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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Conditions: Coronary Heart Disease
Coronary Restenosis
Interventions: Drug: Oral sirolimus
Device: Drug Eluting stent

  Participant Flow

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
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] 
Death                3                7 
[1] patients
[2] All patients were followed for 18.3 +/- 7 months.

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
 100   100   200 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   61   58   119 
>=65 years   39   42   81 
[Units: Years]
Mean (Standard Deviation)
 62.1  (10.1)   63.4  (10.6)   63.2  (10.4) 
[Units: Participants]
Female   17   19   36 
Male   83   81   164 
Region of Enrollment 
[Units: Participants]
Argentina   100   100   200 

  Outcome Measures

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

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

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


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 Submitted: November 1, 2007
First Posted: November 2, 2007
Results First Submitted: March 31, 2009
Results First Posted: August 20, 2009
Last Update Posted: June 2, 2010