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

May 27, 2010 updated by: Centro de estudios en Cardiologia Intervencionista

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Follow up will be conducted by the coordinating Center at 18 months of follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 Months
Target Vessel Revascularization (TVR)
Time Frame: 18 months
Efficacy end point was TVR as revasacularization of the treated vessel.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

November 1, 2007

First Submitted That Met QC Criteria

November 1, 2007

First Posted (Estimate)

November 2, 2007

Study Record Updates

Last Update Posted (Estimate)

June 2, 2010

Last Update Submitted That Met QC Criteria

May 27, 2010

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Heart Disease

Clinical Trials on Oral sirolimus

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe