协调急性心肌梗死血运重建和支架的结果
2017年11月30日 更新者:Cardiovascular Research Foundation, New York
在 ST 段抬高 AMI 患者中进行双臂因子随机试验,比较使用抗凝治疗与普通肝素 + 常规 GP IIb/IIIa 抑制或比伐卢定 + 纾缓 GP IIb/IIIa 抑制的结果;使用慢速释放紫杉醇洗脱支架 (TAXUS™) 或未涂层裸金属支架 (EXPRESS2™) 进行支架植入术和一期血管成形术
试验的主要目标是:
- 在接受主要血管成形术策略的急性心肌梗死患者中,与使用普通肝素 + GP IIb/IIIa 抑制剂相比,确定使用比伐卢定(+ GP IIb/IIIa 抑制剂)的安全性和有效性。
- 与其他方面相同的未涂层裸金属 EXPRESS2™ 支架相比,确定慢速释放紫杉醇洗脱 TAXUS™ 支架的安全性和有效性。
研究概览
详细说明
前瞻性、2 x 2 因子单盲、随机、多中心试验,在多达 200 个中心招募了 3400 名患者。
患者将在急诊室以 1:1 的比例随机分配至 a) 使用普通肝素抗凝加常规 GP IIb/IIIa 抑制与 b) 比伐卢定和缓解 GP IIb/IIIa 抑制。
血管造影后,病变符合支架置入条件的患者将接受第二次随机化 (3:1) 支架植入,a) 缓慢释放紫杉醇洗脱支架 (TAXUS™) 或 b) 其他方面相同的未涂层裸金属支架(EXPRESS2™)。
研究类型
介入性
注册 (实际的)
3602
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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North Carolina
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Greensboro、North Carolina、美国、27401
- LeBauer CV Research Foundation
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准:
- 必须具有与 AMI 一致的临床症状(例如,心绞痛或心绞痛等同物)持续时间 >20 分钟但<12 小时;
- >2 个相邻导联中的 ST 段抬高 >1 毫米,或(可能是新的)左束支传导阻滞,或真性后壁心梗伴 >2 个相邻前部导联中的 ST 段压低 >1 毫米;
- 患者或监护人同意研究方案以及临床和血管造影随访的时间表,并提供知情的书面同意。
排除标准:
患者已知对以下任何药物过敏或禁忌:
- 肝素、猪肉或猪肉制品
- 阿昔单抗和依替巴肽
- 阿司匹林
- 氯吡格雷和噻氯匹定
- 比伐卢定
- 紫杉醇或紫杉醇
- TAXUS™ 支架 (SIBS) 的聚合物成分
- 不锈钢和/或
- 对比媒体;
- 本次入院之前接受过溶栓治疗、比伐卢定、GP IIb/IIIa 抑制剂、低分子肝素或磺达肝素。 之前接受过普通肝素治疗的患者可以入组,并根据随机分组进行治疗;
- 目前使用香豆素;
- 全身(静脉内)紫杉醇或紫杉醇在 12 个月内使用;
- 有生育潜力的女性,除非最近的妊娠试验为阴性,否则可能计划在参加本研究后随时怀孕;
- 有出血素质或已知凝血病史(包括肝素诱导的血小板减少症),或拒绝输血;
- 脑内肿块、动脉瘤、动静脉畸形或出血性中风病史;
- 过去 6 个月内中风或短暂性脑缺血发作,或任何永久性残余神经缺陷;
- 最近 2 个月内胃肠道或泌尿生殖系统出血,或六周内进行过大手术;
- 近期病史或已知的当前血小板计数 <100,000 个细胞/mm3 或 Hgb <10 g/dL;
- 广泛的外周血管疾病,使得研究者认为急诊血管造影和干预可能困难或复杂;
- 计划进行选择性外科手术,这将需要在入组后的前六个月中断噻吩并吡啶类药物;
- 存在非心脏合并症且预期寿命<1年或可能导致不遵守协议;
- 正在积极参与另一项药物或器械研究但未完成主要终点随访期的患者;
- 以前参加过该试验;
- 在过去 30 天内接受过冠状动脉支架植入术的患者。
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:阶乘赋值
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:药理臂
通过显示与普通肝素加常规使用 GP IIb/IIIa 抑制剂相比,比伐卢定(使用 GP IIb/IIIa 抑制剂保留对于血管成形术并发症)导致:
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静脉推注 0.75 mg/kg 的比伐卢定,然后在后勤可行的情况下尽快输注 1.75 mg/kg/h(最好在急诊室)。
其他名称:
60 U/kg IV 肝素,尽快开始(最好在急诊室)。
其他名称:
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有源比较器:支架臂
通过证明与其他相同的裸金属 EXPRESS2™ 支架相比,TAXUS™ 支架具有以下优势,从而确定紫杉醇洗脱 TAXUS™ 支架的安全性和有效性:
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无涂层裸金属支架
其他名称:
缓释紫杉醇洗脱支架
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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药理学组 - 主要不良缺血性心脏事件和主要出血事件
大体时间:30天
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发生重大不良心血管事件(死亡、再梗塞、因缺血和中风而进行的靶血管血运重建)和大出血(判定为与冠状动脉旁路移植术无关的出血)的参与者人数。
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30天
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支架臂 - 缺血性靶病变血运重建
大体时间:1年
