CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 375 enrolled
Drug / intervention
Prednisone +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00369356
NCT00369356Phase 3Completed

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.

Universita di Verona·interventional·Posted Aug 29, 2006·Updated Jan 23, 2013

In Brief

A Phase 3 clinical trial evaluating Prednisone, Drug eluting coronary stent, and 1 other intervention for Coronary Artery Disease and 2 related conditions. Completed, enrolled 375 participants across 5 sites.

Detailed 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. 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
CollaboratorsRegione Piemonte

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 29, 2006
Enrollment StartOct 1, 2006
Primary CompletionOct 1, 2009
Study CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 19.8 years ago

Interventions

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