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Outcome of Second Generation Drug-eLuting Stents in Patients With Diabetes Mellitus (OCELOT)

Primary Purpose

Coronary Artery Disease, Diabetes Mellitus

Status
Withdrawn
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Taxus Element stent
Integrity Resolute stent
Xience Prime stent
Sponsored by
Policlinico Casilino ASL RMB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Randomized controlled trial, Drug-eluting Stent, Multicenter study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject is > 18 years old
  2. Presence of one or more de novo stenosis equal or greater than 70% in a native coronary artery, treated with a second generation drug-eluting stent
  3. Subject and the treating physician agree that the subject will comply with all follow-up evaluations
  4. Subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site

Exclusion Criteria:

  1. Subject's age is < 18 years and with acute myocardial infarction in the 48 prior to the procedure
  2. The patient is pregnant or breastfeeding
  3. Known allergies to: aspirin, clopidogrel (Plavix) and ticlopidine (tiklid), heparin, Paclitaxel, Everolimus, ABT 578, stainless steel, or contrast agent (which cannot be adequately pre-medicated)
  4. A platelet count < 75,000 cells/mm3 or > 700,000 cells/mm3 or a WBC < 3,000 cells/mm3
  5. Subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
  6. Prior participation in this study
  7. Active peptic ulcer or upper GI bleeding within the prior 3 months
  8. Subject has active sepsis
  9. Any lesion that is located in a saphenous vein graft
  10. In the investigator's opinion, subject has a co-morbid condition(s) that could limit the life expectancy to less than one year, or limit the subject's ability to participate in the study or comply with follow-up requirements or impact the scientific integrity of the study

Sites / Locations

  • Azienda Policlinico-Universitaria di Modena
  • Policlinico Casilino

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Taxus Element

Xience Prime

Integrity Resolute

Arm Description

Patients treated with paclitaxel-eluting stent (Taxus Element, Boston Scientific, MN)

Patients treated with Everolimus-eluting stent (Xience Prime, Abbott, IL)

Patients treated with ABT 578-eluting stent (Integrity Resolute, Medtronic, MA)

Outcomes

Primary Outcome Measures

Target lesion failure
Target lesion failure (TLF) defined as the occurrence of cardiac death, target vessel-related myocardial infarction and repeated revascularization of the target lesion

Secondary Outcome Measures

Effect of glucose levels on repeat revascularization
Impact of glucose level during the three months following the procedure (assessed by hemoglobin A1C ) on clinically-driven target lesion revascularization rate
Target Lesion Revascularization
Target lesion revascularization at 12, 24 and 36 months
Effect of dual antiplatelet therapy on outcome
Comparison of 12-month versus prolonged (> 12-month) dual antiplatelet therapy on outcome

Full Information

First Posted
February 10, 2011
Last Updated
November 6, 2014
Sponsor
Policlinico Casilino ASL RMB
Collaborators
Azienda Ospedaliero-Universitaria di Modena
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1. Study Identification

Unique Protocol Identification Number
NCT01293773
Brief Title
Outcome of Second Generation Drug-eLuting Stents in Patients With Diabetes Mellitus
Acronym
OCELOT
Official Title
Outcome of seCond Generation Drug-ELuting Stents in Patients With Diabetes Mellitus: cOmparison of Three differenT Drug Regimens
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Withdrawn
Study Start Date
October 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Policlinico Casilino ASL RMB
Collaborators
Azienda Ospedaliero-Universitaria di Modena