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缺血性靶病变血运重建的参与者人数
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1年
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支架臂 - 死亡、再梗死、中风或支架血栓形成
大体时间:1年
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死亡、再梗死、中风或支架内血栓形成的参与者人数
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1年
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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药理学组 - 主要不良心血管事件
大体时间:30天
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发生主要不良心血管事件(死亡、再梗死、因缺血而进行的靶血管血运重建和中风)的参与者人数
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30天
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药理学分支 - 非冠状动脉旁路移植相关的大出血
大体时间:30天
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大出血的参与者人数(出血裁定与冠状动脉旁路移植术无关)
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30天
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支架臂 - 段二元血管造影再狭窄
大体时间:13个月
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具有节段二元血管造影再狭窄(13 个月血管造影子集)的参与者人数。
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13个月
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药理学组 - 主要不良心血管事件
大体时间:3年
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发生主要不良心血管事件(死亡、再梗死、因缺血而进行的靶血管血运重建和中风)的参与者人数
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3年
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任:Roxana Mehran, MD、CardioVascular Research Foundation
- 首席研究员:Gregg W Stone, MD、CardioVascular Research Foundation
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Giacoppo D, Madhavan MV, Baber U, Warren J, Bansilal S, Witzenbichler B, Dangas GD, Kirtane AJ, Xu K, Kornowski R, Brener SJ, Genereux P, Stone GW, Mehran R. Impact of Contrast-Induced Acute Kidney Injury After Percutaneous Coronary Intervention on Short- and Long-Term Outcomes: Pooled Analysis From the HORIZONS-AMI and ACUITY Trials. Circ Cardiovasc Interv. 2015 Aug;8(8):e002475. doi: 10.1161/CIRCINTERVENTIONS.114.002475.
- Genereux P, Madhavan MV, Mintz GS, Maehara A, Palmerini T, Lasalle L, Xu K, McAndrew T, Kirtane A, Lansky AJ, Brener SJ, Mehran R, Stone GW. Ischemic outcomes after coronary intervention of calcified vessels in acute coronary syndromes. Pooled analysis from the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) and ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) TRIALS. J Am Coll Cardiol. 2014 May 13;63(18):1845-54. doi: 10.1016/j.jacc.2014.01.034. Epub 2014 Feb 19.
- Dangas GD, Claessen BE, Mehran R, Xu K, Fahy M, Parise H, Henriques JP, Ohman EM, White HD, Stone GW. Development and validation of a stent thrombosis risk score in patients with acute coronary syndromes. JACC Cardiovasc Interv. 2012 Nov;5(11):1097-105. doi: 10.1016/j.jcin.2012.07.012.
- Kosmidou I, McAndrew T, Redfors B, Embacher M, Dizon JM, Mehran R, Ben-Yehuda O, Mintz GS, Stone GW. Correlation of Admission Heart Rate With Angiographic and Clinical Outcomes in Patients With Right Coronary Artery ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention: HORIZONS-AMI (The Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) Trial. J Am Heart Assoc. 2017 Jul 19;6(7):e006181. doi: 10.1161/JAHA.117.006181.
- Tamez H, Pinto DS, Kirtane AJ, Litherland C, Yeh RW, Dangas GD, Mehran R, Deliargyris EN, Ortiz G, Gibson CM, Stone GW. Effect of Short Procedural Duration With Bivalirudin on Increased Risk of Acute Stent Thrombosis in Patients With STEMI: A Secondary Analysis of the HORIZONS-AMI Randomized Clinical Trial. JAMA Cardiol. 2017 Jun 1;2(6):673-677. doi: 10.1001/jamacardio.2016.5669.
- Ducrocq G, Steg PG, Van't Hof A, Zeymer U, Mehran R, Hamm CW, Bernstein D, Prats J, Deliargyris EN, Stone GW. Utility of post-procedural anticoagulation after primary PCI for STEMI: insights from a pooled analysis of the HORIZONS-AMI and EUROMAX trials. Eur Heart J Acute Cardiovasc Care. 2017 Oct;6(7):659-665. doi: 10.1177/2048872616650869. Epub 2016 Jun 10.
- Dangas GD, Schoos MM, Steg PG, Mehran R, Clemmensen P, van 't Hof A, Prats J, Bernstein D, Deliargyris EN, Stone GW. Early Stent Thrombosis and Mortality After Primary Percutaneous Coronary Intervention in ST-Segment-Elevation Myocardial Infarction: A Patient-Level Analysis of 2 Randomized Trials. Circ Cardiovasc Interv. 2016 May;9(5):e003272. doi: 10.1161/CIRCINTERVENTIONS.115.003272.
- Weisz G, Smilowitz NR, Kirtane AJ, Rinaldi MJ, Parvataneni R, Xu K, Stuckey TD, Maehara A, Witzenbichler B, Neumann FJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Brodie BR, Mazzaferri EL Jr, Mehran R, Stone GW. Proton Pump Inhibitors, Platelet Reactivity, and Cardiovascular Outcomes After Drug-Eluting Stents in Clopidogrel-Treated Patients: The ADAPT-DES Study. Circ Cardiovasc Interv. 2015 Oct;8(10):e001952. doi: 10.1161/CIRCINTERVENTIONS.114.001952.
- Nikolsky E, Mehran R, Dangas GD, Xu K, Parvataneni R, Witzenbichler B, Guagliumi G, Kornowski R, Genereux P, Brener SJ, Stone GW. Cerebrovascular events after a primary percutaneous coronary intervention strategy for acute ST-segment-elevation myocardial infarction: analysis from the HORIZONS-AMI Trial. Circ Cardiovasc Interv. 2015 Apr;8(4):e002283. doi: 10.1161/CIRCINTERVENTIONS.114.002283.
- Stone GW, Mehran R, Goldstein P, Witzenbichler B, Van't Hof A, Guagliumi G, Hamm CW, Genereux P, Clemmensen P, Pocock SJ, Gersh BJ, Bernstein D, Deliargyris EN, Steg PG. Bivalirudin versus heparin with or without glycoprotein IIb/IIIa inhibitors in patients with STEMI undergoing primary percutaneous coronary intervention: pooled patient-level analysis from the HORIZONS-AMI and EUROMAX trials. J Am Coll Cardiol. 2015 Jan 6;65(1):27-38. doi: 10.1016/j.jacc.2014.10.029.
- Sanborn TA, Tomey MI, Mehran R, Genereux P, Witzenbichler B, Brener SJ, Kirtane AJ, McAndrew TC, Kornowski R, Dudek D, Nikolsky E, Stone GW. Femoral vascular closure device use, bivalirudin anticoagulation, and bleeding after primary angioplasty for STEMI: results from the HORIZONS-AMI trial. Catheter Cardiovasc Interv. 2015 Feb 15;85(3):371-9. doi: 10.1002/ccd.25663. Epub 2014 Oct 28.
- Stone SG, Serrao GW, Mehran R, Tomey MI, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Mockel M, Brener SJ, Dangas G, Stone GW. Incidence, predictors, and implications of reinfarction after primary percutaneous coronary intervention in ST-segment-elevation myocardial infarction: the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction Trial. Circ Cardiovasc Interv. 2014 Aug;7(4):543-51. doi: 10.1161/CIRCINTERVENTIONS.114.001360. Epub 2014 Jun 17.
- Keeley EC, Mehran R, Brener SJ, Witzenbichler B, Guagliumi G, Dudek D, Kornowski R, Dressler O, Fahy M, Xu K, Grines CL, Stone GW. Impact of multiple complex plaques on short- and long-term clinical outcomes in patients presenting with ST-segment elevation myocardial infarction (from the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction [HORIZONS-AMI] Trial). Am J Cardiol. 2014 May 15;113(10):1621-7. doi: 10.1016/j.amjcard.2014.02.016. Epub 2014 Mar 1.
- Larsen AI, Tomey MI, Mehran R, Nilsen DW, Kirtane AJ, Witzenbichler B, Guagliumi G, Brener SJ, Genereux P, Kornowski R, Dudek D, Gersh BJ, Stone GW. Comparison of outcomes in patients with ST-segment elevation myocardial infarction discharged on versus not on statin therapy (from the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction Trial). Am J Cardiol. 2014 Apr 15;113(8):1273-9. doi: 10.1016/j.amjcard.2014.01.401. Epub 2014 Jan 31.
- Stone GW, Clayton T, Deliargyris EN, Prats J, Mehran R, Pocock SJ. Reduction in cardiac mortality with bivalirudin in patients with and without major bleeding: The HORIZONS-AMI trial (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction). J Am Coll Cardiol. 2014 Jan 7-14;63(1):15-20. doi: 10.1016/j.jacc.2013.09.027. Epub 2013 Oct 16.
- Brener SJ, Dizon JM, Mehran R, Guerchicoff A, Lansky AJ, Farkouh M, Brodie B, Guagliumi G, Witzenbichler B, Fahy M, Parise H, Stone GW. Complementary prognostic utility of myocardial blush grade and ST-segment resolution after primary percutaneous coronary intervention: analysis from the HORIZONS-AMI trial. Am Heart J. 2013 Oct;166(4):676-83. doi: 10.1016/j.ahj.2013.07.025. Epub 2013 Sep 13.
- Palmerini T, Brener SJ, Mehran R, Dangas G, Genereux P, Riva DD, Mariani A, Xu K, Stone GW. Leukocyte count is a modulating factor for the mortality benefit of bivalirudin in ST-segment-elevation acute myocardial infarction: the HORIZONS-AMI trial. Circ Cardiovasc Interv. 2013 Oct 1;6(5):518-26. doi: 10.1161/CIRCINTERVENTIONS.113.000592. Epub 2013 Oct 1.
- Farkouh ME, Reiffel J, Dressler O, Nikolsky E, Parise H, Cristea E, Baran DA, Dizon J, Merab JP, Lansky AJ, Mehran R, Stone GW. Relationship between ST-segment recovery and clinical outcomes after primary percutaneous coronary intervention: the HORIZONS-AMI ECG substudy report. Circ Cardiovasc Interv. 2013 Jun;6(3):216-23. doi: 10.1161/CIRCINTERVENTIONS.112.000142. Epub 2013 May 7.
- Rakowski T, Dudek D, Dziewierz A, Yu J, Witzenbichler B, Guagliumi G, Kornowski R, Hartmann F, Lansky AJ, Brener SJ, Mehran R, Stone GW. Impact of infarct-related artery patency before primary PCI on outcome in patients with ST-segment elevation myocardial infarction: the HORIZONS-AMI trial. EuroIntervention. 2013 Mar;8(11):1307-14. doi: 10.4244/EIJV8I11A199.
- Caixeta A, Lansky AJ, Mehran R, Brener SJ, Claessen B, Genereux P, Palmerini T, Witzenbichler B, Guagliumi G, Brodie BR, Dudek D, Fahy M, Dangas GD, Stone GW; Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial investigators. Predictors of suboptimal TIMI flow after primary angioplasty for acute myocardial infarction: results from the HORIZONS-AMI trial. EuroIntervention. 2013 Jun 22;9(2):220-7. doi: 10.4244/EIJV9I2A37.
- Tobbia P, Brodie BR, Witzenbichler B, Metzger C, Guagliumi G, Yu J, Kellett MA, Stuckey T, Fahy M, Mehran R, Stone GW. Adverse event rates following primary PCI for STEMI at US and non-US hospitals: three-year analysis from the HORIZONS-AMI trial. EuroIntervention. 2013 Feb 22;8(10):1134-42. doi: 10.4244/EIJV8I10A176.
- Dudek D, Mehran R, Dziewierz A, Witzenbichler B, Brodie BR, Kornowski R, Fahy M, Lansky AJ, Rakowski T, Legutko J, Bryniarski L, Stone GW. Impact of advanced age on the safety and effectiveness of paclitaxel-eluting stent implantation in patients with ST-segment elevation myocardial infarction undergoing primary angioplasty: The HORIZONS-AMI trial. Catheter Cardiovasc Interv. 2013 Nov 15;82(6):869-77. doi: 10.1002/ccd.24813. Epub 2013 Aug 1.
- Dangas GD, Claessen BE, Mehran R, Xu K, Stone GW. Stent thrombosis after primary angioplasty for STEMI in relation to non-adherence to dual antiplatelet therapy over time: results of the HORIZONS-AMI trial. EuroIntervention. 2013 Jan 22;8(9):1033-9. doi: 10.4244/EIJV8I9A159.
- Zhao Z, Witzenbichler B, Mintz GS, Jaster M, Choi SY, Wu X, He Y, Margolis MP, Dressler O, Cristea E, Parise H, Mehran R, Stone GW, Maehara A. Dynamic nature of nonculprit coronary artery lesion morphology in STEMI: a serial IVUS analysis from the HORIZONS-AMI trial. JACC Cardiovasc Imaging. 2013 Jan;6(1):86-95. doi: 10.1016/j.jcmg.2012.08.010.
- Jarai R, Dangas G, Huber K, Xu K, Brodie BR, Witzenbichler B, Metzger DC, Radke PW, Yu J, Claessen BE, Genereux P, Mehran R, Stone GW. B-type natriuretic peptide and risk of contrast-induced acute kidney injury in acute ST-segment-elevation myocardial infarction: a substudy from the HORIZONS-AMI trial. Circ Cardiovasc Interv. 2012 Dec;5(6):813-20. doi: 10.1161/CIRCINTERVENTIONS.112.972356. Epub 2012 Nov 27.
- Planer D, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Xu K, Fahy M, Mehran R, Stone GW. Impact of hyperglycemia in patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention: the HORIZONS-AMI trial. Int J Cardiol. 2013 Sep 10;167(6):2572-9. doi: 10.1016/j.ijcard.2012.06.054. Epub 2012 Jul 12.
- Dangas GD, Claessen BE, Mehran R, Brener S, Brodie BR, Dudek D, Witzenbichler B, Peruga JZ, Guagliumi G, Moses JW, Lansky AJ, Xu K, Stone GW. Clinical outcomes following stent thrombosis occurring in-hospital versus out-of-hospital: results from the HORIZONS-AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) trial. J Am Coll Cardiol. 2012 May 15;59(20):1752-9. doi: 10.1016/j.jacc.2011.12.042.
- Xu K, Mintz GS, Kubo T, Wu X, Guo N, Yang J, Witzenbichler B, Guagliumi G, Brodie B, Dressler O, Cristea E, Parise H, Mehran R, Stone GW, Maehara A. Long-term follow-up of attenuated plaques in patients with acute myocardial infarction: an intravascular ultrasound substudy of the HORIZONS-AMI trial. Circ Cardiovasc Interv. 2012 Apr;5(2):185-92. doi: 10.1161/CIRCINTERVENTIONS.111.964684. Epub 2012 Mar 20.
- Suh JW, Mehran R, Claessen BE, Xu K, Baber U, Dangas G, Parise H, Lansky AJ, Witzenbichler B, Grines CL, Guagliumi G, Kornowski R, Wohrle J, Dudek D, Weisz G, Stone GW. Impact of in-hospital major bleeding on late clinical outcomes after primary percutaneous coronary intervention in acute myocardial infarction the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) trial. J Am Coll Cardiol. 2011 Oct 18;58(17):1750-6. doi: 10.1016/j.jacc.2011.07.021.
- Kornowski R, Mehran R, Dangas G, Nikolsky E, Assali A, Claessen BE, Gersh BJ, Wong SC, Witzenbichler B, Guagliumi G, Dudek D, Fahy M, Lansky AJ, Stone GW; HORIZONS-AMI Trial Investigators. Prognostic impact of staged versus "one-time" multivessel percutaneous intervention in acute myocardial infarction: analysis from the HORIZONS-AMI (harmonizing outcomes with revascularization and stents in acute myocardial infarction) trial. J Am Coll Cardiol. 2011 Aug 9;58(7):704-11. doi: 10.1016/j.jacc.2011.02.071.
- Witzenbichler B, Mehran R, Guagliumi G, Dudek D, Huber K, Kornowski R, Stuckey TD, Fahy M, Parise H, Stone GW. Impact of diabetes mellitus on the safety and effectiveness of bivalirudin in patients with acute myocardial infarction undergoing primary angioplasty: analysis from the HORIZONS-AMI (Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction) trial. JACC Cardiovasc Interv. 2011 Jul;4(7):760-8. doi: 10.1016/j.jcin.2011.04.008.
- Stone GW, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Kornowski R, Hartmann F, Gersh BJ, Pocock SJ, Dangas G, Wong SC, Fahy M, Parise H, Mehran R; HORIZONS-AMI Trial Investigators. Heparin plus a glycoprotein IIb/IIIa inhibitor versus bivalirudin monotherapy and paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction (HORIZONS-AMI): final 3-year results from a multicentre, randomised controlled trial. Lancet. 2011 Jun 25;377(9784):2193-204. doi: 10.1016/S0140-6736(11)60764-2. Epub 2011 Jun 12.
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- Witzenbichler B, Wohrle J, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Kornowski R, Hartmann F, Hood KL, Parise H, Lansky AJ, Nikolsky E, Mehran R, Stone GW. Paclitaxel-eluting stents compared with bare metal stents in diabetic patients with acute myocardial infarction: the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial. Circ Cardiovasc Interv. 2011 Apr 1;4(2):130-8. doi: 10.1161/CIRCINTERVENTIONS.110.960245. Epub 2011 Mar 1.
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- Guagliumi G, Costa MA, Sirbu V, Musumeci G, Bezerra HG, Suzuki N, Matiashvili A, Lortkipanidze N, Mihalcsik L, Trivisonno A, Valsecchi O, Mintz GS, Dressler O, Parise H, Maehara A, Cristea E, Lansky AJ, Mehran R, Stone GW. Strut coverage and late malapposition with paclitaxel-eluting stents compared with bare metal stents in acute myocardial infarction: optical coherence tomography substudy of the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) Trial. Circulation. 2011 Jan 25;123(3):274-81. doi: 10.1161/CIRCULATIONAHA.110.963181. Epub 2011 Jan 10.
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2005年3月1日
初级完成 (实际的)
2008年6月1日
研究完成 (实际的)
2010年11月1日
研究注册日期
首次提交
2007年2月9日
首先提交符合 QC 标准的
2007年2月9日
首次发布 (估计)
2007年2月12日
研究记录更新
最后更新发布 (实际的)
2017年12月4日
上次提交的符合 QC 标准的更新
2017年11月30日
最后验证
2017年11月1日
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.