普拉格雷在 PCI 或非 ST 段抬高心肌梗死诊断时间的比较 (ACCOAST)
2014年1月17日 更新者：Eli Lilly and Company
普拉格雷在非 ST 段抬高心肌梗死 (NSTEMI) 患者经皮冠状动脉介入治疗 (PCI) 时或在诊断时作为预处理的比较：ACCOAST 研究
本试验的目的是调查在肌钙蛋白升高的非 ST 段抬高心肌梗死 (NSTEMI) 参与者中使用普拉格雷预处理的潜在益处/风险，计划进行冠状动脉造影/经皮冠状动脉介入治疗 (PCI)。
研究概览
详细说明
该试验由两个臂组成。 一只手臂是非预处理手臂。 该组的参与者将在 NSTEMI 诊断后和诊断性冠状动脉造影之前立即接受安慰剂。 进行 PCI 时，冠状动脉造影后将立即给予 60 mg 普拉格雷负荷剂量。 随后，参与者将接受每日维持剂量的普拉格雷直至第 30 天。 大于或等于 75 岁或体重小于 60 公斤 (kg) 的参与者每天将接受 5 毫克口服剂量。 所有其他人将接受 10 毫克的每日口服维持剂量，持续 30 天。
另一组是预处理组，参与者将在 NSTEMI 诊断后和诊断性冠状动脉造影前立即接受分负荷剂量方案，即 30 毫克普拉格雷。 当参与者进行 PCI 时，将给予剩余的负荷剂量 (30 mg)。 随后，参与者将接受每日维持剂量的普拉格雷直至第 30 天。 大于或等于 75 岁或体重小于 60 公斤的参与者每天将接受 5 毫克口服剂量。 所有其他人将接受 10 毫克的每日口服维持剂量，持续 30 天。
研究类型
介入性
注册 (实际的)
4033
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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Beer Yaakov、以色列、70300
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Haifa、以色列、34362
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Jerusalem、以色列、91120
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Kfar Saba、以色列、44281
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Nahariya、以色列、22100
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Tel-Aviv、以色列、64239
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Tiberias、以色列、15208
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Alberta
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Calgary、Alberta、加拿大、T2N 2T9
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British Columbia
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Vancouver、British Columbia、加拿大、Vancouver
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Ontario
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Toronto、Ontario、加拿大、M5B 1W8
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Quebec
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Montreal、Quebec、加拿大、H4J 1C5
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Sainte-Foy、Quebec、加拿大、G1V 4G5
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Saskatchewan
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Saskatoon、Saskatchewan、加拿大、S7N 0W8
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Balatonfured、匈牙利、8230
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Budapest、匈牙利、1096
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Pecs、匈牙利、7624
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Zalaegerszeg、匈牙利、8900
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Braunau Am Inn、奥地利、5280
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Graz、奥地利、8020
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Linz、奥地利、4020
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Vienna、奥地利、A1090
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Bad Nauheim、德国、61231
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Bad Segeberg、德国、23795
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Bochum、德国、44791
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Bonn、德国、53105
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Coburg、德国、96450
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Dachau、德国、85221
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Eutin、德国、23701
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Frankfurt、德国、60596
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Halle、德国、06120
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Hamburg、德国、20099
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Hannover、德国、30625
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Heidelberg、德国、D-69120
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Jena、德国、07740
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Kassel、德国、34125
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Leipzig、德国、04289
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Ludwigshafen、德国、67063
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Mainz、德国、55101
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Munich、德国、80336
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Rastatt、德国、76437
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Rostock、德国、18057
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Villingen-Schwenningen、德国、78050
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Arezzo、意大利、52100
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Chieti、意大利、66013
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Grosseto、意大利、58100
