Coronary Artery DiseasePhase 3RACESNCT01182649
Everolimus Stent in Patients With Coronary Artery Disease (CAD)
A Phase 3 study testing coronary stent and stent in people with Coronary Artery Disease and Coronary Atherosclerosis, run by San Giuseppe Moscati Hospital at 1 site in Italy.
Trial summary
Aim of the study is to compare the everolimus eluting stent and sirolimus eluting stent in all comers PCI eligible patients Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease, Coronary Atherosclerosis
- What is being tested?
- coronary stent and stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2007to Jun 2010
- Phase
- Phase 3
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with coronary artery disease eligible for percutaneous coronary intervention (PCI)
Who cannot join
- Contraindication to dual antiplatelet therapy for 12 months
- Known allergy to sirolimus or everolimus
- Major surgical procedure planned within 1 month
- History, symptoms, or findings suggestive of aortic dissection.
- Participation in other trials
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Comparison of Everolimus Eluting Stents and Sirolimus Eluting Stent in Patients With Coronary Artery Disease
Aim of the study is to compare the everolimus eluting stent and sirolimus eluting stent in all comers PCI eligible patients
Read the detailed description
Compared with the currently available first-generation drug-eluting stents (DES), second-generation DES have been designed with the goal of improving safety and efficacy. Everolimus, a sirolimus analogue, is released from a open cell, thin-strut, cobalt-chromium frame. A significant reduction in cardiac events was noted in patients with the everolimus-eluting stent compared with those who had a paclitaxel-eluting stent. Sirolimus eluting stent was the first available drug eluting stent and is the most tested. Therefore the investigators compared the safety and efficacy of the everolimus-eluting and sirolimus eluting stents in unselected patients in real world practice.
- Conditions
- Coronary Artery Disease, Coronary Atherosclerosis
- Being tested
- coronary stent, stent
- Keywords
- Drug Eluting Stents, Everolimus Eluting Stent, Coronary Angioplasty
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary stentDevice
Also called XIENCE V drug eluting stent; Abbot Vascular USA
coronary angioplasty with stent implantation
stentDevice
Also called CYPHER drug eluting stent; Johnson & Johnson USA
coronary angioplasty with stent implantation
| Study group | Role | What they receive |
|---|---|---|
| EES Group | Experimental | Patients who received an everolimus eluting stent Receives: Device: coronary stent |
| SES Gruop | Active comparator | Patients who received a sirolimus eluting stent Receives: Device: stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Vessel Revascularization
Incidence of clinically driven target vessel revascularization at 2 year follow up
Measured: 2 year
Secondary outcomes (3)
cardiac death
incidence of death for cardiac causes at 2 year
Measured: 2 year
non fatal myocardial infarction
incidence of non fatal Q or non Q wave reinfarction at 2 year
Measured: 2 year
stent thrombosis
incidence of definite, probable or possible stent thrombosis at 2 year
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startMar 2007
- Primary completionDec 2008
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Giuseppe Moscati Hospital
- Sponsor type
- University, hospital or other
- Investigators
- EMILIO DI LORENZO, MD PhD, Principal investigator, DIVISION OF CARDIOLOGY AORN MOSCATI AVELLINO ITALY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182649
- Sponsor's protocol ID
- AOM_DES02
- Acronym
- RACES
- Status last verified
- May 2010
- First submitted
- 9 Aug 2010
- Last updated
- 17 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Stone GW, Rizvi A, Newman W, Mastali K, Wang JC, Caputo R, Doostzadeh J, Cao S, Simonton CA, Sudhir K, Lansky AJ, Cutlip DE, Kereiakes DJ; SPIRIT IV Investigators. Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease. N Engl J Med. 2010 May 6;362(18):1663-74. doi: 10.1056/NEJMoa0910496.
PubMed 20445180Kedhi E, Joesoef KS, McFadden E, Wassing J, van Mieghem C, Goedhart D, Smits PC. Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial. Lancet. 2010 Jan 16;375(9710):201-9. doi: 10.1016/S0140-6736(09)62127-9. Epub 2010 Jan 7.
PubMed 20060578Caixeta A, Leon MB, Lansky AJ, Nikolsky E, Aoki J, Moses JW, Schofer J, Morice MC, Schampaert E, Kirtane AJ, Popma JJ, Parise H, Fahy M, Mehran R. 5-year clinical outcomes after sirolimus-eluting stent implantation insights from a patient-level pooled analysis of 4 randomized trials comparing sirolimus-eluting stents with bare-metal stents. J Am Coll Cardiol. 2009 Sep 1;54(10):894-902. doi: 10.1016/j.jacc.2009.04.077.
