Een vergelijking van prasugrel op PCI of tijdstip van diagnose van myocardinfarct zonder ST-elevatie (ACCOAST)
17 januari 2014 bijgewerkt door: Eli Lilly and Company
Een vergelijking van prasugrel op het moment van percutane coronaire interventie (PCI) of als voorbehandeling op het moment van diagnose bij patiënten met niet-ST-elevatie myocardinfarct (NSTEMI): de ACCOAST-studie
Het doel van deze studie is om de mogelijke voordelen/risico's te onderzoeken met betrekking tot voorbehandeling met prasugrel bij niet-ST-elevatie myocardinfarct (NSTEMI) deelnemers met verhoogd troponine gepland voor coronaire angiografie/percutane coronaire interventie (PCI).
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Deze proef bestaat uit twee armen. Eén arm is een arm zonder voorbehandeling. Deelnemers aan deze arm krijgen een placebo onmiddellijk na de NSTEMI-diagnose en voorafgaand aan de diagnostische coronaire angiografie. Een oplaaddosis van 60 mg prasugrel zal onmiddellijk na coronaire angiografie worden gegeven wanneer overgegaan wordt tot PCI. Vervolgens krijgen de deelnemers dagelijkse onderhoudsdoses prasugrel tot dag 30. Deelnemers die ouder zijn dan of gelijk zijn aan 75 jaar of die een lichaamsgewicht van minder dan 60 kilogram (kg) hebben, krijgen dagelijks een orale dosis van 5 mg. Alle anderen krijgen gedurende 30 dagen een orale dagelijkse onderhoudsdosis van 10 mg.
De andere arm is een voorbehandelingsarm waar deelnemers een gesplitst oplaaddosisregime krijgen met 30 mg prasugrel, toegediend onmiddellijk na NSTEMI-diagnose en voorafgaand aan diagnostische coronaire angiografie. De rest van de oplaaddosis (30 mg) wordt toegediend wanneer de deelnemers naar de PCI gaan. Vervolgens krijgen de deelnemers dagelijkse onderhoudsdoses prasugrel tot dag 30. Deelnemers die ouder zijn dan of gelijk zijn aan 75 jaar of die een lichaamsgewicht van minder dan 60 kg hebben, krijgen dagelijks een orale dosis van 5 mg. Alle anderen krijgen gedurende 30 dagen een orale dagelijkse onderhoudsdosis van 10 mg.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
4033
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Bonheiden, België, 2820
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Alberta
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Ontario
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Legnano, Italië, 20025
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Lucca, Italië
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Perugia, Italië, 06156
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Pisa, Italië, 56100
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Prato, Italië, 50047
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Venezia, Italië, 30035
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Adana, Kalkoen, 1330
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Ankara, Kalkoen, 06520
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Antalya, Kalkoen, 07070
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Fatih, Kalkoen, 34300
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Isparta, Kalkoen, 32100
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Istanbul, Kalkoen, 34303
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Kayseri, Kalkoen, 38039
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Kocaeli, Kalkoen, 41900
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Sisli, Kalkoen, 34381
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Liepaja, Letland, 3414
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Riga, Letland, 1038
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Kaunas, Litouwen, LT-50009
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Klaipedos, Litouwen, 92288
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Vilnius, Litouwen, LT-08661
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Amsterdam, Nederland, 1081 HV
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Eindhoven, Nederland, 5623 EJ
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Leeuwarden, Nederland, 8934 AD
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Nieuwegein, Nederland, 3435 CM
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Nijmegen, Nederland, 6500 HB
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Tiel, Nederland, 4002 WP
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Zwolle, Nederland, 8025 AB
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Braunau Am Inn, Oostenrijk, 5280
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Graz, Oostenrijk, 8020
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Linz, Oostenrijk, 4020
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Vienna, Oostenrijk, A1090
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Belchatow, Polen, 97-400
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Chrzanow, Polen, 32-500
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Grodzisk Mazowiecki, Polen, 05-825
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Katowice, Polen, 40-635
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Klodzko, Polen, 57-300
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Krakow, Polen, 31-501
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Lodz, Polen, 91-347
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Lublin, Polen, 20-954
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Mielec, Polen, 39-300
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Naleczow, Polen, 24-140
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Nowy Sacz, Polen, 33-300
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Nowy Targ, Polen, 34-400
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Nysa, Polen, 48-300
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Ostrowiec Swietokrzyski, Polen, 27-400
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Oswiecim, Polen, 32-600
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Polanica-Zdroj, Polen, 57-320
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Pulawy, Polen, 24-100
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Radom, Polen, 26-617
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Sanok, Polen, 38-500
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Stalowa Wola, Polen, 37-450
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Starogard Gdanski, Polen, 82-200
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Tarnow, Polen, 33-100
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Warsaw, Polen, 04-628
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Wejherowo, Polen, 84-200
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Wroclaw, Polen, 53-114
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Braga, Portugal, 4710-243
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Carnaxide, Portugal, 2794-006
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Faro, Portugal, 8000-386
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Leiria, Portugal, 2410-197
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Bucharest, Roemenië, 050098
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Targu Mures, Roemenië, 540136
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Banska Bystrica, Slowakije, 97401
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Kosice, Slowakije, 04011
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Nitra, Slowakije, 94901
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Brno, Tsjechische Republiek, 625 00
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Hradec Kralove, Tsjechische Republiek, 500 05
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Olomouc, Tsjechische Republiek, 775 20
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Plzen, Tsjechische Republiek, 30460
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Prague, Tsjechische Republiek, 169 02
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Usti Nad Labem, Tsjechische Republiek, 40113
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Goteborg, Zweden, 413 45
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusiecriteria:
- Heb een acuut coronair syndroom bestaande uit niet-ST-segmentelevatie met verhoogd troponine
- Gepland voor coronaire angiografie/PCI groter dan of gelijk aan 2 en minder dan 24 uur vanaf het tijdstip van geplande randomisatie, maar niet meer dan 48 uur vanaf randomisatie
- Moet in aanmerking komen voor behandeling met prasugrel, aspirine (ASA) en een glycoproteïne IIb/IIIa-receptorremmer (GPIIb/IIIa) volgens de respectieve labels
- Mag een onderhoudsdosering van 75 mg clopidogrel krijgen en moet kunnen overstappen op prasugrel
- Moet ingeschreven zijn bij een hartkatheterisatielaboratoriumziekenhuis of bij een ziekenhuis/ambulancedienst aangesloten bij een hartkatheterisatielaboratoriumziekenhuis
Uitsluitingscriteria:
- Aanwezig met ST-segment elevatie myocardinfarct (STEMI) op het moment van binnenkomst of randomisatie
- Heb cardiogene shock
- Heb refractaire ventriculaire aritmieën
- Heb New York Heart Association (NYHA) Klasse IV congestief hartfalen (CHF)
- Hartstilstand hebben gehad binnen 1 week na binnenkomst of randomisatie in de studie
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Geen voorbehandeling
Een orale oplaaddosis placebo wordt gegeven op het moment van diagnose en een orale oplaaddosis van 60 milligram (mg) prasugrel wordt gegeven op het moment van PCI, gevolgd door een orale dagelijkse onderhoudsdosis van 5 mg of 10 mg prasugrel gedurende 30 dagen.
|
Oraal toegediend
Andere namen:
Eenmaal oraal toegediend
|
|
Experimenteel: Gesplitste laaddosis
Een orale oplaaddosis prasugrel van 30 mg wordt gegeven bij de diagnose en een orale dosis prasugrel van 30 mg wordt gegeven op het moment van PCI, gevolgd door een orale dagelijkse onderhoudsdosis van 5 mg of 10 mg prasugrel gedurende 30 dagen
|
Oraal toegediend
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Het percentage deelnemers met optreden van cardiovasculaire (CV) dood, myocardinfarct (MI), beroerte, dringende revascularisatie (UR) of Glycoproteïne (GP) IIb/IIIa-remmer Bailout
Tijdsspanne: Eerste oplaaddosis (LD) tot 7 dagen na de eerste LD
|
Het percentage deelnemers is het totale aantal deelnemers dat een CV-overlijden, MI, beroerte, UR of GPIIb/IIIa-inhibitor bailout ervaart, gedeeld door het aantal deelnemers in de behandelingsarm vermenigvuldigd met 100.
