A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST Elevation Myocardial Infarction (ACCOAST)

January 17, 2014 updated by: Eli Lilly and Company

A Comparison of Prasugrel at the Time of Percutaneous Coronary Intervention (PCI) Or as Pretreatment At the Time of Diagnosis in Patients With Non-ST-Elevation Myocardial Infarction (NSTEMI): The ACCOAST Study

The purpose of this trial is to investigate the potential benefits/risks regarding pretreatment with prasugrel in non-ST-elevation myocardial infarction (NSTEMI) participants with elevated troponin scheduled for coronary angiography/percutaneous coronary intervention (PCI).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This trial consists of two arms. One arm is a non pre-treatment arm. Participants in this arm will receive placebo immediately after NSTEMI diagnosis and prior to the diagnostic coronary angiography. A 60 mg prasugrel loading dose will be given immediately after coronary angiography when proceeding to PCI. Subsequently, participants will receive daily maintenance doses of prasugrel until day 30. Participants who are greater than or equal to 75 years of age or who have a body weight less than 60 kilograms (kg) will receive 5 mg oral dose daily. All others will receive a 10 mg oral daily maintenance dose for 30 days.

The other arm is a pre-treatment arm where participants will receive a split loading dose regimen with 30 mg of prasugrel administered immediately after NSTEMI diagnosis and prior to diagnostic coronary angiography. The remainder of the loading dose (30 mg) will be administered when the participants are proceeding to PCI. Subsequently, participants will receive daily maintenance doses of prasugrel until day 30. Participants who are greater than or equal to 75 years of age or who have a body weight less than 60 kg will receive 5 mg oral dose daily. All others will receive a 10 mg oral daily maintenance dose for 30 days.

Study Type

Interventional

Enrollment (Actual)