PubMed 19712798Di Lorenzo E, Sauro R, Varricchio A, Capasso M, Lanzillo T, Manganelli F, Mariello C, Siano F, Pagliuca MR, Stanco G, Rosato G, De Luca G. Benefits of drug-eluting stents as compared to bare metal stent in ST-segment elevation myocardial infarction: four year results of the PaclitAxel or Sirolimus-Eluting stent vs bare metal stent in primary angiOplasty (PASEO) randomized trial. Am Heart J. 2009 Oct;158(4):e43-50. doi: 10.1016/j.ahj.2009.03.016.
PubMed 19781402
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Everolimus Eluting Stents and Sirolimus Eluting Stent in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01182649
- Acronym / sponsor ID
- RACES / AOM_DES02
- Conditions
- Coronary Artery Disease, Coronary Atherosclerosis
- Keywords
- Drug Eluting Stents, Everolimus Eluting Stent, Coronary Angioplasty
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- San Giuseppe Moscati HospitalUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 17 Aug 2010 (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.
Aim of the study is to compare the everolimus eluting stent and sirolimus eluting stent in all comers PCI eligible patients
Detailed description
Compared with the currently available first-generation drug-eluting stents (DES), second-generation DES have been designed with the goal of improving safety and efficacy. Everolimus, a sirolimus analogue, is released from a open cell, thin-strut, cobalt-chromium frame. A significant reduction in cardiac events was noted in patients with the everolimus-eluting stent compared with those who had a paclitaxel-eluting stent. Sirolimus eluting stent was the first available drug eluting stent and is the most tested. Therefore the investigators compared the safety and efficacy of the everolimus-eluting and sirolimus eluting stents in unselected patients in real world practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EES Group | Experimental | Device: coronary stentPatients who received an everolimus eluting stent |
| SES Gruop | Active comparator | Device: stentPatients who received a sirolimus eluting stent |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with coronary artery disease eligible for percutaneous coronary intervention (PCI)
Key exclusion criteria (6 listed)
- Contraindication to dual antiplatelet therapy for 12 months
- Known allergy to sirolimus or everolimus
- Major surgical procedure planned within 1 month
- History, symptoms, or findings suggestive of aortic dissection.
- Participation in other trials
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 |
|---|---|---|
| coronary stentAlso: XIENCE V drug eluting stent; Abbot Vascular USAcoronary angioplasty with stent implantation | Device | EES Group |
| stentAlso: CYPHER drug eluting stent; Johnson & Johnson USAcoronary angioplasty with stent implantation | Device | SES Gruop |
Primary outcome
Target Vessel Revascularization
Time frame: 2 year
Incidence of clinically driven target vessel revascularization at 2 year follow up
3 secondary outcomes
cardiac death
Time frame: 2 year
non fatal myocardial infarction
Time frame: 2 year
stent thrombosis
Time frame: 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2010.
- Background: PubMed 20445180Stone GW, Rizvi A, Newman W, Mastali K, Wang JC, Caputo R, Doostzadeh J, Cao S, Simonton CA, Sudhir K, Lansky AJ, Cutlip DE, Kereiakes DJ; SPIRIT IV Investigators. Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease. N Engl J Med. 2010 May 6;362(18):1663-74. doi: 10.1056/NEJMoa0910496.
- Background: PubMed 20060578Kedhi E, Joesoef KS, McFadden E, Wassing J, van Mieghem C, Goedhart D, Smits PC. Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial. Lancet. 2010 Jan 16;375(9710):201-9. doi: 10.1016/S0140-6736(09)62127-9. Epub 2010 Jan 7.
- Background: PubMed 19712798Caixeta A, Leon MB, Lansky AJ, Nikolsky E, Aoki J, Moses JW, Schofer J, Morice MC, Schampaert E, Kirtane AJ, Popma JJ, Parise H, Fahy M, Mehran R. 5-year clinical outcomes after sirolimus-eluting stent implantation insights from a patient-level pooled analysis of 4 randomized trials comparing sirolimus-eluting stents with bare-metal stents. J Am Coll Cardiol. 2009 Sep 1;54(10):894-902. doi: 10.1016/j.jacc.2009.04.077.
- Background: PubMed 19781402Di Lorenzo E, Sauro R, Varricchio A, Capasso M, Lanzillo T, Manganelli F, Mariello C, Siano F, Pagliuca MR, Stanco G, Rosato G, De Luca G. Benefits of drug-eluting stents as compared to bare metal stent in ST-segment elevation myocardial infarction: four year results of the PaclitAxel or Sirolimus-Eluting stent vs bare metal stent in primary angiOplasty (PASEO) randomized trial. Am Heart J. 2009 Oct;158(4):e43-50. doi: 10.1016/j.ahj.2009.03.016.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
EMILIO DI LORENZO, MD PhD principal investigator
DIVISION OF CARDIOLOGY AORN MOSCATI AVELLINO ITALY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing coronary stent and stent in people with Coronary Artery Disease and Coronary Atherosclerosis, run by San Giuseppe Moscati Hospital at 1 site 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 17 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Vessel Revascularization (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01182649, which also lists 4 linked publications.
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 17 Aug 2010.