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

This study has been completed.
Sponsor:
Collaborator:
Regione Piemonte
Information provided by (Responsible Party):
Flavio Ribichini, Universita di Verona
ClinicalTrials.gov Identifier:
NCT00369356
First received: August 24, 2006
Last updated: January 20, 2013
Last verified: January 2013
  Purpose

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:

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.


Condition Intervention Phase
Coronary Artery Disease
Ischemic Heart Disease
Atherosclerosis
Drug: Prednisone
Device: Drug eluting coronary stent
Device: Bare metal coronary stent
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Universita di Verona:

Primary Outcome Measures:
  • Incidence of cardiac death, myocardial infarction, recurrence of angina at rest or need to repeat revascularization at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Cost-efficacy analysis of the study at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 375
Study Start Date: October 2006
Study Completion Date: January 2011
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: 1
Bare Metal Stenting
Device: Bare metal coronary stent
Stenting with BMS only
Active Comparator: 2
Stenting with DES
Device: Drug eluting coronary stent
Stenting with DES (Cypher or Taxus)
Experimental: 3
Bare metal stenting and administration of prednisone
Drug: Prednisone
Bare metal stenting with administration of oral prednisone as described in the protocol

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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
  • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369356

Locations
Italy
Istituto Clinico Humanitas
Milano, Italy, 20089
Ospedale Maggiore della Carità
Novara, Italy, 28100
European Hospital
Rome, Italy, 00149
Ospedale San Giovanni Bosco
Torino, Italy, 10100
Università di Verona
Verona, Italy, 37126
Sponsors and Collaborators
Universita di Verona
Regione Piemonte
Investigators
Study Chair: Corrado Vassanelli, MD Università di Verona
Study Director: Flavio Ribichini, MD Università di Verona
Principal Investigator: Valeria Ferrero, MD Università di Verona
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Flavio Ribichini, MD, Universita di Verona
ClinicalTrials.gov Identifier: NCT00369356     History of Changes
Other Study ID Numbers: CEREA-DES
Study First Received: August 24, 2006
Last Updated: January 20, 2013
Health Authority: Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Prednisone
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 22, 2014