Coronary Artery DiseasePhase 4OCELOTNCT01293773
Outcome of Second Generation Drug-eLuting Stents in Patients With Diabetes Mellitus
A Phase 4 study testing Taxus Element stent, Integrity Resolute stent and Xience Prime stent in people with Coronary Artery Disease and Diabetes Mellitus, run by Policlinico Casilino ASL RMB at 2 sites in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Diabetes Mellitus
- What is being tested?
- Taxus Element stent, Integrity Resolute stent and Xience Prime stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesItaly
- Study dates
- Oct 2010to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Azienda Policlinico-Universitaria di Modena
Modena, Modena, 41100
Policlinico Casilino
Rome, Rome, 00100
About this study
Official title: Outcome of seCond Generation Drug-ELuting Stents in Patients With Diabetes Mellitus: cOmparison of Three differenT Drug Regimens
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
Read the 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.
- Conditions
- Coronary Artery Disease, Diabetes Mellitus
- Being tested
- Taxus Element stent, Integrity Resolute stent, Xience Prime stent
- Keywords
- Randomized controlled trial, Drug-eluting Stent, Multicenter study
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taxus Element stentDevice
Also called Taxus
paclitaxel-eluting stent
Integrity Resolute stentDevice
Also called Resolute Integrity
ABT 578-eluting stent
Xience Prime stentDevice
Also called Xience Prime
Everolimus-eluting stent
| Study group | Role | What they receive |
|---|---|---|
| Taxus Element | Active comparator | Patients treated with paclitaxel-eluting stent (Taxus Element, Boston Scientific, MN) Receives: Device: Taxus Element stent |
| Xience Prime | Active comparator | Patients treated with Everolimus-eluting stent (Xience Prime, Abbott, IL) Receives: Device: Xience Prime stent |
| Integrity Resolute | Active comparator | Patients treated with ABT 578-eluting stent (Integrity Resolute, Medtronic, MA) Receives: Device: Integrity Resolute stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (3)
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
Measured: 1 year
Target Lesion Revascularization
Target lesion revascularization at 12, 24 and 36 months
Measured: 1, 2 and 3 year
Effect of dual antiplatelet therapy on outcome
Comparison of 12-month versus prolonged (> 12-month) dual antiplatelet therapy on outcome
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study startOct 2010
- Primary completionOct 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Policlinico Casilino ASL RMB
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero-Universitaria di Modena
- Investigators
- Enrico Romagnoli, MD, PhD, Principal investigator, Policlinico Casilino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293773
- Sponsor's protocol ID
- 007/CE-RMB
- Acronym
- OCELOT
- Status last verified
- Aug 2011
- First submitted
- 10 Feb 2011
- Last updated
- 7 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of seCond Generation Drug-ELuting Stents in Patients With Diabetes Mellitus: cOmparison of Three differenT Drug Regimens
- ClinicalTrials.gov ID
- NCT01293773
- Acronym / sponsor ID
- OCELOT / 007/CE-RMB
- Conditions
- Coronary Artery Disease, Diabetes Mellitus
- Keywords
- Randomized controlled trial, Drug-eluting Stent, Multicenter study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Policlinico Casilino ASL RMBUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero-Universitaria di Modena
- Study start
- Oct 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Taxus Element | Active comparator | Device: Taxus Element stentPatients treated with paclitaxel-eluting stent (Taxus Element, Boston Scientific, MN) |
| Xience Prime | Active comparator | Device: Xience Prime stentPatients treated with Everolimus-eluting stent (Xience Prime, Abbott, IL) |
| Integrity Resolute | Active comparator | Device: Integrity Resolute stentPatients treated with ABT 578-eluting stent (Integrity Resolute, Medtronic, MA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taxus Element stentAlso: Taxuspaclitaxel-eluting stent | Device | Taxus Element |
| Integrity Resolute stentAlso: Resolute IntegrityABT 578-eluting stent | Device | Integrity Resolute |
| Xience Prime stentAlso: Xience PrimeEverolimus-eluting stent | Device | Xience Prime |
Primary outcome
Target lesion failure
Time frame: 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
3 secondary outcomes
Effect of glucose levels on repeat revascularization
Time frame: 1 year
Target Lesion Revascularization
Time frame: 1, 2 and 3 year
Effect of dual antiplatelet therapy on outcome
Time frame: 3 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enrico Romagnoli, MD, PhD principal investigator
Policlinico Casilino
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Taxus Element stent, Integrity Resolute stent and Xience Prime stent in people with Coronary Artery Disease and Diabetes Mellitus, run by Policlinico Casilino ASL RMB at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target lesion failure (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2014.