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Coronary Artery DiseasePhase 2/3NCT00369356

Cortisone or Drug Eluting Stents (DES) as Compared to Bare Metal Stents (BMS) to EliminAte Restenosis

A Phase 2/3 study testing Prednisone, Drug eluting coronary stent and Bare metal coronary stent in people with Coronary Artery Disease and Ischemic Heart Disease, run by Universita di Verona at 5 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The possibility of using the new drug eluting stents (DES) technology has significantly changed the mid-term outcome of percutaneous coronary interventions (PCI) in terms of reduced recurrence of angina. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Prednisone, Drug eluting coronary stent and Bare metal coronary stent
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
375 participants
Where
5 sitesItaly
Study dates
Oct 2006to Jan 2011
Phase
Phase 2/3
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with diagnosed CAD (either SVD or MVD) with signs or symptoms of myocardial ischemia, scheduled for percutaneous revascularization are all candidates.
  • Either native vessels and SVG can be included with de-novo or recurrent lesions.
  • Lesions causing a diameter stenosis >50% in a main coronary artery (LAD, RCA, LCx) or their principal branches (Dg, OM, PL, PDA).

Who cannot join

  • Diabetes
  • Age over 80 years old
  • Recent Q wave myocardial infarction (less than 2 weeks)
  • Severe hypertension, uncontrolled despite medical treatment
  • Gastric ulcer or symptomatic gastritis
  • Neoplasia
Show all 10Show fewer
  • Renal failure (creatinine >2.5)
  • Left main disease, or left main equivalent (proximal LAD and proximal LCx), or three vessel disease involving the proximal segments of the 3 main coronary branches
  • Suboptimal angiographic result of PCI (DS% >30% or TIMI flow <grade 3)
  • Contraindications to high-doses of steroids (immunosuppression, active infective disease, osteoporosis, recent use of high doses of steroids).

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Italy5 sites

  • Istituto Clinico Humanitas

    Milan, Milano, 20089

  • Ospedale Maggiore della Carità

    Novara, Novara, 28100

  • European Hospital

    Rome, Rome, 00149

  • Ospedale San Giovanni Bosco

    Torino, Torino, 10100

  • Università di Verona

    Verona, Verona, 37126

Other trials in Italy

About this study

Official title: Clinical and Angiographic Outcome of Patients Treated With Bare Metal Stent (BMS) Implantation Compared With Drug Eluting Stents or BMS Plus Systemic Prednisone Therapy. A Randomized, Multicentre Study.

The possibility of using the new drug eluting stents (DES) technology has significantly changed the mid-term outcome of percutaneous coronary interventions (PCI) in terms of reduced recurrence of angina. The way interventionalists accomplish their work is changing accordingly, with a strong trend to a wider use of DES and a consequent perceived patients' clinical benefit.

Evidences supporting the superiority of DES in reducing ischemic recurrence after PCI compared to traditional stents (BMS) are available from randomized studies. A recent meta-analyses underlines that:

Read more

DES are superior to BMS in reducing clinical recurrence of ischemia, DES and BMS offer identical results in terms of death and infarction, Rapamycin and paclitaxel DES offer similar results.

The aim of our study is to perform a multicenter, randomized study to assess the clinical efficacy and safety of the oral prednisone therapy after PCI as a possible systemic alternative to currently available BMS and DES. Furthermore, the study aims at analyzing the clinical outcome of the commercially available DES in the context of an independent research and a cost-benefit comparison with BMS and oral steroids.

Read the detailed description

Design of the study

It is very important to underline that this is a "spontaneous" study, i.e. not receiving sponsorship from pharmaceutical industries, stent manufacturers, or any other financial source. This independence from economic interests would contribute to exclude conflicts of interest that may bias the results of the study that is aimed at testing the applicability and the clinical efficacy of this therapy. Furthermore, the assessment of the DES in public hospitals, and beyond the spectrum of the industry-supported studies may offer interesting results of the real life use of these devices.

One of the purposes of the study is a cost-effectiveness analysis. Centers participating in the study should therefore perform PCI according to their common practice with no interference in their decision-making process or technical approach to PCI because of the inclusion of the patients into a randomized study; this is aimed at obtaining an as real as possible situation of the daily practice. Being an spontaneous research, neither a fee will be provided for the enrollment of patients, nor free stents will be given.

The allocation of patients into a BMS or DES treatment will be decided by randomization, and the stents implanted will be selected according to the operator's preference.

The study will include three different groups of patients:

  • Control group: receiving BMS;
  • DES group: receiving DES;
  • Prednisone group: receiving BMS and oral prednisone

Principal objective of the study: is the comparison of the primary endpoint obtained in a control group of patients treated with BMS versus two alternative study groups:

  • DES
  • BMS and oral prednisone All assuming a similar adjunctive conventional medical treatment.

Secondary endpoint of the study are:

  • cost-effectiveness analysis. This will be calculated considering all patients enrolled in the study and analyzed after one year of the treatment. The analysis will take into account the procedural cost of the PCI material, the cost of the medical treatment in the first year of follow-up and the number of event-free days at follow-up. The cost-efficacy analysis will be obtained from the ratio between the cost of the event-free day of follow-up and the possibility of MACE considered in the primary endpoint of the study.
  • comparison of the angiographic results. This will be calculated in all patients enrolled.
Being tested
Prednisone, Drug eluting coronary stent, Bare metal coronary stent
Medical subject headings
Coronary Artery Disease, Myocardial Ischemia, Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrednisoneDrug

    Bare metal stenting with administration of oral prednisone as described in the protocol

  • Drug eluting coronary stentDevice

    Stenting with DES (Cypher or Taxus)

  • Bare metal coronary stentDevice

    Stenting with BMS only

Study groups in NCT00369356
Study groupRoleWhat they receive
1Sham comparatorBare Metal Stenting
Receives: Device: Bare metal coronary stent
2Active comparatorStenting with DES
Receives: Device: Drug eluting coronary stent
3ExperimentalBare metal stenting and administration of prednisone
Receives: Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of cardiac death, myocardial infarction, recurrence of angina at rest or need to repeat revascularization at 12 months.

    Measured: 12 months

Secondary outcomes (2)

  1. Angiographic restenosis according to the late loss measurement after 6 to 9 months of the procedure. A DS% =>50 at in-segment analysis will be considered as restenosis.

    Measured: 9 months

  2. Cost-efficacy analysis of the study at 12 months.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionOct 2009
  4. Study completionJan 2011

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
375 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00369356
Sponsor's protocol ID
CEREA-DES
Status last verified
Jan 2013
First submitted
24 Aug 2006
Last updated
23 Jan 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Versaci F, Gaspardone A, Tomai F, Ribichini F, Russo P, Proietti I, Ghini AS, Ferrero V, Chiariello L, Gioffre PA, Romeo F, Crea F; Immunosuppressive Therapy for the Prevention of Restenosis after Coronary Artery Stent Implantation Study. Immunosuppressive Therapy for the Prevention of Restenosis after Coronary Artery Stent Implantation (IMPRESS Study). J Am Coll Cardiol. 2002 Dec 4;40(11):1935-42. doi: 10.1016/s0735-1097(02)02562-7.

    PubMed 12475452

  • Ribichini F, Ferrero V, Agostini M, Vassanelli C. Immunosuppression against restenosis. Efficacy of a radiofrequency guidewire and oral prednisone in achieving and maintaining coronary artery patency after stenting. Cardiovasc Revasc Med. 2005 Jul-Sep;6(3):124-5. doi: 10.1016/j.carrev.2005.08.006. No abstract available.

    PubMed 16275609

  • Ferrero V, Ribichini F, Rognoni A, Marino P, Brunelleschi S, Vassanelli C. Comparison of efficacy and safety of lower-dose to higher-dose oral prednisone after percutaneous coronary interventions (the IMPRESS-LD study). Am J Cardiol. 2007 Apr 15;99(8):1082-6. doi: 10.1016/j.amjcard.2006.11.064. Epub 2007 Mar 6.

    PubMed 17437731

  • Ribichini F, Ferrero V, Rognoni A, Marino P, Brunelleschi S, Vassanelli C. Percutaneous treatment of coronary bifurcations: lesion preparation before provisional bare metal stenting and subsequent immunosuppression with oral prednisone. The IMPRESS-Y study. J Interv Cardiol. 2007 Apr;20(2):114-21. doi: 10.1111/j.1540-8183.2007.00250.x.

    PubMed 17391219

  • Ribichini F, Tomai F, Paloscia L, Di Sciascio G, Carosio G, Romano M, Verna E, Galli M, Tamburino C, De Cesare N, Pirisi R, Piscione F, Lanteri G, Ferrero V, Vassanelli C; DESIRE investigators. Steroid-eluting stents in patients with acute coronary syndrome: the dexamethasone eluting stent Italian registry. Heart. 2007 May;93(5):598-600. doi: 10.1136/hrt.2006.098467. Epub 2006 Sep 27.

    PubMed 17005712

  • Ribichini F, Joner M, Ferrero V, Finn AV, Crimins J, Nakazawa G, Acampado E, Kolodgie FD, Vassanelli C, Virmani R. Effects of oral prednisone after stenting in a rabbit model of established atherosclerosis. J Am Coll Cardiol. 2007 Jul 10;50(2):176-85. doi: 10.1016/j.jacc.2007.03.031. Epub 2007 Jun 22.

    PubMed 17616304

  • Ferrero V, Ribichini F, Pesarini G, Brunelleschi S, Vassanelli C. Glucocorticoids in the prevention of restenosis after coronary angioplasty: therapeutic potential. Drugs. 2007;67(9):1243-55. doi: 10.2165/00003495-200767090-00001.

    PubMed 17547469

  • Ribichini F, Tomai F, De Luca G, Boccuzzi G, Presbitero P, Pesarini G, Ferrero V, Ghini AS, Abukaresh R, Aurigemma C, De Luca L, Zavalloni D, Soregaroli D, Marino P, Garbo R, Zanolla L, Vassanelli C; CEREA-DES investigators. Immunosuppressive therapy with oral prednisone to prevent restenosis after PCI. A multicenter randomized trial. Am J Med. 2011 May;124(5):434-43. doi: 10.1016/j.amjmed.2010.11.027.

    PubMed 21531233

  • Ribichini F, Tomai F, Pesarini G, Zivelonghi C, Rognoni A, De Luca G, Boccuzzi G, Presbitero P, Ferrero V, Ghini AS, Marino P, Vassanelli C; CEREA-DES Investigators. Long-term clinical follow-up of the multicentre, randomized study to test immunosuppressive therapy with oral prednisone for the prevention of restenosis after percutaneous coronary interventions: Cortisone plus BMS or DES veRsus BMS alone to EliminAte Restenosis (CEREA-DES). Eur Heart J. 2013 Jun;34(23):1740-8. doi: 10.1093/eurheartj/eht079. Epub 2013 Mar 14.

    PubMed 23492671

  • Ribichini F, Tomai F, De Luca G, Boccuzzi G, Presbitero P, Pesarini G, Ferrero V, Ghini AS, Pastori F, De Luca L, Zavalloni D, Soregaroli D, Garbo R, Franchi E, Marino P, Minelli M, Vassanelli C. A multicenter, randomized study to test immunosuppressive therapy with oral prednisone for the prevention of restenosis after percutaneous coronary interventions: cortisone plus BMS or DES versus BMS alone to eliminate restenosis (CEREA-DES) - study design and rationale. J Cardiovasc Med (Hagerstown). 2009 Feb;10(2):192-9. doi: 10.2459/JCM.0b013e32831f9176.

    PubMed 19377384

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Prednisone, Drug eluting coronary stent and Bare metal coronary stent in people with Coronary Artery Disease and Ischemic Heart Disease, run by Universita di Verona at 5 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 3 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: finished, as of the sponsor's last update on 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Incidence of cardiac death, myocardial infarction, recurrence of angina at rest or need to repeat revascularization at 12 months. (time frame: 12 months). 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 NCT00369356, which also lists 10 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 23 Jan 2013.

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