Study of Oral Rapamycin Plus Bare Metal Stents vs Drug Eltuting Stents (ORAR III)
2010년 5월 27일 업데이트: 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.
연구 개요
상세 설명
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).
연구 유형
중재적
등록 (실제)
200
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Buenos Aires, 아르헨티나, 1115
- Sanatorio Otamendi y Miroli
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Buenos Aires
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Adrogue, Buenos Aires, 아르헨티나, 1846
- Clinica IMA
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San Isidro, Buenos Aires, 아르헨티나, 1354
- Sanatorio Las Lomas
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: A--Oral Rapamycin plus BMS
Oral sirolimus plus bare metal stent implantation
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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 .
다른 이름들:
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활성 비교기: B -- Drug Eluting Stent
Drug Eluting Stents
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Any Drug eluting stent
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Differences in Costs Between Two Revascularization Strategies for de Novo Coronary Lesions.
기간: Follow up will be conducted by the coordinating Center at 18 months of follow up
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Overall costs expressed in US dollars at 18 months of follow up between Oral Sirolimus Plus BMS vs DES implantation in denovo coronary lesions.
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Follow up will be conducted by the coordinating Center at 18 months of follow up
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Major Adverse Cardiovascular Events (MACCE)
기간: 18 Months
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Death from any cause, myocardial infarction and stroke.
Safety was analyzed as MACCE (major adverse cardiovascular events) including death, MI and stroke.
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18 Months
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Target Vessel Revascularization (TVR)
기간: 18 months
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Efficacy end point was TVR as revasacularization of the treated vessel.
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18 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Alfredo E Rodriguez, MD PhD FACC, Departamento de Cardiologia Intervencionista, Sanatorio Otamendi
- 연구 책임자: Carlos Fernandez Pereira, MD, Departamento de Cardiologia Intervencionista, Sanatorio Otamendi
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Stone GW, Ellis SG, Cannon L, Mann JT, Greenberg JD, Spriggs D, O'Shaughnessy CD, DeMaio S, Hall P, Popma JJ, Koglin J, Russell ME; TAXUS V Investigators. Comparison of a polymer-based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease: a randomized controlled trial. JAMA. 2005 Sep 14;294(10):1215-23. doi: 10.1001/jama.294.10.1215.
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- Colombo A, Drzewiecki J, Banning A, Grube E, Hauptmann K, Silber S, Dudek D, Fort S, Schiele F, Zmudka K, Guagliumi G, Russell ME; TAXUS II Study Group. Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions. Circulation. 2003 Aug 19;108(7):788-94. doi: 10.1161/01.CIR.0000086926.62288.A6. Epub 2003 Aug 4.
- Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, Kutys R, Skorija K, Gold HK, Virmani R. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol. 2006 Jul 4;48(1):193-202. doi: 10.1016/j.jacc.2006.03.042. Epub 2006 May 5.
- Morice MC, Colombo A, Meier B, Serruys P, Tamburino C, Guagliumi G, Sousa E, Stoll HP; REALITY Trial Investigators. Sirolimus- vs paclitaxel-eluting stents in de novo coronary artery lesions: the REALITY trial: a randomized controlled trial. JAMA. 2006 Feb 22;295(8):895-904. doi: 10.1001/jama.295.8.895.
- Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, Kukreja N, Juni P, Sianos G, Hellige G, van Domburg RT, Hess OM, Boersma E, Meier B, Windecker S, Serruys PW. Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet. 2007 Feb 24;369(9562):667-78. doi: 10.1016/S0140-6736(07)60314-6.
- Pfisterer M, Brunner-La Rocca HP, Buser PT, Rickenbacher P, Hunziker P, Mueller C, Jeger R, Bader F, Osswald S, Kaiser C; BASKET-LATE Investigators. Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: an observational study of drug-eluting versus bare-metal stents. J Am Coll Cardiol. 2006 Dec 19;48(12):2584-91. doi: 10.1016/j.jacc.2006.10.026. Epub 2006 Nov 2.
- Ho PM, Peterson ED, Wang L, Magid DJ, Fihn SD, Larsen GC, Jesse RA, Rumsfeld JS. Incidence of death and acute myocardial infarction associated with stopping clopidogrel after acute coronary syndrome. JAMA. 2008 Feb 6;299(5):532-9. doi: 10.1001/jama.299.5.532. Erratum In: JAMA. 2008 May 28;299(20):2390.
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- Poon M, Marx SO, Gallo R, Badimon JJ, Taubman MB, Marks AR. Rapamycin inhibits vascular smooth muscle cell migration. J Clin Invest. 1996 Nov 15;98(10):2277-83. doi: 10.1172/JCI119038.
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- Rodriguez AE, Mieres J, Fernandez-Pereira C, Vigo CF, Rodriguez-Alemparte M, Berrocal D, Grinfeld L, Palacios I. Coronary stent thrombosis in the current drug-eluting stent era: insights from the ERACI III trial. J Am Coll Cardiol. 2006 Jan 3;47(1):205-7. doi: 10.1016/j.jacc.2005.10.016. Epub 2005 Dec 9. No abstract available.
- Hausleiter J, Kastrati A, Mehilli J, Vogeser M, Zohlnhofer D, Schuhlen H, Goos C, Pache J, Dotzer F, Pogatsa-Murray G, Dirschinger J, Heemann U, Schomig A; OSIRIS Investigators. Randomized, double-blind, placebo-controlled trial of oral sirolimus for restenosis prevention in patients with in-stent restenosis: the Oral Sirolimus to Inhibit Recurrent In-stent Stenosis (OSIRIS) trial. Circulation. 2004 Aug 17;110(7):790-5. doi: 10.1161/01.CIR.0000138935.17503.35. Epub 2004 Aug 9.
- Rodriguez AE, Granada JF, Rodriguez-Alemparte M, Vigo CF, Delgado J, Fernandez-Pereira C, Pocovi A, Rodriguez-Granillo AM, Schulz D, Raizner AE, Palacios I, O'Neill W, Kaluza GL, Stone G; ORAR II Investigators. Oral rapamycin after coronary bare-metal stent implantation to prevent restenosis: the Prospective, Randomized Oral Rapamycin in Argentina (ORAR II) Study. J Am Coll Cardiol. 2006 Apr 18;47(8):1522-9. doi: 10.1016/j.jacc.2005.12.052. Epub 2006 Mar 29.
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- Rodriguez AE, Alemparte MR, Vigo CF, Pereira CF, Llaurado C, Russo M, Virmani R, Ambrose JA. Pilot study of oral rapamycin to prevent restenosis in patients undergoing coronary stent therapy: Argentina Single-Center Study (ORAR Trial). J Invasive Cardiol. 2003 Oct;15(10):581-4.
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- Rodriguez AE, Maree AO, Mieres J, Berrocal D, Grinfeld L, Fernandez-Pereira C, Curotto V, Rodriguez-Granillo A, O'Neill W, Palacios IF. Late loss of early benefit from drug-eluting stents when compared with bare-metal stents and coronary artery bypass surgery: 3 years follow-up of the ERACI III registry. Eur Heart J. 2007 Sep;28(17):2118-25. doi: 10.1093/eurheartj/ehm297. Epub 2007 Jul 25.
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- Cohen DJ, Bakhai A, Shi C, Githiora L, Lavelle T, Berezin RH, Leon MB, Moses JW, Carrozza JP Jr, Zidar JP, Kuntz RE; SIRIUS Investigators. Cost-effectiveness of sirolimus-eluting stents for treatment of complex coronary stenoses: results from the Sirolimus-Eluting Balloon Expandable Stent in the Treatment of Patients With De Novo Native Coronary Artery Lesions (SIRIUS) trial. Circulation. 2004 Aug 3;110(5):508-14. doi: 10.1161/01.CIR.0000136821.99814.43. Epub 2004 Jul 19.
- Bakhai A, Stone GW, Mahoney E, Lavelle TA, Shi C, Berezin RH, Lahue BJ, Clark MA, Lacey MJ, Russell ME, Ellis SG, Hermiller JB, Cox DA, Cohen DJ; TAXUS-IV Investigators. Cost effectiveness of paclitaxel-eluting stents for patients undergoing percutaneous coronary revascularization: results from the TAXUS-IV Trial. J Am Coll Cardiol. 2006 Jul 18;48(2):253-61. doi: 10.1016/j.jacc.2006.02.063. Epub 2006 Jun 22.
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- Rodriguez AE, Rodriguez-Granillo AM, Antoniucci D, Mieres J, Fernandez-Pereira C, Rodriguez-Granillo GA, Santaera O, Rubilar B, Palacios IF, Serruys PW; ORAR III Investigators. Randomized comparison of cost-saving and effectiveness of oral rapamycin plus bare-metal stents with drug-eluting stents: three-year outcome from the randomized oral rapamycin in Argentina (ORAR) III trial. Catheter Cardiovasc Interv. 2012 Sep 1;80(3):385-94. doi: 10.1002/ccd.23352. Epub 2011 Dec 8.
- Rodriguez AE, Maree A, Tarragona S, Fernandez-Pereira C, Santaera O, Rodriguez Granillo AM, Rodriguez-Granillo GA, Russo-Felssen M, Kukreja N, Antoniucci D, Palacios IF, Serruys PW; ORAR III Investigators. Percutaneous coronary intervention with oral sirolimus and bare metal stents has comparable safety and efficacy to treatment with drug eluting stents, but with significant cost saving: long-term follow-up results from the randomised, controlled ORAR III (Oral Rapamycin in ARgentina) study. EuroIntervention. 2009 Jun;5(2):255-64. doi: 10.4244/eijv5i2a40.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2006년 1월 1일
기본 완료 (실제)
2007년 9월 1일
연구 완료 (실제)
2007년 9월 1일
연구 등록 날짜
최초 제출
2007년 11월 1일
QC 기준을 충족하는 최초 제출
2007년 11월 1일
처음 게시됨 (추정)
2007년 11월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2010년 6월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2010년 5월 27일
마지막으로 확인됨
2009년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 1-Rodriguez
- 01-CECI (기타 식별자: Sanatorio Otamendi y Miroli, Buenos Aires, Argentina)
- 02-IMA (기타 식별자: Clinica IMA, Buenos Aires, Argentina)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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Medical University of BialystokInstitute of Cardiology, Warsaw, Poland; Medical University of Lodz; Poznan University of... 그리고 다른 협력자들아직 모집하지 않음심부전, 수축기 | 박출률이 감소된 심부전 | 심부전 New York Heart Association Class IV | 심부전 New York Heart Association Class III폴란드
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Hospital Clinic of BarcelonaAstraZeneca완전한CTO(Chronic Total Occlusion)를 위한 PCI(Percutaneous Coronary Intervention)를 받을 예정인 환자스페인
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Novartis Pharmaceuticals완전한핵심 연구의 12개월 치료 기간을 성공적으로 완료한 환자(de Novo Heart Recipients)는 EC-MPS 치료에 관심이 있었습니다.
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University of WashingtonAmerican Heart Association완전한심부전，울혈 | 미토콘드리아 변경 | 심부전 New York Heart Association Class IV미국
Oral sirolimus에 대한 임상 시험
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Federal University of the Valleys of Jequitinhonha...완전한
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Biomedical Development CorporationNational Heart, Lung, and Blood Institute (NHLBI); University of Kentucky알려지지 않은
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Aadi Bioscience, Inc.마케팅 승인TSC1 | TSC2 | 페코마, 악성 | mTOR 경로 이상
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University of Wisconsin, MadisonNational Institute on Aging (NIA)모병
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Meril Life Sciences Pvt. Ltd.Lifecare Institute of Medical Sciences and Research Ahmedabad Gujarat India완전한
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Inje University완전한