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Legnano、意大利、20025
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Lucca、意大利
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Massa、意大利、54100
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Monza、意大利、20900
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Napoli、意大利、80100
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Pavia、意大利、27100
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Perugia、意大利、06156
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Pisa、意大利、56100
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Prato、意大利、50047
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Reggio Emilia、意大利、42100
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Rome、意大利、00100
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Torino、意大利、10100
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Udine、意大利、33100
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Venezia、意大利、30035
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Liepaja、拉脱维亚、3414
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Riga、拉脱维亚、1038
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Brno、捷克共和国、625 00
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Hradec Kralove、捷克共和国、500 05
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Olomouc、捷克共和国、775 20
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Plzen、捷克共和国、30460
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Prague、捷克共和国、169 02
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Usti Nad Labem、捷克共和国、40113
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Banska Bystrica、斯洛伐克、97401
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Kosice、斯洛伐克、04011
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Nitra、斯洛伐克、94901
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Bonheiden、比利时、2820
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Brugge、比利时、8000
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Charleroi、比利时、6000
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Genk、比利时、3600
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Leuven、比利时、3000
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Yvoir、比利时、5530
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Bastia、法国、20600
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Bron、法国、69500
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Caluire Et Cuire、法国、69300
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Cannes Cedex、法国、06401
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Chateauroux、法国、36019
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Corbeil Essonnes、法国、91106
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Lagny Sur Marne、法国、77405
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Le Coudray、法国、28630
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Lille、法国、59037
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Lyon、法国、69317
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Marseille、法国、13015
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Metz、法国、57085
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Metz Tessy、法国、74370
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Montauban、法国、82017
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Montreuil、法国、93105
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Nimes、法国、30029
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Paris、法国、75743
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Pau Cedex、法国、64046
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Pierre Benite、法国、69495
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Rennes、法国、35033
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Toulouse、法国、31076
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Valence、法国、26953
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Vannes、法国、56017
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Vienne、法国、38209
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Villeurbanne、法国、69100
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Belchatow、波兰、97-400
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Chrzanow、波兰、32-500
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Grodzisk Mazowiecki、波兰、05-825
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Katowice、波兰、40-635
