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

This study has been withdrawn prior to enrollment.
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: November 6, 2014
Last verified: August 2011

February 10, 2011
November 6, 2014
October 2010
October 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01293773 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Outcome of Second Generation Drug-eLuting Stents in Patients With Diabetes Mellitus
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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Coronary Artery Disease
  • Diabetes Mellitus
  • Device: Taxus Element stent
    paclitaxel-eluting stent
    Other Name: Taxus
  • Device: Integrity Resolute stent
    ABT 578-eluting stent
    Other Name: Resolute Integrity
  • Device: Xience Prime stent
    Everolimus-eluting stent
    Other Name: Xience Prime
  • Active Comparator: Taxus Element
    Patients treated with paclitaxel-eluting stent (Taxus Element, Boston Scientific, MN)
    Intervention: Device: Taxus Element stent
  • Active Comparator: Xience Prime
    Patients treated with Everolimus-eluting stent (Xience Prime, Abbott, IL)
    Intervention: Device: Xience Prime stent
  • Active Comparator: Integrity Resolute
    Patients treated with ABT 578-eluting stent (Integrity Resolute, Medtronic, MA)
    Intervention: Device: Integrity Resolute stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01293773
007/CE-RMB
Yes
Enrico Romagnoli, Policlinico Casilino
Policlinico Casilino ASL RMB
Azienda Ospedaliera - Universitaria di Modena
Principal Investigator: Enrico Romagnoli, MD, PhD Policlinico Casilino
Policlinico Casilino ASL RMB
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP