Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


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 ]
    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:
  • 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.


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
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)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Argentina
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
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
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alfredo E Rodriguez, MD, PHD, FACC, FSCAI, Centro de Estudios en Cardiologia Intervencionista
ClinicalTrials.gov Identifier: NCT00552669     History of Changes
Other Study ID Numbers: 1-Rodriguez, 01-CECI, 02-IMA
Study First Received: November 1, 2007
Results First Received: March 31, 2009
Last Updated: May 27, 2010
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

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

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

ClinicalTrials.gov processed this record on November 25, 2014