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Klodzko、波兰、57-300
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Krakow、波兰、31-501
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Lodz、波兰、91-347
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Lublin、波兰、20-954
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Mielec、波兰、39-300
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Naleczow、波兰、24-140
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Nowy Sacz、波兰、33-300
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Nowy Targ、波兰、34-400
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Nysa、波兰、48-300
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Ostrowiec Swietokrzyski、波兰、27-400
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Oswiecim、波兰、32-600
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Polanica-Zdroj、波兰、57-320
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Pulawy、波兰、24-100
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Radom、波兰、26-617
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Sanok、波兰、38-500
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Stalowa Wola、波兰、37-450
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Starogard Gdanski、波兰、82-200
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Tarnow、波兰、33-100
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Warsaw、波兰、04-628
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Wejherowo、波兰、84-200
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Wroclaw、波兰、53-114
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Adana、火鸡、1330
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Ankara、火鸡、06520
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Antalya、火鸡、07070
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Fatih、火鸡、34300
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Isparta、火鸡、32100
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Istanbul、火鸡、34303
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Kayseri、火鸡、38039
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Kocaeli、火鸡、41900
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Sisli、火鸡、34381
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Goteborg、瑞典、413 45
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Kaunas、立陶宛、LT-50009
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Klaipedos、立陶宛、92288
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Vilnius、立陶宛、LT-08661
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Bucharest、罗马尼亚、050098
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Targu Mures、罗马尼亚、540136
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Turku、芬兰、20521
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Amsterdam、荷兰、1081 HV
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Eindhoven、荷兰、5623 EJ
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Leeuwarden、荷兰、8934 AD
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Nieuwegein、荷兰、3435 CM
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Nijmegen、荷兰、6500 HB
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Tiel、荷兰、4002 WP
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Zwolle、荷兰、8025 AB
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Braga、葡萄牙、4710-243
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Carnaxide、葡萄牙、2794-006
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Faro、葡萄牙、8000-386
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Leiria、葡萄牙、2410-197
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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：
- 患有急性冠状动脉综合征，包括非 ST 段抬高伴肌钙蛋白升高
- 计划进行冠状动脉造影/PCI 的时间大于或等于 2 小时且小于计划随机化时间的 24 小时，但不超过随机化时间的 48 小时
- 必须有资格按照各自的标签接受普拉格雷、阿司匹林 (ASA) 和糖蛋白 IIb/IIIa 受体 (GPIIb/IIIa) 抑制剂的治疗
- 可能服用维持剂量的氯吡格雷 75 毫克，并且必须能够换用普拉格雷
- 必须在心导管实验室医院或附属于心导管实验室医院的医院/救护车服务处注册
排除标准：
- 在进入或随机分组时存在 ST 段抬高型心肌梗死 (STEMI)
- 有心源性休克
- 有难治性室性心律失常
- 患有纽约心脏协会 (NYHA) IV 级充血性心力衰竭 (CHF)
- 在进入或随机化进入研究后 1 周内发生过心脏骤停
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：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：非预处理
在诊断时给予安慰剂口服负荷剂量，在 PCI 时给予 60 毫克 (mg) 普拉格雷口服负荷剂量，然后每天口服 5 毫克或 10 毫克维持剂量的普拉格雷，持续 30 天。
|
口服给药
其他名称：
口服给药一次
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实验性的：分装剂量
诊断时给予 30 mg 普拉格雷口服负荷剂量，PCI 时给予 30 mg 普拉格雷口服剂量，然后每天口服 5 mg 或 10 mg 普拉格雷维持剂量，持续 30 天