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Design: prospective, randomized, multi-center trial comparing the safety and efficacy in the prevention of target lesion failure (TLF) of second generation paclitaxel- versus ABT578- versus Everolimus- eluting stents Study Population: all consecutive diabetic patients with de novo coronary artery lesions undergoing drug-eluting stent implantation in 2010-12. Time Course: initial Enrollment: October 2010; end of the Enrollment: December 2012 Primary End-Point: target lesion revascularization (TLF) defined as the occurrence of cardiac death, myocardial infarction and repeated lesion revascularization within 12 months. Secondary End-Points: 1) impact of glucose level during the first three months following the procedure (assessed by hemoglobin A1C ) on clinically-driven target lesion revascularization; 2)TLF and TLR within 12, 24 and 36 months; 3) comparison 12 months versus prolonged (> 12 months) of dual antiplatelet therapy
Detailed Description
Prospective, randomized, triple arm study. The study population will include all consecutive diabetic patients within 24 months undergoing elective second generation DES implantation for de novo coronary artery disease. In the randomization process all participating centers will be equally stratified to avoid statistical unbalance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Diabetes Mellitus
Keywords
Randomized controlled trial, Drug-eluting Stent, Multicenter study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Taxus Element
Arm Type
Active Comparator
Arm Description
Patients treated with paclitaxel-eluting stent (Taxus Element, Boston Scientific, MN)
Arm Title
Xience Prime
Arm Type
Active Comparator
Arm Description
Patients treated with Everolimus-eluting stent (Xience Prime, Abbott, IL)
Arm Title
Integrity Resolute
Arm Type
Active Comparator
Arm Description
Patients treated with ABT 578-eluting stent (Integrity Resolute, Medtronic, MA)
Intervention Type
Device
Intervention Name(s)
Taxus Element stent
Other Intervention Name(s)
Taxus
Intervention Description
paclitaxel-eluting stent
Intervention Type
Device
Intervention Name(s)
Integrity Resolute stent
Other Intervention Name(s)
Resolute Integrity
Intervention Description
ABT 578-eluting stent
Intervention Type
Device
Intervention Name(s)
Xience Prime stent
Other Intervention Name(s)
Xience Prime
Intervention Description
Everolimus-eluting stent
Primary Outcome Measure Information:
Title
Target lesion failure
Description
Target lesion failure (TLF) defined as the occurrence of cardiac death, target vessel-related myocardial infarction and repeated revascularization of the target lesion
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Effect of glucose levels on repeat revascularization
Description
Impact of glucose level during the three months following the procedure (assessed by hemoglobin A1C ) on clinically-driven target lesion revascularization rate
Time Frame
1 year
Title
Target Lesion Revascularization
Description
Target lesion revascularization at 12, 24 and 36 months
Time Frame
1, 2 and 3 year
Title
Effect of dual antiplatelet therapy on outcome
Description
Comparison of 12-month versus prolonged (> 12-month) dual antiplatelet therapy on outcome
Time Frame
3 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is > 18 years old Presence of one or more de novo stenosis equal or greater than 70% in a native coronary artery, treated with a second generation drug-eluting stent Subject and the treating physician agree that the subject will comply with all follow-up evaluations Subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site Exclusion Criteria: Subject's age is < 18 years and with acute myocardial infarction in the 48 prior to the procedure The patient is pregnant or breastfeeding Known allergies to: aspirin, clopidogrel (Plavix) and ticlopidine (tiklid), heparin, Paclitaxel, Everolimus, ABT 578, stainless steel, or contrast agent (which cannot be adequately pre-medicated) A platelet count < 75,000 cells/mm3 or > 700,000 cells/mm3 or a WBC < 3,000 cells/mm3 Subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints Prior participation in this study Active peptic ulcer or upper GI bleeding within the prior 3 months Subject has active sepsis Any lesion that is located in a saphenous vein graft In the investigator's opinion, subject has a co-morbid condition(s) that could limit the life expectancy to less than one year, or limit the subject's ability to participate in the study or comply with follow-up requirements or impact the scientific integrity of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrico Romagnoli, MD, PhD
Organizational Affiliation
Policlinico Casilino
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Policlinico-Universitaria di Modena
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Policlinico Casilino
City
Rome
ZIP/Postal Code
00100
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Outcome of Second Generation Drug-eLuting Stents in Patients With Diabetes Mellitus

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