利用血运重建和积极药物评估的临床结果
CSP #424 - 利用血运重建和积极药物评估的临床结果
研究概览
详细说明
主要假设:对于符合 AHA 工作组 I 级 PCI 指征的记录有心肌缺血的患者,PCI 加强化药物治疗的策略在降低全因死亡率或非致死性 MI 方面优于单独强化药物治疗。
次要假设:与单纯药物治疗相比,PCI 加药物治疗的资源利用和 QOL 比较以及急性冠状动脉综合征的住院治疗效果更好。
主要结果:全因死亡率、非致死性心肌梗死。
干预措施:所有患者都将接受强化药物治疗。 此外,其中一半将接受经皮冠状动脉介入治疗 (PCI)。
研究摘要:COURAGE 试验是一项大规模、多中心、随机对照试验,比较药物治疗和 PCI 联合药物治疗,支持“硬”临床终点。 有资格纳入 COURAGE 的患者将包括除非常高风险受试者以外的所有受试者,并将包括患有慢性心绞痛(加拿大心血管协会 [CCS] I-III 级)、近期无并发症 MI 和无症状(或“无症状”)心肌梗死的患者缺血。 患者可能患有单支或多支冠状动脉疾病,并且可能曾接受过搭桥手术或 PCI。 我们预计 3 年累计事件发生率分别为 16.4% 和 21%,绝对差异为 4.6% 或相对差异为 22%。 最短随访时间为 2 1/2 年,最长为 7 年,使用 0.05 水平的双侧显着性检验,并假设 3% 的交叉率然后 2% 然后 1% 每个 2从药物治疗到 PCI 的年数,以及 1% 的年失访率 这些事件发生率表明需要 2,270 的样本量来检验具有 85% 功效的假设。 15 个 VA、19 个美国非 VA 和 16 个加拿大站点参与了这项研究。 计划的研究持续时间为 7 年,包括 4 1/2 年的患者入组和 2 1/2 - 7 年的随访。 研究工作于 1999 年 1 月开始,招生于 1999 年 6 月开始。 数据和安全监测委员会批准将样本量减少到 2,270 名受试者,这基于增加随机化和随访的时间以及更新 MI 的定义以包括生物标志物阳性(肌钙蛋白)ACS。 登记已完成,共有 2,287 名患者登记。
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习地点
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Alberta
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Calgary、Alberta、加拿大、T2N 2T9
- Foothills Hospital - Calgary, Alberta - Can
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Edmonton、Alberta、加拿大、T6G 2B7
- University of Alberta Hospital
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British Columbia
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Vancouver、British Columbia、加拿大、V6Z 1Y6
- St Paul's Hospital, Vancouver - British Columbia
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New Brunswick
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St. John、New Brunswick、加拿大、E2L 4L2
- St. John Regional Hospital Facility
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Nova Scotia
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Halifax、Nova Scotia、加拿大、B3H 3A7
- Queen Elizabeth Ii Hsc, Halifax, Nova Scotia - Can
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Ontario
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Hamilton、Ontario、加拿大、L8L 2X2
- Hamilton General Hospital - Hamilton, Ont - Can
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London、Ontario、加拿大、N6A 5A5
- London Health Sciences Ctr - London, Ont - Can
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Mississauga、Ontario、加拿大、L5B 2P7
- Trillium Health Care
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Sudbury、Ontario、加拿大、P3E 2N8
- Sudbury Regional Hospital - Sudbury, Ontario
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Toronto、Ontario、加拿大、M5G 2C4
- University Health Network
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Toronto、Ontario、加拿大、M4N 3M5
- Sunnybrook HSC - Toronto, Ontario
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Toronto、Ontario、加拿大、M5B 1W8
- St. Michael'S Hospital, Toronto, Ontario - Can
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Quebec
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Montreal、Quebec、加拿大、H4J1C5
- Hôpital du Sacré-Coeur de Montréal
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Montreal、Quebec、加拿大、H1T 1C8
- Montreal Heart Institute - Montreal, Quebec - Can
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Arizona
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Scottsdale、Arizona、美国、85259
- Mayo Clinic Arizona
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Arkansas
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No. Little Rock、Arkansas、美国、72114-1706
- Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
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California
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Los Angeles、California、美国、90027
- Southern CA Kaiser Permanente Medical Group
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Sacramento、California、美国、95655
- VA Northern California HCS
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Connecticut
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Hartford、Connecticut、美国、06102-5037
- Hartford Hospital
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Delaware
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Newark、Delaware、美国、19718
- Christiana Care Health Systems-Newark, DE
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Florida
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Melbourne、Florida、美国、32901
- MIMA Century Research Associates - Melbourne, FL
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Tampa、Florida、美国、33612
- James A. Haley Veterans Hospital, Tampa
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Georgia
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Decatur、Georgia、美国、30033
- Atlanta VA Medical and Rehab Center, Decatur
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Illinois
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Chicago、Illinois、美国、60612
- Jesse Brown VAMC (WestSide Division)
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Iowa
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Davenport、Iowa、美国、52803-2498
- Genesis Medical Center
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Iowa City、Iowa、美国、52246-2208
- VA Medical Center, Iowa City
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Kentucky
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Lexington、Kentucky、美国、40502
- VA Medical Center, Lexington
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Maryland
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Baltimore、Maryland、美国、21201
- VA Maryland Health Care System, Baltimore
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Massachusetts
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Boston、Massachusetts、美国、02130
- VA Medical Center, Jamaica Plain Campus
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Michigan
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Ann Arbor、Michigan、美国、48113
- VA Ann Arbor Healthcare System
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Detroit、Michigan、美国、48201
- John D. Dingell VA Medical Center, Detroit
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Minnesota
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Rochester、Minnesota、美国、55905
- Mayo Clinic Rochester - Rochester, MN
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Missouri
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Kansas City、Missouri、美国、64128
- VA Medical Center, Kansas City MO
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St Louis、Missouri、美国、63106
- VA Medical Center, St Louis
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New Mexico
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Albuquerque、New Mexico、美国、87108-5153
- New Mexico VA Health Care System, Albuquerque
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New York
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New York、New York、美国、10010
- New York Harbor HCS
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Rochester、New York、美国、14642-8679
- University of Rochester Strong Memorial Hospital
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Syracuse、New York、美国、13210
- VA Medical Center, Syracuse
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North Carolina
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Durham、North Carolina、美国、27705
- VA Medical Center, Durham
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Ohio
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Cleveland、Ohio、美国、44106
- VA Medical Center, Cleveland
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Oklahoma
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Oklahoma City、Oklahoma、美国、73104
- VA Medical Center, Oklahoma City
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Oregon
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Portland、Oregon、美国、97201
- VA Medical Center, Portland
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- VA Medical Center, Philadelphia
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Tennessee
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Memphis、Tennessee、美国、38104
- VA Medical Center, Memphis
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Nashville、Tennessee、美国、37212-2637
- VA Medical Center
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Texas
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Houston、Texas、美国、77030
- Michael E. DeBakey VA Medical Center (152)
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San Antonio、Texas、美国、78229
- VA South Texas Health Care System, San Antonio
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Washington
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Seattle、Washington、美国、98108
- VA Puget Sound Health Care System, Seattle
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
纳入标准:
- 有资格纳入 COURAGE 的患者将包括除非常高风险受试者以外的所有受试者,并将包括患有慢性心绞痛(加拿大心血管学会 [CCS] I-III 级)、无并发症的 MI、冷却型 ACS 和无症状(或“无症状”)的患者") 心肌缺血。
- 患者可能患有单支或多支冠状动脉疾病,并且可能曾接受过搭桥手术或 PCI。
重要的是要强调,尽可能多的 CAD 患者类型——反映当代临床实践中遇到的患者范围——将被纳入 COURAGE。
排除标准:
学习计划
研究是如何设计的?
设计细节
- 分配:随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:1个
经皮冠状动脉介入治疗 (PCI) 加强化药物治疗
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有源比较器:2个
强化药物治疗
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合作者和调查者
合作者
调查人员
- 学习椅:William E. Boden、VA South Texas Health Care System, San Antonio
出版物和有用的链接
一般刊物
- Farkouh ME, Boden WE, Bittner V, Muratov V, Hartigan P, Ogdie M, Bertolet M, Mathewkutty S, Teo K, Maron DJ, Sethi SS, Domanski M, Frye RL, Fuster V. Risk factor control for coronary artery disease secondary prevention in large randomized trials. J Am Coll Cardiol. 2013 Apr 16;61(15):1607-15. doi: 10.1016/j.jacc.2013.01.044.
- Mancini GBJ, Maron DJ, Hartigan PM, Spertus JA, Kostuk WJ, Berman DS, Teo KK, Weintraub WS, Boden WE; COURAGE Trial Research Group. Lifestyle, Glycosylated Hemoglobin A1c, and Survival Among Patients With Stable Ischemic Heart Disease and Diabetes. J Am Coll Cardiol. 2019 Apr 30;73(16):2049-2058. doi: 10.1016/j.jacc.2018.11.067.
- Weintraub WS, Hartigan PM, Mancini GBJ, Teo KK, Maron DJ, Spertus JA, Chaitman BR, Shaw LJ, Berman D, Boden WE. Effect of Coronary Anatomy and Myocardial Ischemia on Long-Term Survival in Patients with Stable Ischemic Heart Disease. Circ Cardiovasc Qual Outcomes. 2019 Feb;12(2):e005079. doi: 10.1161/CIRCOUTCOMES.118.005079.
- Maron DJ, Mancini GBJ, Hartigan PM, Spertus JA, Sedlis SP, Kostuk WJ, Berman DS, Teo KK, Weintraub WS, Boden WE; COURAGE Trial Group. Healthy Behavior, Risk Factor Control, and Survival in the COURAGE Trial. J Am Coll Cardiol. 2018 Nov 6;72(19):2297-2305. doi: 10.1016/j.jacc.2018.08.2163.
- Zhang Z, Jones P, Weintraub WS, Mancini GBJ, Sedlis S, Maron DJ, Teo K, Hartigan P, Kostuk W, Berman D, Boden WE, Spertus JA. Predicting the Benefits of Percutaneous Coronary Intervention on 1-Year Angina and Quality of Life in Stable Ischemic Heart Disease: Risk Models From the COURAGE Trial (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation). Circ Cardiovasc Qual Outcomes. 2018 May;11(5):e003971. doi: 10.1161/CIRCOUTCOMES.117.003971.
- Sedlis SP, Hartigan PM, Teo KK, Maron DJ, Spertus JA, Mancini GB, Kostuk W, Chaitman BR, Berman D, Lorin JD, Dada M, Weintraub WS, Boden WE; COURAGE Trial Investigators. Effect of PCI on Long-Term Survival in Patients with Stable Ischemic Heart Disease. N Engl J Med. 2015 Nov 12;373(20):1937-46. doi: 10.1056/NEJMoa1505532.
- Mancini GBJ, Hartigan PM, Shaw LJ, Berman DS, Hayes SW, Bates ER, Maron DJ, Teo K, Sedlis SP, Chaitman BR, Weintraub WS, Spertus JA, Kostuk WJ, Dada M, Booth DC, Boden WE. Predicting outcome in the COURAGE trial (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation): coronary anatomy versus ischemia. JACC Cardiovasc Interv. 2014 Feb;7(2):195-201. doi: 10.1016/j.jcin.2013.10.017. Epub 2014 Jan 15.
- Mancini GB, Hartigan PM, Bates ER, Chaitman BR, Sedlis SP, Maron DJ, Kostuk WJ, Spertus JA, Teo KK, Dada M, Knudtson M, Berman DS, Booth DC, Boden WE, Weintraub WS. Prognostic importance of coronary anatomy and left ventricular ejection fraction despite optimal therapy: assessment of residual risk in the Clinical Outcomes Utilizing Revascularization and Aggressive DruG Evaluation Trial. Am Heart J. 2013 Sep;166(3):481-7. doi: 10.1016/j.ahj.2013.07.007. Epub 2013 Aug 2.
- Acharjee S, Boden WE, Hartigan PM, Teo KK, Maron DJ, Sedlis SP, Kostuk W, Spertus JA, Dada M, Chaitman BR, Mancini GB, Weintraub WS. Low levels of high-density lipoprotein cholesterol and increased risk of cardiovascular events in stable ischemic heart disease patients: A post-hoc analysis from the COURAGE Trial (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation). J Am Coll Cardiol. 2013 Nov 12;62(20):1826-33. doi: 10.1016/j.jacc.2013.07.051. Epub 2013 Aug 21.
- Spertus JA, Maron DJ, Cohen DJ, Kolm P, Hartigan P, Weintraub WS, Berman DS, Teo KK, Shaw LJ, Sedlis SP, Knudtson M, Aslan M, Dada M, Boden WE, Mancini GB; Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) Trial Investigators and Coordinators. Frequency, predictors, and consequences of crossing over to revascularization within 12 months of randomization to optimal medical therapy in the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial. Circ Cardiovasc Qual Outcomes. 2013 Jul;6(4):409-18. doi: 10.1161/CIRCOUTCOMES.113.000139. Epub 2013 Jul 9.
- Maron DJ, Hartigan PM, Neff DR, Weintraub WS, Boden WE; COURAGE Trial Investigators. Impact of adding ezetimibe to statin to achieve low-density lipoprotein cholesterol goal (from the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation [COURAGE] trial). Am J Cardiol. 2013 Jun 1;111(11):1557-62. doi: 10.1016/j.amjcard.2013.02.005. Epub 2013 Mar 25.
- Shaw LJ, Weintraub WS, Maron DJ, Hartigan PM, Hachamovitch R, Min JK, Dada M, Mancini GB, Hayes SW, O'Rourke RA, Spertus JA, Kostuk W, Gosselin G, Chaitman BR, Knudtson M, Friedman J, Slomka P, Germano G, Bates ER, Teo KK, Boden WE, Berman DS. Baseline stress myocardial perfusion imaging results and outcomes in patients with stable ischemic heart disease randomized to optimal medical therapy with or without percutaneous coronary intervention. Am Heart J. 2012 Aug;164(2):243-50. doi: 10.1016/j.ahj.2012.05.018.
- Mancini GB, Hartigan PM, Bates ER, Sedlis SP, Maron DJ, Spertus JA, Berman DS, Kostuk WJ, Shaw LJ, Weintraub WS, Teo KK, Dada M, Chaitman BR, O'Rourke RA, Boden WE; COURAGE Investigators and Coordinators. Angiographic disease progression and residual risk of cardiovascular events while on optimal medical therapy: observations from the COURAGE Trial. Circ Cardiovasc Interv. 2011 Dec 1;4(6):545-52. doi: 10.1161/CIRCINTERVENTIONS.110.960062. Epub 2011 Nov 1.
- Maron DJ, Boden WE, Spertus JA, Hartigan PM, Mancini GB, Sedlis SP, Kostuk WJ, Chaitman BR, Shaw LJ, Berman DS, Dada M, Teo KK, Weintraub WS, O'Rourke RA; COURAGE Trial Research Group. Impact of metabolic syndrome and diabetes on prognosis and outcomes with early percutaneous coronary intervention in the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial. J Am Coll Cardiol. 2011 Jul 5;58(2):131-7. doi: 10.1016/j.jacc.2011.02.046.
- Zhang Z, Kolm P, Boden WE, Hartigan PM, Maron DJ, Spertus JA, O'Rourke RA, Shaw LJ, Sedlis SP, Mancini GB, Berman DS, Dada M, Teo KK, Weintraub WS. The cost-effectiveness of percutaneous coronary intervention as a function of angina severity in patients with stable angina. Circ Cardiovasc Qual Outcomes. 2011 Mar;4(2):172-82. doi: 10.1161/CIRCOUTCOMES.110.940502. Epub 2011 Feb 8.
- Chaitman BR, Hartigan PM, Booth DC, Teo KK, Mancini GB, Kostuk WJ, Spertus JA, Maron DJ, Dada M, O'Rourke RA, Weintraub WS, Berman DS, Shaw LJ, Boden WE; Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial investigators. Do major cardiovascular outcomes in patients with stable ischemic heart disease in the clinical outcomes utilizing revascularization and aggressive drug evaluation trial differ by healthcare system? Circ Cardiovasc Qual Outcomes. 2010 Sep;3(5):476-83. doi: 10.1161/CIRCOUTCOMES.109.901579. Epub 2010 Jul 27.
- Maron DJ, Boden WE, O'Rourke RA, Hartigan PM, Calfas KJ, Mancini GB, Spertus JA, Dada M, Kostuk WJ, Knudtson M, Harris CL, Sedlis SP, Zoble RG, Title LM, Gosselin G, Nawaz S, Gau GT, Blaustein AS, Bates ER, Shaw LJ, Berman DS, Chaitman BR, Weintraub WS, Teo KK; COURAGE Trial Research Group. Intensive multifactorial intervention for stable coronary artery disease: optimal medical therapy in the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial. J Am Coll Cardiol. 2010 Mar 30;55(13):1348-58. doi: 10.1016/j.jacc.2009.10.062.
- Teo KK, Sedlis SP, Boden WE, O'Rourke RA, Maron DJ, Hartigan PM, Dada M, Gupta V, Spertus JA, Kostuk WJ, Berman DS, Shaw LJ, Chaitman BR, Mancini GB, Weintraub WS; COURAGE Trial Investigators. Optimal medical therapy with or without percutaneous coronary intervention in older patients with stable coronary disease: a pre-specified subset analysis of the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive druG Evaluation) trial. J Am Coll Cardiol. 2009 Sep 29;54(14):1303-8. doi: 10.1016/j.jacc.2009.07.013.
- Weintraub WS, Boden WE, Zhang Z, Kolm P, Zhang Z, Spertus JA, Hartigan P, Veledar E, Jurkovitz C, Bowen J, Maron DJ, O'Rourke R, Dada M, Teo KK, Goeree R, Barnett PG; Department of Veterans Affairs Cooperative Studies Program No. 424 (COURAGE Trial) Investigators and Study Coordinators. Cost-effectiveness of percutaneous coronary intervention in optimally treated stable coronary patients. Circ Cardiovasc Qual Outcomes. 2008 Sep;1(1):12-20. doi: 10.1161/CIRCOUTCOMES.108.798462.
- Weintraub WS, Spertus JA, Kolm P, Maron DJ, Zhang Z, Jurkovitz C, Zhang W, Hartigan PM, Lewis C, Veledar E, Bowen J, Dunbar SB, Deaton C, Kaufman S, O'Rourke RA, Goeree R, Barnett PG, Teo KK, Boden WE; COURAGE Trial Research Group; Mancini GB. Effect of PCI on quality of life in patients with stable coronary disease. N Engl J Med. 2008 Aug 14;359(7):677-87. doi: 10.1056/NEJMoa072771.
- Shaw LJ, Berman DS, Maron DJ, Mancini GB, Hayes SW, Hartigan PM, Weintraub WS, O'Rourke RA, Dada M, Spertus JA, Chaitman BR, Friedman J, Slomka P, Heller GV, Germano G, Gosselin G, Berger P, Kostuk WJ, Schwartz RG, Knudtson M, Veledar E, Bates ER, McCallister B, Teo KK, Boden WE; COURAGE Investigators. Optimal medical therapy with or without percutaneous coronary intervention to reduce ischemic burden: results from the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial nuclear substudy. Circulation. 2008 Mar 11;117(10):1283-91. doi: 10.1161/CIRCULATIONAHA.107.743963. Epub 2008 Feb 11.
- Boden WE, O'Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk WJ, Knudtson M, Dada M, Casperson P, Harris CL, Chaitman BR, Shaw L, Gosselin G, Nawaz S, Title LM, Gau G, Blaustein AS, Booth DC, Bates ER, Spertus JA, Berman DS, Mancini GB, Weintraub WS; COURAGE Trial Research Group. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med. 2007 Apr 12;356(15):1503-16. doi: 10.1056/NEJMoa070829. Epub 2007 Mar 26.
研究记录日期
研究主要日期
学习开始
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
强化药物治疗的临床试验
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St. Joseph's Healthcare HamiltonUnity Health Toronto; Ontario Ministry of Health and Long Term Care; Women's College Hospital; Toronto... 和其他合作者终止
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University of Applied Sciences and Arts of Southern...Vrije Universiteit Brussel; Universiteit Antwerpen; THIM - die internationale Hochschule für Physiotherapie完全的
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Abbott Medical Devices完全的