PCI時または非ST上昇心筋梗塞診断時のプラスグレルの比較 (ACCOAST)
2014年1月17日 更新者：Eli Lilly and Company
非ST上昇型心筋梗塞（NSTEMI）患者における経皮的冠動脈インターベンション（PCI）時または診断時の前治療としてのプラスグレルの比較：ACCOAST研究
この試験の目的は、冠動脈造影/経皮的冠動脈インターベンション（PCI）が予定されているトロポニン上昇を伴う非ST上昇型心筋梗塞（NSTEMI）参加者におけるプラスグレルによる前治療に関する潜在的な利益/リスクを調査することである。
調査の概要
詳細な説明
この試験は 2 つの部門で構成されています。 1 つのアームは非治療前アームです。 この群の参加者は、NSTEMI診断の直後、診断用冠動脈造影検査の前にプラセボを投与されます。 PCIに進む場合、冠状動脈造影の直後に60 mgのプラスグレル負荷用量が投与されます。 その後、参加者は30日目まで維持用量のプラスグレルを毎日投与されます。 75歳以上の参加者、または体重が60キログラム（kg）未満の参加者は、毎日5mgの経口投与を受ける。 他の全員には、毎日維持用量として 10 mg を 30 日間経口投与します。
もう一方のアームは前治療アームであり、参加者は NSTEMI 診断直後および診断用冠動脈造影前にプラスグレル 30 mg を投与する分割負荷投与レジメンを受けます。 負荷用量の残り（30 mg）は、参加者が PCI に進むときに投与されます。 その後、参加者は30日目まで維持用量のプラスグレルを毎日投与されます。 75歳以上の参加者、または体重が60kg未満の参加者には、毎日5mgの経口投与が行われます。 他の全員には、毎日維持用量として 10 mg を 30 日間経口投与します。
研究の種類
介入
入学 (実際)
4033
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Beer Yaakov、イスラエル、70300
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Haifa、イスラエル、34362
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Jerusalem、イスラエル、91120
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Kfar Saba、イスラエル、44281
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Nahariya、イスラエル、22100
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Tel-Aviv、イスラエル、64239
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Tiberias、イスラエル、15208
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Arezzo、イタリア、52100
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Chieti、イタリア、66013
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Grosseto、イタリア、58100
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Legnano、イタリア、20025
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Lucca、イタリア
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Massa、イタリア、54100
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Monza、イタリア、20900
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Napoli、イタリア、80100
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Pavia、イタリア、27100
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Perugia、イタリア、06156
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Pisa、イタリア、56100
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Prato、イタリア、50047
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Reggio Emilia、イタリア、42100
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Rome、イタリア、00100
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Torino、イタリア、10100
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Udine、イタリア、33100
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Venezia、イタリア、30035
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Amsterdam、オランダ、1081 HV
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Eindhoven、オランダ、5623 EJ
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Leeuwarden、オランダ、8934 AD
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Nieuwegein、オランダ、3435 CM
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Nijmegen、オランダ、6500 HB
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Tiel、オランダ、4002 WP
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Zwolle、オランダ、8025 AB
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Braunau Am Inn、オーストリア、5280
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Graz、オーストリア、8020
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Linz、オーストリア、4020
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Vienna、オーストリア、A1090
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Alberta
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Calgary、Alberta、カナダ、T2N 2T9
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British Columbia
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Vancouver、British Columbia、カナダ、Vancouver
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Ontario
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Toronto、Ontario、カナダ、M5B 1W8
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Quebec
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Montreal、Quebec、カナダ、H4J 1C5
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Sainte-Foy、Quebec、カナダ、G1V 4G5
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Saskatchewan
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Saskatoon、Saskatchewan、カナダ、S7N 0W8
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Goteborg、スウェーデン、413 45
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Banska Bystrica、スロバキア、97401
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Kosice、スロバキア、04011
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Nitra、スロバキア、94901
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Brno、チェコ共和国、625 00
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Hradec Kralove、チェコ共和国、500 05
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Olomouc、チェコ共和国、775 20
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Plzen、チェコ共和国、30460
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Prague、チェコ共和国、169 02
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Usti Nad Labem、チェコ共和国、40113
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Bad Nauheim、ドイツ、61231
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Bad Segeberg、ドイツ、23795
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Bochum、ドイツ、44791
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Bonn、ドイツ、53105
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Coburg、ドイツ、96450
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Dachau、ドイツ、85221
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Eutin、ドイツ、23701
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Frankfurt、ドイツ、60596
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Halle、ドイツ、06120
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Hamburg、ドイツ、20099
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Hannover、ドイツ、30625
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Heidelberg、ドイツ、D-69120
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Jena、ドイツ、07740
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Kassel、ドイツ、34125
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Leipzig、ドイツ、04289
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Ludwigshafen、ドイツ、67063
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Mainz、ドイツ、55101
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Munich、ドイツ、80336
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Rastatt、ドイツ、76437
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Rostock、ドイツ、18057
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Villingen-Schwenningen、ドイツ、78050
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Balatonfured、ハンガリー、8230
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Budapest、ハンガリー、1096
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Pecs、ハンガリー、7624
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Zalaegerszeg、ハンガリー、8900
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Turku、フィンランド、20521
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Bastia、フランス、20600
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Bron、フランス、69500
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Caluire Et Cuire、フランス、69300
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Cannes Cedex、フランス、06401
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Chateauroux、フランス、36019
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Corbeil Essonnes、フランス、91106
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lagny Sur Marne、フランス、77405
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Le Coudray、フランス、28630
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lille、フランス、59037
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lyon、フランス、69317
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Marseille、フランス、13015
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Metz、フランス、57085
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Metz Tessy、フランス、74370
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Montauban、フランス、82017
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Montreuil、フランス、93105
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nimes、フランス、30029
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Paris、フランス、75743
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Pau Cedex、フランス、64046
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pierre Benite、フランス、69495
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Rennes、フランス、35033
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Toulouse、フランス、31076
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Valence、フランス、26953
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Vannes、フランス、56017
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Vienne、フランス、38209
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Villeurbanne、フランス、69100
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bonheiden、ベルギー、2820
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Brugge、ベルギー、8000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Charleroi、ベルギー、6000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Genk、ベルギー、3600
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Leuven、ベルギー、3000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Yvoir、ベルギー、5530
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Braga、ポルトガル、4710-243
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Carnaxide、ポルトガル、2794-006
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Faro、ポルトガル、8000-386
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Leiria、ポルトガル、2410-197
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Belchatow、ポーランド、97-400
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Chrzanow、ポーランド、32-500
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Grodzisk Mazowiecki、ポーランド、05-825
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Katowice、ポーランド、40-635
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Klodzko、ポーランド、57-300
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Krakow、ポーランド、31-501
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lodz、ポーランド、91-347
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lublin、ポーランド、20-954
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Mielec、ポーランド、39-300
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Naleczow、ポーランド、24-140
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nowy Sacz、ポーランド、33-300
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nowy Targ、ポーランド、34-400
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nysa、ポーランド、48-300
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ostrowiec Swietokrzyski、ポーランド、27-400
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Oswiecim、ポーランド、32-600
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Polanica-Zdroj、ポーランド、57-320
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pulawy、ポーランド、24-100
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Radom、ポーランド、26-617
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Sanok、ポーランド、38-500
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Stalowa Wola、ポーランド、37-450
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Starogard Gdanski、ポーランド、82-200
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tarnow、ポーランド、33-100
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Warsaw、ポーランド、04-628
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wejherowo、ポーランド、84-200
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wroclaw、ポーランド、53-114
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Liepaja、ラトビア、3414
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Riga、ラトビア、1038
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kaunas、リトアニア、LT-50009
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Klaipedos、リトアニア、92288
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Vilnius、リトアニア、LT-08661
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bucharest、ルーマニア、050098
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Targu Mures、ルーマニア、540136
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Adana、七面鳥、1330
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ankara、七面鳥、06520
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Antalya、七面鳥、07070
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Fatih、七面鳥、34300
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Isparta、七面鳥、32100
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Istanbul、七面鳥、34303
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kayseri、七面鳥、38039
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kocaeli、七面鳥、41900
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Sisli、七面鳥、34381
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
包含基準:
- トロポニンの上昇を伴う非STセグメントの上昇からなる急性冠症候群がある
- 計画された無作為化の時間から 2 時間以上 24 時間未満、ただし無作為化から 48 時間以内に冠動脈造影/PCI が予定されている
- それぞれのラベルに従って、プラスグレル、アスピリン (ASA)、および糖タンパク質 IIb/IIIa 受容体 (GPIIb/IIIa) 阻害剤による治療の資格がある必要があります。
- 維持用量のクロピドグレル 75 mg を服用している可能性があり、プラスグレルに切り替えることができる必要がある
- 心臓カテーテル検査病院、または心臓カテーテル検査病院と提携する病院/救急車サービスに登録している必要があります。
除外基準:
- -登録時またはランダム化時にST上昇型心筋梗塞（STEMI）を患っている
- 心原性ショックを起こしている
- 難治性の心室不整脈がある
- ニューヨーク心臓協会 (NYHA) のクラス IV うっ血性心不全 (CHF) を患っている
- -研究への参加または無作為化から1週間以内に心停止を起こした
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：前処理なし
診断時にプラセボの経口負荷量が投与され、PCI時にプラスグレルの60ミリグラム（mg）経口負荷量が与えられ、その後プラスグレルの毎日の維持用量として5mgまたは10mgが30日間経口投与されます。
|
経口投与
他の名前：
1回経口投与
|
|
実験的：分割負荷量
診断時にプラスグレルの経口負荷用量30 mgが投与され、PCI時にプラスグレルの経口用量30 mgが投与され、その後プラスグレルの毎日の維持用量として5 mgまたは10 mgが30日間経口投与されます。
|
経口投与
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
心血管死（CV）、心筋梗塞（MI）、脳卒中、緊急血行再建術（UR）、または糖タンパク質（GP）IIb/IIIa阻害剤救済策を発症した参加者の割合
時間枠：最初の負荷用量 (LD) から最初の LD 後 7 日間まで
|
参加者の割合は、CV死亡、MI、脳卒中、URまたはGPIIb/IIIa阻害剤による救済を受けた参加者の総数を治療群の参加者の数で割った値に100を乗じたものです。
エンドポイントイベントは臨床エンドポイント委員会によって裁定されました。
|
最初の負荷用量 (LD) から最初の LD 後 7 日間まで
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
全死因死亡、心筋梗塞（MI）、脳卒中、または全冠動脈バイパス移植（CABG）および心筋梗塞における非CABG血栓溶解療法（TIMI）の大出血を起こした参加者の割合
時間枠：最初の負荷用量 (LD) から最初の LD 後 7 日間まで
|
参加者の割合は、全死因死亡、心筋梗塞、脳卒中、またはCABGおよび非CABG TIMI大出血を経験した参加者の総数を治療群の参加者の数で割った値に100を乗じたものです。
エンドポイントイベントは臨床エンドポイント委員会によって裁定されました。
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最初の負荷用量 (LD) から最初の LD 後 7 日間まで
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最初の負荷用量（LD）から30日以内に心血管死（CV）、心筋梗塞（MI）、または脳卒中が発生した参加者の割合
時間枠：最初の LD から最初の LD から 30 日後まで
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参加者の割合は、CV死亡、MI、または脳卒中を経験した参加者の総数を治療群の参加者の数で割った値に100を掛けたものです。
エンドポイントイベントは臨床エンドポイント委員会によって裁定されました。
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最初の LD から最初の LD から 30 日後まで
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初回負荷量（LD）から30日間に心血管死（CV）または心筋梗塞（MI）が発生した参加者の割合
時間枠：最初の LD から最初の LD から 30 日後まで
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参加者のパーセンテージは、心血管死亡または心筋梗塞を経験した参加者の総数を治療群の参加者の数で割った値に 100 を乗じたものです。
エンドポイントイベントは臨床エンドポイント委員会によって裁定されました。
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最初の LD から最初の LD から 30 日後まで
|
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初回負荷量（LD）から30日以内に心血管死（CV）、心筋梗塞（MI）、または緊急血行再建術（UR）が発生した参加者の割合
時間枠：最初の LD から最初の LD から 30 日後まで
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参加者のパーセンテージは、CV 死亡、MI、または UR を経験した参加者の総数を治療群の参加者数で割った値に 100 を乗じたものです。
エンドポイントイベントは臨床エンドポイント委員会によって裁定されました。
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最初の LD から最初の LD から 30 日後まで
|
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初回負荷量（LD）から30日間に心血管疾患（CV）死亡が発生した参加者の割合
時間枠：最初の LD から最初の LD から 30 日後まで
|
参加者の割合は、CV死亡を経験した参加者の総数を治療群の参加者の数で割った値に100を掛けたものです。
エンドポイントイベントは臨床エンドポイント委員会によって裁定されました。
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最初の LD から最初の LD から 30 日後まで
|
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学術研究コンソーシアム (ARC) の基準に基づく、最初の投与量 (LD) から 30 日間に確定的または可能性のあるステント血栓症 (ST) が発生した参加者の割合
時間枠：最初の LD から最初の LD から 30 日後まで
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STの定義にはARC基準が使用されました。
明確な ST は、ステント周囲領域内の部分的または完全な血栓性閉塞の血管造影または病理学的確認であり、次の追加基準の少なくとも 1 つを満たします。急性虚血症状。虚血性心電図の変化。心臓バイオマーカーの上昇。
ST の可能性とは、ステント移植後 30 日以内の原因不明の死亡です。血管造影による ST の確認がなく、その他の明らかな原因がない場合に、移植されたステントの領域で記録された急性虚血に関連する MI 。
参加者のパーセンテージは、明らかなステント血栓症またはその可能性の高いステント血栓症を経験している参加者の総数を治療群の参加者の数で割った値に 100 を乗じたものです。
エンドポイントイベントは臨床エンドポイント委員会によって裁定されました。
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最初の LD から最初の LD から 30 日後まで
|
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全死因死亡、心筋梗塞（MI）、脳卒中、または全冠動脈バイパス移植（CABG）および心筋梗塞における非CABG血栓溶解療法（TIMI）があり、初回負荷量（LD）から30日間にわたる大出血を起こした参加者の割合
時間枠：最初の LD から最初の LD から 30 日後まで
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参加者の割合は、全死因死亡、心筋梗塞、脳卒中、またはCABGおよび非CABG TIMI大出血を経験した参加者の総数を治療群の参加者の数で割った値に100を乗じたものです。
エンドポイントイベントは臨床エンドポイント委員会によって裁定されました。
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最初の LD から最初の LD から 30 日後まで
|
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ベースラインから経皮的冠動脈インターベンション（PCI）までの標準化トロポニンの変化
時間枠：ベースライン、PCI 前（ランダム化後 48 時間以内）
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標準化されたトロポニンは、分析されたトロポニン値を正常値の上限 (ULN) で割った比として定義されます。
最小二乗法 (LS) 平均は、治療を固定効果として、ベースライン標準化トロポニンを共変量として使用した共分散分析 (ANCOVA) モデルから得られました。
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ベースライン、PCI 前（ランダム化後 48 時間以内）
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心筋梗塞（TIMI）大出血におけるすべての冠状動脈バイパス移植（CABG）または非CABG血栓溶解療法が発生した参加者の割合
時間枠：最初の負荷用量 (LD) から最初の LD 後 7 日間まで
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参加者の割合は、CABG または非 CABG TIMI 大出血を経験した参加者の総数を治療群の参加者の数で割った値に 100 を乗じたものです。
エンドポイントイベントは臨床エンドポイント委員会によって裁定されました。
|
最初の負荷用量 (LD) から最初の LD 後 7 日間まで
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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全死因死亡の概要
時間枠：30日間にわたるランダム化
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関連性の可能性に関係なく、すべての死亡は臨床エンドポイント委員会 (CEC) によって裁定され、この表に報告されています。
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30日間にわたるランダム化
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2009年12月1日
一次修了 (実際)
2013年1月1日
研究の完了 (実際)
2013年2月1日
試験登録日
最初に提出
2009年11月17日
QC基準を満たした最初の提出物
2009年11月17日
最初の投稿 (見積もり)
2009年11月18日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年2月28日
QC基準を満たした最後の更新が送信されました
2014年1月17日
最終確認日
2014年1月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。