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Study of Oral Rapamycin Plus Bare Metal Stents vs Drug Eltuting Stents (ORAR III)

This study has been completed.
Sponsor:
Information provided by:
Centro de estudios en Cardiologia Intervencionista
ClinicalTrials.gov Identifier:
NCT00552669
First received: November 1, 2007
Last updated: May 27, 2010
Last verified: May 2009

November 1, 2007
May 27, 2010
January 2006
September 2007   (final data collection date for primary outcome measure)
Differences in Costs Between Two Revascularization Strategies for de Novo Coronary Lesions. [ Time Frame: Follow up will be conducted by the coordinating Center at 18 months of follow up ] [ Designated as safety issue: No ]
Overall costs expressed in US dollars at 18 months of follow up between Oral Sirolimus Plus BMS vs DES implantation in denovo coronary lesions.
Differences in procedural and follow up cost between Oral sirolimus plus BMS implantation versus and DES in de novo coronary lesions. [ Time Frame: Follow up will be conducted by the coordinating Center at one ,two,three and five years of follow up ]
Complete list of historical versions of study NCT00552669 on ClinicalTrials.gov Archive Site
  • Major Adverse Cardiovascular Events (MACCE) [ Time Frame: 18 Months ] [ Designated as safety issue: Yes ]
    Death from any cause, myocardial infarction and stroke. Safety was analyzed as MACCE (major adverse cardiovascular events) including death, MI and stroke.
  • Target Vessel Revascularization (TVR) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Efficacy end point was TVR as revasacularization of the treated vessel.
Death from any cause,myocardial infarction and stroke. Safety was analyzed as MACCE(major adverse cardiovascular events)including death,MI and stroke.Efficacy end point was Target Vessel and Target Lesion Revascularization [ Time Frame: Al secondary safety and efficacy end points was analyzed at one ,two,three and five years of follow up ]
Not Provided
Not Provided
 
Study of Oral Rapamycin Plus Bare Metal Stents vs Drug Eltuting Stents
Phase 4 Study of Randomized Comparison Among Oral Rapamycin Plus Bare Metal Stents Versus Drug Eluting Stents in de Novo Coronary Lesions.

In a previous randomized comparison oral sirolimus plus bare metal stent compared to bare metal stent implantation alone demonstrated at one year of follow up a significant reduction of angiographic and clinical parameters of restenosis (ANMAT resolution number 3366 from June 2004 and Rodriguez A et al JACC,2006,47,1522-1529). In addition previous reported registries from our group with Drug Eluting Stents showed similar amount of reduction in clinical parameters (not angiographic)of restenosis (ERACI III, Rodriguez A et al EuroIntervention 2006,2:53-60). Taking in account that 8.3% of patients treated with oral rapamycin plus Bare Metal Stents(ORAR II Trial JACC 2006)and 8.8% of patients treated with DES developed clinical restenosis (ERACI III Registry, EuroIntervention 2006) the investigators sought to compare differences in overall cost with both revascularization strategies at 1, 2, 3 and 5 years of follow up assuming that safety and efficacy clinical end points would be similar.

Patients with de novo lesions treated in different Institutions in Buenos Aires Argentina were randomized to treat with oral sirolimus plus bare metal stent implantation (100 patients) or DES(100 patients).

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Coronary Heart Disease
  • Coronary Restenosis
  • Drug: Oral sirolimus
    Oral sirolimus given orally during 14 days plus bare metal stent implantation was compared with DES.Oral sirolimus was given as bolus of 10 mg started day before intervention followed by 3mg per day during 13 days after PCI. 180 mg of Diltiazem was added during oral administration of sirolimus .
    Other Name: Oral rapamycine
  • Device: Drug Eluting stent
    Any Drug eluting stent
    Other Names:
    • DES=Drug Eluting Stents)
    • PES (Paclitaxel Eluting Stent)
    • SES (Sirolimus eluting stent)
    • ZES (Zotarolimus eluting stent)
  • Experimental: A--Oral Rapamycin plus BMS
    Oral sirolimus plus bare metal stent implantation
    Intervention: Drug: Oral sirolimus
  • Active Comparator: B -- Drug Eluting Stent
    Drug Eluting Stents
    Intervention: Device: Drug Eluting stent

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
September 2007
September 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Indication of revascularization
  • De novo lesions
  • Native vessels
  • Suitable for stent placement

Exclusion Criteria:

  • Acute myocardial infarction within the last 24 hours
  • In stent restenosis
  • Previous percutaneous coronary intervention within the last 6 months
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina
 
NCT00552669
1-Rodriguez, 01-CECI, 02-IMA
Yes
Alfredo E Rodriguez, MD, PHD, FACC, FSCAI, Centro de Estudios en Cardiologia Intervencionista
Centro de estudios en Cardiologia Intervencionista
Not Provided
Study Chair: Alfredo E Rodriguez, MD PhD FACC Departamento de Cardiologia Intervencionista, Sanatorio Otamendi
Study Director: Carlos Fernandez Pereira, MD Departamento de Cardiologia Intervencionista, Sanatorio Otamendi
Centro de estudios en Cardiologia Intervencionista
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP