Study of Oral Rapamycin Plus Bare Metal Stents - Full Text View

Sponsor:	Centro de estudios en Cardiologia Intervencionista
Information provided by:	Centro de estudios en Cardiologia Intervencionista
ClinicalTrials.gov Identifier:	NCT00552669

Sponsor:

Centro de estudios en Cardiologia Intervencionista

Information provided by:

Centro de estudios en Cardiologia Intervencionista

ClinicalTrials.gov Identifier:

NCT00552669

Purpose

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.

Condition	Intervention	Phase
Coronary Heart Disease Coronary Restenosis	Drug: Oral sirolimus Device: Drug Eluting stent	Phase IV

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase 4 Study of Randomized Comparison Among Oral Rapamycin Plus Bare Metal Stents Versus Drug Eluting Stents in de Novo Coronary Lesions.

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Heart Diseases

Drug Information available for: Sirolimus

U.S. FDA Resources

Further study details as provided by Centro de estudios en Cardiologia Intervencionista:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Major Adverse Cardiovascular Events (MACCE) [ Time Frame: 18 Months ] [ Designated as safety issue: Yes ]
Target Vessel Revascularization (TVR) [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment:	200
Study Start Date:	January 2006
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Oral sirolimus plus bare metal stent implantation	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 .
B: Active Comparator Drug Eluting Stents	Device: Drug Eluting stent Any Drug eluting stent

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552669

Locations

Argentina
Sanatorio Otamendi y Miroli
Buenos Aires, Argentina, 1115
Argentina, Buenos Aires
Clinica IMA
Adrogue, Buenos Aires, Argentina, 1846
Sanatorio Las Lomas
San Isidro, Buenos Aires, Argentina, 1354

Sponsors and Collaborators

Centro de estudios en Cardiologia Intervencionista

Investigators

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Responsible Party:	Centro de Estudios en Cardiologia Intervencionista ( Alfredo E Rodriguez, MD, PHD, FACC, FSCAI )
Study ID Numbers:	1-Rodriguez, 01-CECI
Study First Received:	November 1, 2007
Results First Received:	March 31, 2009
Last Updated:	July 10, 2009
ClinicalTrials.gov Identifier:	NCT00552669 History of Changes
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica