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
Results First Received: March 31, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Conditions: Coronary Heart Disease
Coronary Restenosis
Interventions: Drug: Oral sirolimus
Device: Drug Eluting stent

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between January 2006 to September 2007 we enrolled 200 patients in the trial.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
From 1274 patients with coronary angiography, 789 met clinical inclusion criteria, from whom 102 have angiographic exclusion criteria. 487 were excluded for inability for percutaneous coronary intervention (PCI) with drug eluting stent (DES) deployment or refuse to participate in the study; thus 200 patients were included in this randomized trial.

Reporting Groups
  Description
Oral Sirolimus + Bare Metal Stent Oral sirolimus plus bare metal stent implantation
Drug Eluting Stents Any Drug Eluting Stents

Participant Flow:   Overall Study
    Oral Sirolimus + Bare Metal Stent     Drug Eluting Stents  
STARTED     100 [1]   100 [1]
COMPLETED     97 [2]   93 [2]
NOT COMPLETED     3     7  
Death                 3                 7  
[1] patients
[2] All patients were followed for 18.3 +/- 7 months.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Oral Sirolimus + Bare Metal Stent Oral sirolimus plus bare metal stent implantation
Drug Eluting Stents Any Drug Eluting Stents
Total Total of all reporting groups

Baseline Measures
    Oral Sirolimus + Bare Metal Stent     Drug Eluting Stents     Total  
Number of Participants  
[units: participants]
  100     100     200  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     61     58     119  
>=65 years     39     42     81  
Age  
[units: years]
Mean ± Standard Deviation
  62.1  ± 10.1     63.4  ± 10.6     63.2  ± 10.4  
Gender  
[units: participants]
     
Female     17     19     36  
Male     83     81     164  
Region of Enrollment  
[units: participants]
     
Argentina     100     100     200  



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   Major Adverse Cardiovascular Events (MACCE)   [ Time Frame: 18 Months ]

3.  Secondary:   Target Vessel Revascularization (TVR)   [ Time Frame: 18 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
It was an open label design. Multiple approved DES designs were used. Health Care system in Argentina differs from other world ones.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Alfredo Rodriguez, MD, PHD
Organization: Centro de Estudios en Cardiologia Intervencionista
phone: 541149648721
e-mail: rodrigueza@sanatorio-otamendi.com.ar


Publications:

Publications automatically indexed to this study:

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