Randomized Study of Oral Rapamycin Plus Bare Metal Stents
Information source: Centro de estudios en Cardiologia Intervencionista
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Heart Disease; Coronary Restenosis; Survival
Intervention: Oral sirolimus (Drug); Drug Eluting stent (Device)
Phase: Phase 4
Status: Completed
Sponsored by: Centro de estudios en Cardiologia Intervencionista Official(s) and/or principal investigator(s):
Alfredo E Rodriguez, MD PhD FACC, Study Chair, Affiliation: Departamento de Cardiologia Intervencionista, Sanatorio Otamendi
Carlos Fernandez Pereira, MD, Study Director, Affiliation: Departamento de Cardiologia Intervencionista, Sanatorio Otamendi
Summary
In a previous randomized comparison, oral sirolimus plus bare metal stents 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)we sought to compare differences
in overall cost with both revascularization strategies at one, two, three and five years of
follow up assuming that safety and efficacy clinical end points would be similar.
Clinical Details
Official title: Phase 4 Study of Randomized Comparison Among Oral Rapamycin Plus Bare Metal Stents Versus Drug Eluting Stents in de Novo Coronary Lesions.
Study design: Health Services Research, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Differences in procedural and follow up cost between Oral sirolimus plus BMS implantation versus and DES in de novo coronary lesions.
Secondary outcome: 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
Detailed description:
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).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: January 2006
Ending date: September 2007
Last updated: November 1, 2007
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