤ 2 year
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Myeong-Ki, Hong
Seoul
Myeong-Ki Hong, MD.PhD, +82 2 2228 8458, mkhong61@yuhs.ac
About this study
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
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Everolimus Eluting Stent or Zotalolimus Eluting Stent, ARB, CCB, ACE-inhibitor, statin, Nitrate, Antiplate etc.
- Keywords
- Coronary artery disease 75years of age or older
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Everolimus Eluting Stent or Zotalolimus Eluting StentDevice
Everolimus Eluting Stent(Xience V, Xience prime) Zotalolimus Eluting Stent(Endeavor-resolute, Resolute Integrity)
ARB, CCB, ACE-inhibitor, statin, Nitrate, Antiplate etc.Drug
one or two anti-platelet agents, beta-blockers, calcium channel blockers, nitrates, angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs), and statin
| Study group | Role | What they receive |
|---|---|---|
| PCI+OMT group | Experimental | PCI (Everolimus Eluting Stent or Zotalolimus Eluting Stent) added to OMT after randomization and follow up for 12 months Receives: Device: Everolimus Eluting Stent or Zotalolimus Eluting Stent |
| OMT alone group | Active comparator | OMT alone after randomization and follow up for 12 months Receives: Drug: ARB, CCB, ACE-inhibitor, statin, Nitrate, Antiplate etc. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 12month
Secondary outcomes (1)
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
Measured: 12month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startAug 2010
- Primary completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myeong-Ki Hong, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508663
- Sponsor's protocol ID
- 1-2010-0016
- Acronym
- BRAVE
- Status last verified
- Jan 2012
- First submitted
- 3 Jan 2012
- Last updated
- 12 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01508663
- Acronym / sponsor ID
- BRAVE / 1-2010-0016
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease 75years of age or older
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Feb 2014 (estimated)
- First posted
- 12 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCI+OMT group | Experimental | Device: Everolimus Eluting Stent or Zotalolimus Eluting StentPCI (Everolimus Eluting Stent or Zotalolimus Eluting Stent) added to OMT after randomization and follow up for 12 months |
| OMT alone group | Active comparator | Drug: ARB, CCB, ACE-inhibitor, statin, Nitrate, Antiplate etc.OMT alone after randomization and follow up for 12 months |
Who may qualify
- Ages
- 75 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Everolimus Eluting Stent or Zotalolimus Eluting StentEverolimus Eluting Stent(Xience V, Xience prime) Zotalolimus Eluting Stent(Endeavor-resolute, Resolute Integrity) | Device | PCI+OMT group |
| 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 | Drug | OMT alone group |
Primary outcome
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]
1 secondary outcome
cardiac or non-cardiac major adverse event
Time frame: 12month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Everolimus Eluting Stent or Zotalolimus Eluting Stent and ARB, CCB, ACE-inhibitor, statin, Nitrate, Antiplate etc. in people with Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Myeong-Ki Hong, MD.PhD (+82 2 2228 8458, mkhong61@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac Event (time frame: 12month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2012.