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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00552669
Recruitment Status : Completed
First Posted : November 2, 2007
Results First Posted : August 20, 2009
Last Update Posted : June 2, 2010
Information provided by:
Centro de estudios en Cardiologia Intervencionista

Brief Summary:
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 or disease Intervention/treatment Phase
Coronary Heart Disease Coronary Restenosis Drug: Oral sirolimus Device: Drug Eluting stent Phase 4

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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 Start Date : January 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A--Oral Rapamycin plus BMS
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 .
Other Name: Oral rapamycine

Active Comparator: B -- Drug Eluting Stent
Drug Eluting Stents
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)

Primary Outcome Measures :
  1. 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 ]
    Overall costs expressed in US dollars at 18 months of follow up between Oral Sirolimus Plus BMS vs DES implantation in denovo coronary lesions.

Secondary Outcome Measures :
  1. Major Adverse Cardiovascular Events (MACCE) [ Time Frame: 18 Months ]
    Death from any cause, myocardial infarction and stroke. Safety was analyzed as MACCE (major adverse cardiovascular events) including death, MI and stroke.

  2. Target Vessel Revascularization (TVR) [ Time Frame: 18 months ]
    Efficacy end point was TVR as revasacularization of the treated vessel.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00552669

Clinica IMA
Adrogue, Buenos Aires, Argentina, 1846
Sanatorio Las Lomas
San Isidro, Buenos Aires, Argentina, 1354
Sanatorio Otamendi y Miroli
Buenos Aires, Argentina, 1115
Sponsors and Collaborators
Centro de estudios en Cardiologia Intervencionista
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

Additional Information:

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Alfredo E Rodriguez, MD, PHD, FACC, FSCAI, Centro de Estudios en Cardiologia Intervencionista Identifier: NCT00552669     History of Changes
Other Study ID Numbers: 1-Rodriguez
01-CECI ( Other Identifier: Sanatorio Otamendi y Miroli, Buenos Aires, Argentina )
02-IMA ( Other Identifier: Clinica IMA, Buenos Aires, Argentina )
First Posted: November 2, 2007    Key Record Dates
Results First Posted: August 20, 2009
Last Update Posted: June 2, 2010
Last Verified: May 2009

Keywords provided by Centro de estudios en Cardiologia Intervencionista:
Drug Eluting Stents
Stents Bare Metal
Stent Thrombosis
Coronary revascularization

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Coronary Restenosis
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Coronary Stenosis
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs