COmparison of Xience PrimE Versus REsolute Integrity in Diabetes or Small Vessel Disease (COPERES)

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.

Study Overview

• Status: Unknown
• Conditions: Angioplasty, Balloon, Coronary
• Intervention / Treatment: Procedure: percutaneous coronary intervention using drug eluting stent

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Chon-buk
    • Jeon-Ju, Chon-buk, Korea, Republic of
      • Recruiting
      • Devision of cardiology, Chonbuk national university hospital
      • Contact: Lae young Jung, fellow; Phone Number: 82-63-250-2204; Email: young@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age > 18 years
2. Patients requiring stent procedure (visual diameter stenosis ≥ 50%)
3. Stable angina with evidence of myocardial ischemia, acute coronary syndrome(ST segment elevation, non-ST segment elevation acute myocardial infarction, and unstable angina)
4. Patients diagnosed of type 2 diabetes or small vessel disease
5. Patients willing to participate in the study through written consent

Exclusion Criteria:

1. Those hypersensitive to or abstaining from heparin, aspirin, clopidogrel, contrast medium, zotarolimus, or everolimus.
2. Pregnant women or those having future plans for pregnancy.
3. Those having hemorrhagic disease or blood-clotting disorders (including heparin-induced thrombocytopenia), or those rejecting blood transfusion.
4. Those having medical history of digestive and urinary system bleeding during the last 3 months, or who have received major surgery within 2 months.
5. Those with thrombocytopenia (< 100,000/mm3) or hemoglobin 10.0 g/dL or less.
6. Those planning a surgery that requires the discontinuation of antiplatelet drugs within next 12 months (especially, thienopyridines type).
7. When the remaining survival period is expected to be less than 1 year.
8. Restenosis lesion
9. Left main coronary artery lesion
10. Saphenous vein graft stenosis lesion
11. Left ventricular ejection fraction < 30%
12. Cardiac shock
13. Those with liver function failure: When liver enzyme level (ALT) is 3 times the normal upper limit.
14. Type I diabetes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DM arms; comparison of two different stents(Xience prime and Resolute integrity)	Procedure: percutaneous coronary intervention using drug eluting stent; 1. 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.; Other Names: using two drug eluting stent(XIENCE PRIME and RESOLUTE INTEGRITY)
Active Comparator: Small vessel arms; comparison of two different stents(Xience prime and Resolute integrity)	Procedure: percutaneous coronary intervention using drug eluting stent; 1. 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.; Other Names: using two drug eluting stent(XIENCE PRIME and RESOLUTE INTEGRITY)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
in-segment late lumen loss (mm)at 12month	12month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
major adverse cardiac events(MACE) at 12month	1) 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	12month
MACE at 24month	2) 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	24month
procedure success rate	Procedure success rate proportion of investigational stent deployed successfully without chage to other stent	1 day (after procedure)

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): July 1, 2013
• Study Completion (Anticipated): July 1, 2013

Study Registration Dates

• First Submitted: December 2, 2012
• First Submitted That Met QC Criteria: December 18, 2012
• First Posted (Estimate): December 19, 2012

Study Record Updates

• Last Update Posted (Estimate): December 19, 2012
• Last Update Submitted That Met QC Criteria: December 18, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: diabetes; Drug-eluting stent; small vessel disease
• Other Study ID Numbers: The COPERES trial