Eindpuntgebeurtenissen werden beoordeeld door de Clinical Endpoint Committee.
|
Eerste oplaaddosis (LD) tot 7 dagen na de eerste LD
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Percentage deelnemers met overlijden door alle oorzaken, myocardinfarct (MI), beroerte of volledige coronaire bypass-transplantaat (CABG) en niet-CABG-trombolyse bij myocardinfarct (TIMI) ernstige bloeding
Tijdsspanne: Eerste oplaaddosis (LD) tot 7 dagen na de eerste LD
|
Het percentage deelnemers is het totale aantal deelnemers dat een overlijden door alle oorzaken, MI, beroerte of CABG en niet-CABG TIMI ernstige bloeding doormaakt, gedeeld door het aantal deelnemers in de behandelingsarm vermenigvuldigd met 100.
Eindpuntgebeurtenissen werden beoordeeld door de Clinical Endpoint Committee.
|
Eerste oplaaddosis (LD) tot 7 dagen na de eerste LD
|
|
Percentage deelnemers met incidentie van cardiovasculaire (CV) dood, myocardinfarct (MI) of beroerte gedurende 30 dagen vanaf de eerste oplaaddosis (LD)
Tijdsspanne: Eerste LD tot 30 dagen na eerste LD
|
Het percentage deelnemers is het totale aantal deelnemers dat een CV-overlijden, MI of beroerte ervaart, gedeeld door het aantal deelnemers in de behandelingsarm vermenigvuldigd met 100.
Eindpuntgebeurtenissen werden beoordeeld door de Clinical Endpoint Committee.
|
Eerste LD tot 30 dagen na eerste LD
|
|
Percentage deelnemers met incidentie van cardiovasculaire (CV) dood of myocardinfarct (MI) gedurende 30 dagen vanaf de eerste oplaaddosis (LD)
Tijdsspanne: Eerste LD tot 30 dagen na eerste LD
|
Het percentage deelnemers is het totale aantal deelnemers met een CV-overlijden of MI gedeeld door het aantal deelnemers in de behandelarm vermenigvuldigd met 100.
Eindpuntgebeurtenissen werden beoordeeld door de Clinical Endpoint Committee.
|
Eerste LD tot 30 dagen na eerste LD
|
|
Percentage deelnemers met incidentie van cardiovasculaire (CV) dood, myocardinfarct (MI) of urgente revascularisatie (UR) gedurende 30 dagen vanaf de eerste oplaaddosis (LD)
Tijdsspanne: Eerste LD tot 30 dagen na eerste LD
|
Het percentage deelnemers is het totale aantal deelnemers dat een CV-overlijden, MI of UR doormaakt, gedeeld door het aantal deelnemers in de behandelarm vermenigvuldigd met 100.
Eindpuntgebeurtenissen werden beoordeeld door de Clinical Endpoint Committee.
|
Eerste LD tot 30 dagen na eerste LD
|
|
Percentage deelnemers met incidentie van cardiovasculaire (CV) dood tot 30 dagen na de eerste oplaaddosis (LD)
Tijdsspanne: Eerste LD tot 30 dagen na eerste LD
|
Het percentage deelnemers is het totaal aantal deelnemers met CV overlijden gedeeld door het aantal deelnemers in de behandelarm vermenigvuldigd met 100.
Eindpuntgebeurtenissen werden beoordeeld door de Clinical Endpoint Committee.
|
Eerste LD tot 30 dagen na eerste LD
|
|
Percentage deelnemers met incidentie van definitieve of waarschijnlijke stenttrombose (ST) volgens de criteria van het Academic Research Consortium (ARC) gedurende 30 dagen vanaf de eerste oplaaddosis (LD)
Tijdsspanne: Eerste LD tot 30 dagen na eerste LD
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ARC-criteria werden gebruikt om ST te definiëren.
Definitieve ST is angiografische of pathologische bevestiging van gedeeltelijke of totale trombotische occlusie in het peri-stentgebied en ten minste een van de volgende aanvullende criteria: acute ischemische symptomen; ischemische veranderingen in het elektrocardiogram; verhoogde cardiale biomarkers.
Waarschijnlijke ST is elk onverklaarbaar overlijden binnen 30 dagen na stentimplantatie; elk MI, dat verband houdt met gedocumenteerde acute ischemie in het territorium van de geïmplanteerde stent zonder angiografische bevestiging van ST en zonder enige andere duidelijke oorzaak.
Het percentage deelnemers is het totale aantal deelnemers met een definitieve of waarschijnlijke stenttrombose gedeeld door het aantal deelnemers in de behandelarm vermenigvuldigd met 100.
Eindpuntgebeurtenissen werden beoordeeld door de Clinical Endpoint Committee.
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Eerste LD tot 30 dagen na eerste LD
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Percentage deelnemers met overlijden door alle oorzaken, myocardinfarct (MI), beroerte of volledige coronaire bypass-transplantaat (CABG) en niet-CABG-trombolyse bij myocardinfarct (TIMI) Ernstige bloeding gedurende 30 dagen vanaf de eerste oplaaddosis (LD)
Tijdsspanne: Eerste LD tot 30 dagen na eerste LD
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Het percentage deelnemers is het totale aantal deelnemers dat een overlijden door alle oorzaken, MI, beroerte of CABG en niet-CABG TIMI ernstige bloeding doormaakt, gedeeld door het aantal deelnemers in de behandelingsarm vermenigvuldigd met 100.
Eindpuntgebeurtenissen werden beoordeeld door de Clinical Endpoint Committee.
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Eerste LD tot 30 dagen na eerste LD
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Verandering in gestandaardiseerd troponine van baseline naar percutane coronaire interventie (PCI)
Tijdsspanne: Baseline, vóór PCI (niet meer dan 48 uur na randomisatie)
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Gestandaardiseerd troponine wordt gedefinieerd als de verhouding van de geteste troponinewaarde gedeeld door de bovengrens van normaal (ULN).
Least Squares (LS)-gemiddelden werden verkregen uit een analyse van covariantie (ANCOVA)-model met behandeling als een vast effect en basislijn gestandaardiseerd troponine als een covariabele.
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Baseline, vóór PCI (niet meer dan 48 uur na randomisatie)
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Percentage deelnemers met incidentie van alle coronaire bypass-transplantaten (CABG) of niet-CABG-trombolyse bij myocardinfarct (TIMI) Ernstige bloedingen
Tijdsspanne: Eerste oplaaddosis (LD) tot 7 dagen na de eerste LD
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Het percentage deelnemers is het totale aantal deelnemers dat een CABG of niet-CABG TIMI ernstige bloeding doormaakt, gedeeld door het aantal deelnemers in de behandelingsarm vermenigvuldigd met 100.
Eindpuntgebeurtenissen werden beoordeeld door de Clinical Endpoint Committee.
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Eerste oplaaddosis (LD) tot 7 dagen na de eerste LD
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Samenvatting van overlijden door alle oorzaken
Tijdsspanne: Randomisatie gedurende 30 dagen
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Alle sterfgevallen, ongeacht mogelijke verwantschap, werden beoordeeld door de Clinical Endpoint Committee (CEC) en worden in deze tabel vermeld.
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Randomisatie gedurende 30 dagen
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
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Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 december 2009
Primaire voltooiing (Werkelijk)
1 januari 2013
Studie voltooiing (Werkelijk)
1 februari 2013
Studieregistratiedata
Eerst ingediend
17 november 2009
Eerst ingediend dat voldeed aan de QC-criteria
17 november 2009
Eerst geplaatst (Schatting)
18 november 2009
Updates van studierecords
Laatste update geplaatst (Schatting)
28 februari 2014
Laatste update ingediend die voldeed aan QC-criteria
17 januari 2014
Laatst geverifieerd
1 januari 2014
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 12918
- H7T-MC-TADF (Andere identificatie: Eli Lilly and Company)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .