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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01293773

Acronym

OCELOT

Enrollment

Registered

2011-02-11

Start date

2010-10-31

Completion date

2012-12-31

Last updated

2014-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Diabetes Mellitus

Keywords

Randomized controlled trial, Drug-eluting Stent, Multicenter study

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.

Interventions

DEVICETaxus Element stent

paclitaxel-eluting stent

DEVICEIntegrity Resolute stent

ABT 578-eluting stent

DEVICEXience Prime stent

Everolimus-eluting stent

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Target lesion failure	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

Measure	Time frame	Description
Effect of glucose levels on repeat revascularization	1 year	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	1, 2 and 3 year	Target lesion revascularization at 12, 24 and 36 months
Effect of dual antiplatelet therapy on outcome	3 year	Comparison of 12-month versus prolonged (\> 12-month) dual antiplatelet therapy on outcome

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026