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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01293773
Recruitment Status : Withdrawn
First Posted : February 11, 2011
Last Update Posted : November 7, 2014
Azienda Ospedaliero-Universitaria di Modena
Information provided by:
Policlinico Casilino ASL RMB

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

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Diabetes Mellitus Device: Taxus Element stent Device: Integrity Resolute stent Device: Xience Prime stent Phase 4

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  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outcome of seCond Generation Drug-ELuting Stents in Patients With Diabetes Mellitus: cOmparison of Three differenT Drug Regimens
Study Start Date : October 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : December 2012

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 Name: Taxus
Active Comparator: Xience Prime
Patients treated with Everolimus-eluting stent (Xience Prime, Abbott, IL)
Device: Xience Prime stent
Everolimus-eluting stent
Other Name: 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 Name: Resolute Integrity

Primary Outcome Measures :
  1. Target lesion failure [ Time Frame: 1 year ]
    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 :
  1. Effect of glucose levels on repeat revascularization [ Time Frame: 1 year ]
    Impact of glucose level during the three months following the procedure (assessed by hemoglobin A1C ) on clinically-driven target lesion revascularization rate

  2. Target Lesion Revascularization [ Time Frame: 1, 2 and 3 year ]
    Target lesion revascularization at 12, 24 and 36 months

  3. Effect of dual antiplatelet therapy on outcome [ Time Frame: 3 year ]
    Comparison of 12-month versus prolonged (> 12-month) dual antiplatelet therapy on outcome

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01293773

Azienda Policlinico-Universitaria di Modena
Modena, Italy, 41100
Policlinico Casilino
Rome, Italy, 00100
Sponsors and Collaborators
Policlinico Casilino ASL RMB
Azienda Ospedaliero-Universitaria di Modena
Principal Investigator: Enrico Romagnoli, MD, PhD Policlinico Casilino

Responsible Party: Enrico Romagnoli, Policlinico Casilino Identifier: NCT01293773     History of Changes
Other Study ID Numbers: 007/CE-RMB
First Posted: February 11, 2011    Key Record Dates
Last Update Posted: November 7, 2014
Last Verified: August 2011

Keywords provided by Policlinico Casilino ASL RMB:
Randomized controlled trial
Drug-eluting Stent
Multicenter study

Additional relevant MeSH terms:
Diabetes Mellitus
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases