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

NCT01293773 | Withdrawn Phase 4 DMC

• 1 other identifier: 007/CE-RMB
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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

Conditions

Coronary Artery Disease; Diabetes Mellitus

Keywords

Randomized controlled trial; Drug-eluting Stent; Multicenter study

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Effect of glucose levels on repeat revascularization

  1 year

• Target Lesion Revascularization

  1, 2 and 3 year

• Effect of dual antiplatelet therapy on outcome

  3 year

Study Arms (3)

Taxus Element

ACTIVE COMPARATOR

Patients treated with paclitaxel-eluting stent (Taxus Element, Boston Scientific, MN)

Device: Taxus Element stent

Xience Prime

ACTIVE COMPARATOR

Patients treated with Everolimus-eluting stent (Xience Prime, Abbott, IL)

Device: Xience Prime stent

Integrity Resolute

ACTIVE COMPARATOR

Patients treated with ABT 578-eluting stent (Integrity Resolute, Medtronic, MA)

Device: Integrity Resolute stent

Interventions

Taxus Element stent DEVICE

paclitaxel-eluting stent

Also known as: Taxus

Taxus Element

Integrity Resolute stent DEVICE

ABT 578-eluting stent

Also known as: Resolute Integrity

Integrity Resolute

Xience Prime stent DEVICE

Everolimus-eluting stent

Also known as: Xience Prime

Xience Prime

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is \> 18 years old
• 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
• Subject and the treating physician agree that the subject will comply with all follow-up evaluations
• 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

You may not qualify if:

• Subject's age is \< 18 years and with acute myocardial infarction in the 48 prior to the procedure
• The patient is pregnant or breastfeeding
• 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)
• A platelet count \< 75,000 cells/mm3 or \> 700,000 cells/mm3 or a WBC \< 3,000 cells/mm3
• 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
• Prior participation in this study
• Active peptic ulcer or upper GI bleeding within the prior 3 months
• Subject has active sepsis
• Any lesion that is located in a saphenous vein graft
• 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

Sponsors & Collaborators

• Policlinico Casilino ASL RMB: lead
• Azienda Ospedaliero-Universitaria di Modena: collaborator

Study Sites (2)

Azienda Policlinico-Universitaria di Modena

Modena, Modena, 41100, Italy

Location

Policlinico Casilino

Rome, Rome, 00100, Italy

Location

MeSH Terms

Conditions

Coronary Artery Disease; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Enrico Romagnoli, MD, PhD

  Policlinico Casilino

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 10, 2011
• First Posted: February 11, 2011
• Study Start: October 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 7, 2014

Record last verified: 2011-08

Locations

IT (2)