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口服给药
其他名称：
|
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 |
|---|---|---|
|
发生心血管 (CV) 死亡、心肌梗塞 (MI)、中风、紧急血运重建 (UR) 或糖蛋白 (GP) IIb/IIIa 抑制剂紧急救助的参与者百分比
大体时间：首次负荷剂量 (LD) 至首次 LD 后 7 天
|
参与者的百分比是经历 CV 死亡、MI、中风、UR 或 GPIIb/IIIa 抑制剂救助的参与者总数除以治疗组中的参与者人数再乘以 100。
终点事件由临床终点委员会裁定。
|
首次负荷剂量 (LD) 至首次 LD 后 7 天
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
全因死亡、心肌梗死 (MI)、中风或所有冠状动脉旁路移植术 (CABG) 和非 CABG 心肌梗死 (TIMI) 大出血溶栓患者的百分比
大体时间：首次负荷剂量 (LD) 至首次 LD 后 7 天
|
参与者的百分比是经历全因死亡、MI、中风或 CABG 和非 CABG TIMI 大出血的参与者总数除以治疗组的参与者人数乘以 100。
终点事件由临床终点委员会裁定。
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首次负荷剂量 (LD) 至首次 LD 后 7 天
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从首次负荷剂量 (LD) 起 30 天内发生心血管 (CV) 死亡、心肌梗塞 (MI) 或中风的参与者百分比
大体时间：第一个 LD 到第一个 LD 之后的 30 天
|
参与者的百分比是经历 CV 死亡、MI 或中风的参与者总数除以治疗组中的参与者人数再乘以 100。
终点事件由临床终点委员会裁定。
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第一个 LD 到第一个 LD 之后的 30 天
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首次负荷剂量 (LD) 后 30 天内发生心血管 (CV) 死亡或心肌梗死 (MI) 的参与者百分比
大体时间：第一个 LD 到第一个 LD 之后的 30 天
|
参与者的百分比是经历 CV 死亡或 MI 的参与者总数除以治疗组中的参与者人数再乘以 100。
终点事件由临床终点委员会裁定。
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第一个 LD 到第一个 LD 之后的 30 天
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首次负荷剂量 (LD) 后 30 天内发生心血管 (CV) 死亡、心肌梗死 (MI) 或紧急血运重建 (UR) 的参与者百分比
大体时间：第一个 LD 到第一个 LD 之后的 30 天
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参与者的百分比是经历 CV 死亡、MI 或 UR 的参与者总数除以治疗组中的参与者人数再乘以 100。
终点事件由临床终点委员会裁定。
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第一个 LD 到第一个 LD 之后的 30 天
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首次负荷剂量 (LD) 后 30 天内发生心血管 (CV) 死亡的参与者百分比
大体时间：第一个 LD 到第一个 LD 之后的 30 天
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参与者的百分比是经历 CV 死亡的参与者总数除以治疗组中的参与者人数再乘以 100。
终点事件由临床终点委员会裁定。
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第一个 LD 到第一个 LD 之后的 30 天
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根据学术研究联合会 (ARC) 标准，首次加载剂量 (LD) 后 30 天内确定或可能发生支架内血栓形成 (ST) 的参与者百分比
大体时间：第一个 LD 到第一个 LD 之后的 30 天
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ARC 标准用于定义 ST。
明确 ST 是支架周围区域部分或全部血栓性闭塞的血管造影或病理证实，并且至少有以下附加标准之一：急性缺血症状；缺血性心电图改变；升高的心脏生物标志物。
可能 ST 是支架植入后 30 天内任何无法解释的死亡；任何 MI，它与植入支架区域内记录的急性缺血有关，没有 ST 的血管造影确认，并且没有任何其他明显的原因。
参与者的百分比是经历明确或可能的支架血栓形成的参与者总数除以治疗组中的参与者人数再乘以 100。
终点事件由临床终点委员会裁定。
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第一个 LD 到第一个 LD 之后的 30 天
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首次负荷剂量 (LD) 后 30 天内发生全因死亡、心肌梗死 (MI)、中风或所有冠状动脉旁路移植术 (CABG) 和非 CABG 溶栓治疗心肌梗死 (TIMI) 大出血的参与者百分比
大体时间：第一个 LD 到第一个 LD 之后的 30 天
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参与者的百分比是经历全因死亡、MI、中风或 CABG 和非 CABG TIMI 大出血的参与者总数除以治疗组的参与者人数乘以 100。
终点事件由临床终点委员会裁定。
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第一个 LD 到第一个 LD 之后的 30 天
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标准化肌钙蛋白从基线到经皮冠状动脉介入治疗 (PCI) 的变化
大体时间：基线，PCI 前（随机分组后不超过 48 小时）
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标准化肌钙蛋白定义为测定的肌钙蛋白值除以正常上限 (ULN) 的比率。
最小二乘法 (LS) 平均值是从协方差分析 (ANCOVA) 模型中获得的，其中治疗作为固定效应，基线标准化肌钙蛋白作为协变量。
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基线，PCI 前（随机分组后不超过 48 小时）
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所有冠状动脉旁路移植术 (CABG) 或非 CABG 溶栓治疗心肌梗死 (TIMI) 大出血的参与者百分比
大体时间：首次负荷剂量 (LD) 至首次 LD 后 7 天
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参与者的百分比是经历 CABG 或非 CABG TIMI 大出血的参与者总数除以治疗组的参与者人数再乘以 100。
终点事件由临床终点委员会裁定。
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首次负荷剂量 (LD) 至首次 LD 后 7 天
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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全因死亡总结
大体时间：通过 30 天随机化
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所有死亡，无论可能的相关性如何，均由临床终点委员会 (CEC) 裁定并报告在此表中。
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通过 30 天随机化
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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。
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
- Silvain J, Rakowski T, Lattuca B, Liu Z, Bolognese L, Goldstein P, Hamm C, Tanguay JF, Ten Berg J, Widimsky P, Miller D, Portal JJ, Collet JP, Vicaut E, Montalescot G, Dudek D; ACCOAST Investigators. Interval From Initiation of Prasugrel to Coronary Angiography in Patients With Non-ST-Segment Elevation Myocardial Infarction. J Am Coll Cardiol. 2019 Mar 5;73(8):906-914. doi: 10.1016/j.jacc.2018.11.055.