4033

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Braunau Am Inn, Austria, 5280
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      • Graz, Austria, 8020
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      • Linz, Austria, 4020
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      • Vienna, Austria, A1090
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  • Belgium
      • Bonheiden, Belgium, 2820
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      • Brugge, Belgium, 8000
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      • Charleroi, Belgium, 6000
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      • Genk, Belgium, 3600
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      • Leuven, Belgium, 3000
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      • Yvoir, Belgium, 5530
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  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
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    • British Columbia
      • Vancouver, British Columbia, Canada, Vancouver
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    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
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    • Quebec
      • Montreal, Quebec, Canada, H4J 1C5
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      • Sainte-Foy, Quebec, Canada, G1V 4G5
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    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
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  • Czech Republic
      • Brno, Czech Republic, 625 00
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      • Hradec Kralove, Czech Republic, 500 05
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      • Olomouc, Czech Republic, 775 20
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      • Plzen, Czech Republic, 30460
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      • Prague, Czech Republic, 169 02
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      • Usti Nad Labem, Czech Republic, 40113
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  • Finland
      • Turku, Finland, 20521
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  • France
      • Bastia, France, 20600
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      • Bron, France, 69500
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      • Caluire Et Cuire, France, 69300
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      • Cannes Cedex, France, 06401
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      • Chateauroux, France, 36019
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      • Corbeil Essonnes, France, 91106
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      • Lagny Sur Marne, France, 77405
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      • Le Coudray, France, 28630
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      • Lille, France, 59037
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      • Lyon, France, 69317
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      • Marseille, France, 13015
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      • Metz, France, 57085
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      • Metz Tessy, France, 74370
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      • Montauban, France, 82017
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      • Montreuil, France, 93105
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      • Nimes, France, 30029
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      • Paris, France, 75743
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      • Pau Cedex, France, 64046
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      • Pierre Benite, France, 69495
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      • Rennes, France, 35033
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      • Toulouse, France, 31076
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      • Valence, France, 26953
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      • Vannes, France, 56017
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      • Vienne, France, 38209
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      • Villeurbanne, France, 69100
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  • Germany
      • Bad Nauheim, Germany, 61231
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      • Bad Segeberg, Germany, 23795
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      • Bochum, Germany, 44791
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      • Bonn, Germany, 53105
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      • Coburg, Germany, 96450
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      • Dachau, Germany, 85221
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      • Eutin, Germany, 23701
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      • Frankfurt, Germany, 60596
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      • Halle, Germany, 06120
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      • Hamburg, Germany, 20099
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      • Hannover, Germany, 30625
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      • Heidelberg, Germany, D-69120
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      • Jena, Germany, 07740
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      • Kassel, Germany, 34125
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      • Leipzig, Germany, 04289
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      • Ludwigshafen, Germany, 67063
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      • Mainz, Germany, 55101
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      • Munich, Germany, 80336
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      • Rastatt, Germany, 76437
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      • Rostock, Germany, 18057
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      • Villingen-Schwenningen, Germany, 78050
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  • Hungary
      • Balatonfured, Hungary, 8230
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      • Budapest, Hungary, 1096
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      • Pecs, Hungary, 7624
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      • Zalaegerszeg, Hungary, 8900
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  • Israel
      • Beer Yaakov, Israel, 70300
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      • Haifa, Israel, 34362
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      • Jerusalem, Israel, 91120
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      • Kfar Saba, Israel, 44281
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      • Nahariya, Israel, 22100
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      • Tel-Aviv, Israel, 64239
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      • Tiberias, Israel, 15208
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  • Italy
      • Arezzo, Italy, 52100
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      • Chieti, Italy, 66013
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      • Grosseto, Italy, 58100
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      • Legnano, Italy, 20025
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      • Lucca, Italy
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      • Massa, Italy, 54100
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      • Monza, Italy, 20900
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      • Napoli, Italy, 80100
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      • Pavia, Italy, 27100
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      • Perugia, Italy, 06156
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      • Pisa, Italy, 56100
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      • Prato, Italy, 50047
        • 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.
      • Reggio Emilia, Italy, 42100
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      • Rome, Italy, 00100
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      • Torino, Italy, 10100
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      • Udine, Italy, 33100
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      • Venezia, Italy, 30035
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  • Latvia
      • Liepaja, Latvia, 3414
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      • Riga, Latvia, 1038
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  • Lithuania
      • Kaunas, Lithuania, LT-50009
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      • Klaipedos, Lithuania, 92288
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      • Vilnius, Lithuania, LT-08661
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  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
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      • Eindhoven, Netherlands, 5623 EJ
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      • Leeuwarden, Netherlands, 8934 AD
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      • Nieuwegein, Netherlands, 3435 CM
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      • Nijmegen, Netherlands, 6500 HB
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      • Tiel, Netherlands, 4002 WP
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      • Zwolle, Netherlands, 8025 AB
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  • Poland
      • Belchatow, Poland, 97-400
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      • Chrzanow, Poland, 32-500
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      • Grodzisk Mazowiecki, Poland, 05-825
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      • Katowice, Poland, 40-635
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      • Klodzko, Poland, 57-300
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      • Krakow, Poland, 31-501
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      • Lodz, Poland, 91-347
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      • Lublin, Poland, 20-954
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      • Mielec, Poland, 39-300
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      • Naleczow, Poland, 24-140
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      • Nowy Sacz, Poland, 33-300
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      • Nowy Targ, Poland, 34-400
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      • Nysa, Poland, 48-300
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      • Ostrowiec Swietokrzyski, Poland, 27-400
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      • Oswiecim, Poland, 32-600
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      • Polanica-Zdroj, Poland, 57-320
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      • Pulawy, Poland, 24-100
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      • Radom, Poland, 26-617
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      • Sanok, Poland, 38-500
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      • Stalowa Wola, Poland, 37-450
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      • Starogard Gdanski, Poland, 82-200
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      • Tarnow, Poland, 33-100
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      • Warsaw, Poland, 04-628
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      • Wejherowo, Poland, 84-200
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      • Wroclaw, Poland, 53-114
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  • Portugal
      • 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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  • Romania
      • Bucharest, Romania, 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.
      • Targu Mures, Romania, 540136
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  • Slovakia
      • Banska Bystrica, Slovakia, 97401
        • 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.
      • Kosice, Slovakia, 04011
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      • Nitra, Slovakia, 94901
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  • Sweden
      • Goteborg, Sweden, 413 45
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  • Turkey
      • Adana, Turkey, 1330
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      • Ankara, Turkey, 06520
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      • Antalya, Turkey, 07070
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      • Fatih, Turkey, 34300
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      • Isparta, Turkey, 32100
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      • Istanbul, Turkey, 34303
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      • Kayseri, Turkey, 38039
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      • Kocaeli, Turkey, 41900
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      • Sisli, Turkey, 34381
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Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have acute coronary syndrome consisting of non-ST-segment elevation with elevated troponin
  • Scheduled for coronary angiography/PCI greater than or equal to 2 and less than 24 hours from time of planned randomization, but no more than 48 hours from randomization
  • Must be eligible for treatment with prasugrel, aspirin (ASA), and a glycoprotein IIb/IIIa receptor (GPIIb/IIIa) inhibitor as per respective labels
  • May be on a maintenance dose of clopidogrel 75 mg and must be able to switch to prasugrel
  • Must be enrolled at a cardiac catheterization laboratory hospital or at a hospital/ambulance service affiliated with a cardiac catheterization laboratory hospital

