Clinical trial NCT01293773: Outcome of Second Generation Drug-eLuting Stents in Patients With Diabetes Mellitus
Official title: Outcome of seCond Generation Drug-ELuting Stents in Patients With Diabetes Mellitus: cOmparison of Three differenT Drug Regimens
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Diabetes Mellitus
Keywords: Randomized controlled trial
Drug-eluting Stent
Multicenter study
Lead sponsor: Policlinico Casilino ASL RMB
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliero-Universitaria di Modena
First posted: 2011-02-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Target lesion failure
timeFrame: 1 year
Secondary outcomes:
measure: Effect of glucose levels on repeat revascularization
timeFrame: 1 year
measure: Target Lesion Revascularization
timeFrame: 1, 2 and 3 year
measure: Effect of dual antiplatelet therapy on outcome
timeFrame: 3 year
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Azienda Policlinico-Universitaria di Modena
city: Rome
country: Italy
facility: Policlinico Casilino
Study officials:
affiliation: Policlinico Casilino
name: Enrico Romagnoli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: