Outcome of Second Generation Drug-eLuting Stents in Patients With Diabetes Mellitus (OCELOT)
This study is currently recruiting participants.
Verified August 2011 by Policlinico Casilino ASL RMB
Sponsor:
Policlinico Casilino ASL RMB
Collaborator:
Azienda Ospedaliera - Universitaria di Modena
Information provided by:
Policlinico Casilino ASL RMB
ClinicalTrials.gov Identifier:
NCT01293773
First received: February 10, 2011
Last updated: August 16, 2011
Last verified: August 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease Diabetes Mellitus |
Device: Taxus Element stent Device: Integrity Resolute stent Device: Xience Prime stent |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Outcome of seCond Generation Drug-ELuting Stents in Patients With Diabetes Mellitus: cOmparison of Three differenT Drug Regimens |
Resource links provided by NLM:
Further study details as provided by Policlinico Casilino ASL RMB:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 750 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Taxus Element
Patients treated with paclitaxel-eluting stent (Taxus Element, Boston Scientific, MN)
|
Device: Taxus Element stent
paclitaxel-eluting stent
Other Name: Taxus
|
|
Active Comparator: Xience Prime
Patients treated with Everolimus-eluting stent (Xience Prime, Abbott, IL)
|
Device: Xience Prime stent
Everolimus-eluting stent
Other Name: Xience Prime
|
|
Active Comparator: Integrity Resolute
Patients treated with ABT 578-eluting stent (Integrity Resolute, Medtronic, MA)
|
Device: Integrity Resolute stent
ABT 578-eluting stent
Other Name: Resolute Integrity
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01293773
Locations
| Italy | |
| Azienda Policlinico-Universitaria di Modena | Recruiting |
| Modena, Italy, 41100 | |
| Contact: Giuseppe M Sangiorgi, MD, PhD gsangiorgi@gmail.com | |
| Principal Investigator: Giuseppe M Sangiorgi, MD, PhD | |
| Policlinico Casilino | Recruiting |
| Rome, Italy, 00100 | |
| Contact: Enrico Romagnoli, MD, PhD +390623188471 enromagnoli@gmail.com | |
| Principal Investigator: Enrico Romagnoli, MD, PhD | |
| Sub-Investigator: Alessandro Sciahbasi, MD | |
Sponsors and Collaborators
Policlinico Casilino ASL RMB
Azienda Ospedaliera - Universitaria di Modena
Investigators
| Principal Investigator: | Enrico Romagnoli, MD, PhD | Policlinico Casilino |
More Information
No publications provided
| Responsible Party: | Enrico Romagnoli, Policlinico Casilino |
| ClinicalTrials.gov Identifier: | NCT01293773 History of Changes |
| Other Study ID Numbers: | 007/CE-RMB |
| Study First Received: | February 10, 2011 |
| Last Updated: | August 16, 2011 |
| Health Authority: | Italy: National Institute of Health |
Keywords provided by Policlinico Casilino ASL RMB:
|
Randomized controlled trial Drug-eluting Stent Multicenter study |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Diabetes Mellitus Heart Diseases Cardiovascular Diseases |
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013