Study of Oral Rapamycin Plus Bare Metal Stents vs Drug Eltuting Stents (ORAR III)
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|ClinicalTrials.gov Identifier: NCT00552669|
Recruitment Status : Completed
First Posted : November 2, 2007
Results First Posted : August 20, 2009
Last Update Posted : June 2, 2010
|Condition or disease||Intervention/treatment||Phase|
|Coronary Heart Disease Coronary Restenosis||Drug: Oral sirolimus Device: Drug Eluting stent||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|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|
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
- 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.
- 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.
- Target Vessel Revascularization (TVR) [ Time Frame: 18 months ]Efficacy end point was TVR as revasacularization of the treated vessel.
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 ClinicalTrials.gov identifier (NCT number): NCT00552669
|Adrogue, Buenos Aires, Argentina, 1846|
|Sanatorio Las Lomas|
|San Isidro, Buenos Aires, Argentina, 1354|
|Sanatorio Otamendi y Miroli|
|Buenos Aires, Argentina, 1115|
|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|