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

Coronary Artery Disease Clinical Trial

— OCELOT  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01293773
• Other study ID #: 007/CE-RMB
• Status: Withdrawn
• Phase: Phase 4
• First received: February 10, 2011
• Last updated: November 6, 2014
• Start date: October 2010
• Est. completion date: December 2012

Study information

• Verified date: August 2011
• Source: Policlinico Casilino ASL RMB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Myocardial Ischemia

Intervention

Device:
• Taxus Element stent
paclitaxel-eluting stent
• Integrity Resolute stent
ABT 578-eluting stent
• Xience Prime stent
Everolimus-eluting stent

Locations

Country	Name	City	State
Italy	Azienda Policlinico-Universitaria di Modena	Modena
Italy	Policlinico Casilino	Rome

Sponsors (2)

Lead Sponsor	Collaborator
Policlinico Casilino ASL RMB	Azienda Ospedaliera - Universitaria di Modena

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Target Lesion Revascularization	Target lesion revascularization at 12, 24 and 36 months	1, 2 and 3 year	No
Secondary	Effect of dual antiplatelet therapy on outcome	Comparison of 12-month versus prolonged (> 12-month) dual antiplatelet therapy on outcome	3 year	No