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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Policlinico Casilino ASL RMB.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Azienda Ospedaliera - Universitaria di Modena
Information provided by:
Policlinico Casilino ASL RMB
ClinicalTrials.gov Identifier:
NCT01293773
First received: February 10, 2011
Last updated: August 16, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Coronary Artery Disease
Diabetes Mellitus
Device: Taxus Element stent
Device: Integrity Resolute stent
Device: Xience Prime stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Policlinico Casilino ASL RMB:

Primary Outcome Measures:
  • Target lesion failure [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1, 2 and 3 year ] [ Designated as safety issue: No ]
    Target lesion revascularization at 12, 24 and 36 months

  • Effect of dual antiplatelet therapy on outcome [ Time Frame: 3 year ] [ Designated as safety issue: No ]
    Comparison of 12-month versus prolonged (> 12-month) dual antiplatelet therapy on outcome


Estimated Enrollment: 750
Study Start Date: October 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01293773

Locations
Italy
Azienda Policlinico-Universitaria di Modena Recruiting
Modena, Italy, 41100
Contact: Giuseppe M Sangiorgi, MD, PhD       gsangiorgi@gmail.com   
Principal Investigator: Giuseppe M Sangiorgi, MD, PhD         
Policlinico Casilino Recruiting
Rome, Italy, 00100
Contact: Enrico Romagnoli, MD, PhD    +390623188471    enromagnoli@gmail.com   
Principal Investigator: Enrico Romagnoli, MD, PhD         
Sub-Investigator: Alessandro Sciahbasi, MD         
Sponsors and Collaborators
Policlinico Casilino ASL RMB
Azienda Ospedaliera - Universitaria di Modena
Investigators
Principal Investigator: Enrico Romagnoli, MD, PhD Policlinico Casilino
  More Information

No publications provided

Responsible Party: Enrico Romagnoli, Policlinico Casilino
ClinicalTrials.gov Identifier: NCT01293773     History of Changes
Other Study ID Numbers: 007/CE-RMB
Study First Received: February 10, 2011
Last Updated: August 16, 2011
Health Authority: Italy: National Institute of Health

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

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

ClinicalTrials.gov processed this record on August 01, 2014