Angioplasty, Balloon, CoronaryPhase 3COPERESNCT01752127
COmparison of Xience PrimE Versus REsolute Integrity in Diabetes or Small Vessel Disease
A Phase 3 study testing percutaneous coronary intervention using drug eluting stent in people with Angioplasty, Balloon, Coronary, run by Chonbuk National University Hospital at 1 site in South Korea.
Trial summary
The newer generation ZES (Medtronic, Minneapolis, MN, Resolute Integrity) and EES (Abbott Vascular, Abbott Park, Illinois, Xience Prime) were introduced to South Korea. Although these are thought to be superior in effect and stability compared to ZES and EES of previous generation, there are few clinical data… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Angioplasty, Balloon, Coronary
- What is being tested?
- percutaneous coronary intervention using drug eluting stent
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2011to Jul 2013
- Phase
- Phase 3
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Patients requiring stent procedure (visual diameter stenosis ≥ 50%)
- Stable angina with evidence of myocardial ischemia, acute coronary syndrome(ST segment elevation, non-ST segment elevation acute myocardial infarction, and unstable angina)
- Patients diagnosed of type 2 diabetes or small vessel disease
- Patients willing to participate in the study through written consent
Who cannot join
- Those hypersensitive to or abstaining from heparin, aspirin, clopidogrel, contrast medium, zotarolimus, or everolimus.
- Pregnant women or those having future plans for pregnancy.
- Those having hemorrhagic disease or blood-clotting disorders (including heparin-induced thrombocytopenia), or those rejecting blood transfusion.
- Those having medical history of digestive and urinary system bleeding during the last 3 months, or who have received major surgery within 2 months.
- Those with thrombocytopenia (< 100,000/mm3) or hemoglobin 10.0 g/dL or less.
- Those planning a surgery that requires the discontinuation of antiplatelet drugs within next 12 months (especially, thienopyridines type).
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- When the remaining survival period is expected to be less than 1 year.
- Restenosis lesion
- Left main coronary artery lesion
- Saphenous vein graft stenosis lesion
- Left ventricular ejection fraction < 30%
- Cardiac shock
- Those with liver function failure: When liver enzyme level (ALT) is 3 times the normal upper limit.
- Type I diabetes
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Devision of cardiology, Chonbuk national university hospital
Jeonju, Chon-buk
Lae young Jung, fellow, 82-63-250-2204, young@naver.com
About this study
Official title: Study for Investigate the Effectiveness and Safety of Resolute Integrity or Xience Prime in Diabetes or Small Vessels Lesion Patients
The newer generation ZES (Medtronic, Minneapolis, MN, Resolute Integrity) and EES (Abbott Vascular, Abbott Park, Illinois, Xience Prime) were introduced to South Korea. Although these are thought to be superior in effect and stability compared to ZES and EES of previous generation, there are few clinical data regarding the high risk groups of diabetes patients or small vessels lesion. Moreover, looking at the 8.3% of restenosis in Resolute All Comer study (23% diabetes), the investigators could not know the outcome in high risk patients such as diabetes or small vessels lesion. Therefore, the aim of this study is to investigate the effectiveness and safety of Resolute Integrity or Xience Prime in diabetes or small vessels lesion patients.
- Conditions
- Angioplasty, Balloon, Coronary
- Being tested
- percutaneous coronary intervention using drug eluting stent
- Keywords
- Drug-eluting stent, diabetes, small vessel disease
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous coronary intervention using drug eluting stentProcedure or surgery
Also called using two drug eluting stent(XIENCE PRIME and RESOLUTE INTEGRITY)
- Intracoronary stenting
- The procedure could be conducted via brachial, radial or femoral approaches.
- There are no restrictions regarding lesion's length or diameter. For long lesions, overlapping of several stents would be allowed but only allocated type of stents should be used.
- When several lesions are included in the study of a patient, each lesion may be allocated in different groups. Only if deployment of the allocated stent is not possible, crossing to other stent would be allowed.
- Direct stenting or bifurcation stenting is allowed.
- Predilation before stenting, IVUS examination, and administration of glycoprotein IIb/IIIa inhibitor would be determined by investigator.
| Study group | Role | What they receive |
|---|---|---|
| DM arms | Active comparator | comparison of two different stents(Xience prime and Resolute integrity) Receives: Procedure: percutaneous coronary intervention using drug eluting stent |
| Small vessel arms | Active comparator | comparison of two different stents(Xience prime and Resolute integrity) Receives: Procedure: percutaneous coronary intervention using drug eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
in-segment late lumen loss (mm)at 12month
Measured: 12month
Secondary outcomes (3)
major adverse cardiac events(MACE) at 12month
- Occurrence of major adverse cardiac events (MACE) during 12 months
- Cardiac death
- Target vessel related myocardial infarction
- Ischemia driven Target Vessel Revascularization (TVR)
- Ischemia driven Target Lesion Revascularization (TLR)
- Definite / probable stent thrombosis by ARC definition
Measured: 12month
MACE at 24month
- Occurrence of major adverse cardiac events (MACE) during 24 months
- Cardiac death
- Target vessel related myocardial infarction
- Ischemia driven Target Vessel Revascularization (TVR)
- Ischemia driven Target Lesion Revascularization (TLR)
- Definite / probable stent thrombosis by ARC definition
Measured: 24month
procedure success rate
Procedure success rate proportion of investigational stent deployed successfully without chage to other stent
Measured: 1 day (after procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startJul 2011
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angioplasty, Balloon, CoronaryStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lae Young Jung, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752127
- Sponsor's protocol ID
- The COPERES trial
- Acronym
- COPERES
- Status last verified
- Dec 2012
- First submitted
- 2 Dec 2012
- Last updated
- 19 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for Investigate the Effectiveness and Safety of Resolute Integrity or Xience Prime in Diabetes or Small Vessels Lesion Patients
- ClinicalTrials.gov ID
- NCT01752127
- Acronym / sponsor ID
- COPERES / The COPERES trial
- Conditions
- Angioplasty, Balloon, Coronary
- Keywords
- Drug-eluting stent, diabetes, small vessel disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 19 Dec 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 newer generation ZES (Medtronic, Minneapolis, MN, Resolute Integrity) and EES (Abbott Vascular, Abbott Park, Illinois, Xience Prime) were introduced to South Korea. Although these are thought to be superior in effect and stability compared to ZES and EES of previous generation, there are few clinical data regarding the high risk groups of diabetes patients or small vessels lesion. Moreover, looking at the 8.3% of restenosis in Resolute All Comer study (23% diabetes), the investigators could not know the outcome in high risk patients such as diabetes or small vessels lesion. Therefore, the aim of this study is to investigate the effectiveness and safety of Resolute Integrity or Xience Prime in diabetes or small vessels lesion patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DM arms | Active comparator | Procedure: percutaneous coronary intervention using drug eluting stentcomparison of two different stents(Xience prime and Resolute integrity) |
| Small vessel arms | Active comparator | Procedure: percutaneous coronary intervention using drug eluting stentcomparison of two different stents(Xience prime and Resolute integrity) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years
- Patients requiring stent procedure (visual diameter stenosis ≥ 50%)
- Stable angina with evidence of myocardial ischemia, acute coronary syndrome(ST segment elevation, non-ST segment elevation acute myocardial infarction, and unstable angina)
- Patients diagnosed of type 2 diabetes or small vessel disease
- Patients willing to participate in the study through written consent
Key exclusion criteria (14 listed)
- Those hypersensitive to or abstaining from heparin, aspirin, clopidogrel, contrast medium, zotarolimus, or everolimus.
- Pregnant women or those having future plans for pregnancy.
- Those having hemorrhagic disease or blood-clotting disorders (including heparin-induced thrombocytopenia), or those rejecting blood transfusion.
- Those having medical history of digestive and urinary system bleeding during the last 3 months, or who have received major surgery within 2 months.
- Those with thrombocytopenia (< 100,000/mm3) or hemoglobin 10.0 g/dL or less.
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 |
|---|---|---|
| percutaneous coronary intervention using drug eluting stentAlso: using two drug eluting stent(XIENCE PRIME and RESOLUTE INTEGRITY)1. Intracoronary stenting 1. The procedure could be conducted via brachial, radial or femoral approaches. 2. There are no restrictions regarding lesion's length or diameter. For long lesions, overlapping of several stents would be allowed but only allocated type of stents should be used. 3. When several lesions are included in the study of a patient, each lesion may be allocated in different groups. Only if deployment of the allocated stent is not possible, crossing to other stent would be allowed. 4. Direct stenting or bifurcation stenting is allowed. 5. Predilation before stenting, IVUS examination, and administration of glycoprotein IIb/IIIa inhibitor would be determined by investigator. | Procedure or surgery | DM arms, Small vessel arms |
Primary outcome
in-segment late lumen loss (mm)at 12month
Time frame: 12month
3 secondary outcomes
major adverse cardiac events(MACE) at 12month
Time frame: 12month
MACE at 24month
Time frame: 24month
procedure success rate
Time frame: 1 day (after procedure)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 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 3 study testing percutaneous coronary intervention using drug eluting stent in people with Angioplasty, Balloon, Coronary, run by Chonbuk National University Hospital 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 14 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 19 Dec 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Lae young Jung, fellow (82-63-250-2204, youngjoin@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
in-segment late lumen loss (mm)at 12month (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 19 Dec 2012.