- Porto I, Bolognese L, Dudek D, Goldstein P, Hamm C, Tanguay JF, Ten Berg J, Widimsky P, Le Gall N, Zagar AJ, LeNarz LA, Miller D, Montalescot G; ACCOAST Investigators. Impact of Access Site on Bleeding and Ischemic Events in Patients With Non-ST-Segment Elevation Myocardial Infarction Treated With Prasugrel: The ACCOAST Access Substudy. JACC Cardiovasc Interv. 2016 May 9;9(9):897-907. doi: 10.1016/j.jcin.2016.01.041.
- Dudek D, Dziewierz A, Widimsky P, Bolognese L, Goldstein P, Hamm C, Tanguay JF, LeNarz L, Miller DL, Brown E, Ten Berg J, Montalescot G; ACCOAST Investigators. Impact of prasugrel pretreatment and timing of coronary artery bypass grafting on clinical outcomes of patients with non-ST-segment elevation myocardial infarction: From the A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST-Elevation Myocardial Infarction (ACCOAST) study. Am Heart J. 2015 Nov;170(5):1025-1032.e2. doi: 10.1016/j.ahj.2015.07.017. Epub 2015 Jul 26.
- Widimsky P, Motovska Z, Bolognese L, Dudek D, Hamm C, Tanguay JF, Ten Berg J, Brown E, LeNarz L, Miller DL, Montalescot G; ACCOAST Investigators. Predictors of bleeding in patients with acute coronary syndromes treated with prasugrel. Heart. 2015 Aug;101(15):1219-24. doi: 10.1136/heartjnl-2015-307686. Epub 2015 Jun 9.
- Montalescot G, Collet JP, Ecollan P, Bolognese L, Ten Berg J, Dudek D, Hamm C, Widimsky P, Tanguay JF, Goldstein P, Brown E, Miller DL, LeNarz L, Vicaut E; ACCOAST Investigators. Effect of prasugrel pre-treatment strategy in patients undergoing percutaneous coronary intervention for NSTEMI: the ACCOAST-PCI study. J Am Coll Cardiol. 2014 Dec 23;64(24):2563-2571. doi: 10.1016/j.jacc.2014.08.053.
- Montalescot G, Bolognese L, Dudek D, Goldstein P, Hamm C, Tanguay JF, ten Berg JM, Miller DL, Costigan TM, Goedicke J, Silvain J, Angioli P, Legutko J, Niethammer M, Motovska Z, Jakubowski JA, Cayla G, Visconti LO, Vicaut E, Widimsky P; ACCOAST Investigators. Pretreatment with prasugrel in non-ST-segment elevation acute coronary syndromes. N Engl J Med. 2013 Sep 12;369(11):999-1010. doi: 10.1056/NEJMoa1308075. Epub 2013 Sep 1.
- Montalescot G, Bolognese L, Dudek D, Goldstein P, Hamm C, Tanguay JF, ten Berg J, Widimsky P, Luo J, Miller DL, Goedicke J. A comparison of prasugrel at the time of percutaneous coronary intervention or as pretreatment at the time of diagnosis in patients with non-ST-segment elevation myocardial infarction: design and rationale for the ACCOAST study. Am Heart J. 2011 Apr;161(4):650-656.e1. doi: 10.1016/j.ahj.2010.10.017. Epub 2011 Feb 25.
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
2009年12月1日
初级完成 (实际的)
2013年1月1日
研究完成 (实际的)
2013年2月1日
研究注册日期
首次提交
2009年11月17日
首先提交符合 QC 标准的
2009年11月17日
首次发布 (估计)
2009年11月18日
研究记录更新
最后更新发布 (估计)
2014年2月28日
上次提交的符合 QC 标准的更新
2014年1月17日
最后验证
2014年1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.