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

Outcome of seCond Generation Drug-ELuting Stents in Patients With Diabetes Mellitus: cOmparison of Three differenT Drug Regimens

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

Study Overview

• Status: Withdrawn
• Conditions: Coronary Artery Disease; Diabetes Mellitus
• Intervention / Treatment: Device: Taxus Element stent; Device: Xience Prime stent; Device: Integrity Resolute stent

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.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Modena, Italy, 41100
    • Azienda Policlinico-Universitaria di Modena
  • Rome, Italy, 00100
    • Policlinico Casilino

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Taxus Element; Patients treated with paclitaxel-eluting stent (Taxus Element, Boston Scientific, MN)	Device: Taxus Element stent; paclitaxel-eluting stent; Other Names: Taxus
Active Comparator: Xience Prime; Patients treated with Everolimus-eluting stent (Xience Prime, Abbott, IL)	Device: Xience Prime stent; Everolimus-eluting stent; Other Names: Xience Prime
Active Comparator: Integrity Resolute; Patients treated with ABT 578-eluting stent (Integrity Resolute, Medtronic, MA)	Device: Integrity Resolute stent; ABT 578-eluting stent; Other Names: Resolute Integrity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year
Target Lesion Revascularization	Target lesion revascularization at 12, 24 and 36 months	1, 2 and 3 year
Effect of dual antiplatelet therapy on outcome	Comparison of 12-month versus prolonged (> 12-month) dual antiplatelet therapy on outcome	3 year

Collaborators and Investigators

• Sponsor: Policlinico Casilino ASL RMB
• Collaborators: Azienda Ospedaliero-Universitaria di Modena
• Investigators: Principal Investigator: Enrico Romagnoli, MD, PhD, Policlinico Casilino

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: February 10, 2011
• First Submitted That Met QC Criteria: February 10, 2011
• First Posted (Estimate): February 11, 2011

Study Record Updates

• Last Update Posted (Estimate): November 7, 2014
• Last Update Submitted That Met QC Criteria: November 6, 2014
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Drug-eluting Stent; Multicenter study
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Endocrine System Diseases; Coronary Disease; Coronary Artery Disease; Diabetes Mellitus
• Other Study ID Numbers: 007/CE-RMB