Exclusion Criteria:

  • Present with ST-segment elevation myocardial infarction (STEMI) at the time of entry or randomization
  • Have cardiogenic shock
  • Have refractory ventricular arrhythmias
  • Have New York Heart Association (NYHA) Class IV congestive heart failure (CHF)
  • Have had cardiac arrest within 1 week of entry or randomization into the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non pre-treatment
A placebo oral loading dose is given at the time of diagnosis and a 60 milligrams (mg) oral loading dose of prasugrel is given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
Drug: Prasugrel
Administered orally
Other Names:
  • Effient
  • LY640315
  • CS-747
  • Efient
Drug: Placebo
Administered once orally
Experimental: Split Loading Dose
A 30 mg oral loading dose of prasugrel is given at diagnosis and a 30 mg oral dose of prasugrel is given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days
Drug: Prasugrel
Administered orally
Other Names:
  • Effient
  • LY640315
  • CS-747
  • Efient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Percentage of Participants With Occurrence of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Urgent Revascularization (UR), or Glycoprotein (GP) IIb/IIIa Inhibitor Bailout
Time Frame: First loading dose (LD) through 7 days after first LD
The percentage of participants is the total number of participants experiencing a CV death, MI, stroke, UR or GPIIb/IIIa Inhibitor bailout divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
First loading dose (LD) through 7 days after first LD

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With All-Cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
Time Frame: First loading dose (LD) through 7 days after first LD
The percentage of participants is the total number of participants experiencing an all-cause death, MI, stroke or CABG and non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
First loading dose (LD) through 7 days after first LD
Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke Through 30 Days From First Loading Dose (LD)
Time Frame: First LD through 30 days after first LD
The percentage of participants is the total number of participants experiencing a CV death, MI, or stroke divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
First LD through 30 days after first LD
Percentage of Participants With Incidence of Cardiovascular (CV) Death or Myocardial Infarction (MI) Through 30 Days From First Loading Dose (LD)
Time Frame: First LD through 30 days after first LD
The percentage of participants is the total number of participants experiencing a CV death or MI divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
First LD through 30 days after first LD
Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Urgent Revascularization (UR) Through 30 Days From First Loading Dose (LD)
Time Frame: First LD through 30 days after first LD
The percentage of participants is the total number of participants experiencing a CV death, MI, or UR divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
First LD through 30 days after first LD
Percentage of Participants With Incidence of Cardiovascular (CV) Death Through 30 Days From First Loading Dose (LD)
Time Frame: First LD through 30 days after first LD
The percentage of participants is the total number of participants experiencing a CV death divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
First LD through 30 days after first LD
Percentage of Participants With Incidence of Definite or Probable Stent Thrombosis (ST) According to the Academic Research Consortium (ARC) Criteria Through 30 Days From First Loading Dose (LD)
Time Frame: First LD through 30 days after first LD
ARC criteria were used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least one of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause. The percentage of participants is the total number of participants experiencing a definite or probable stent thrombosis divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
First LD through 30 days after first LD
Percentage of Participants With All-cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding Through 30 Days From First Loading Dose (LD)
Time Frame: First LD through 30 days after first LD
The percentage of participants is the total number of participants experiencing an all-cause death, MI, stroke or CABG and non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
First LD through 30 days after first LD
Change in Standardized Troponin From Baseline to Percutaneous Coronary Intervention (PCI)
Time Frame: Baseline, before PCI (not greater than 48 hours after randomization)
Standardized troponin is defined as the ratio of the assayed troponin value divided by the upper limit of normal (ULN). Least Squares (LS) means were obtained from an Analysis of Covariance (ANCOVA) model with treatment as a fixed effect and baseline standardized troponin as a covariate.
Baseline, before PCI (not greater than 48 hours after randomization)
Percentage of Participants With Incidence of All Coronary Artery Bypass Graft (CABG) or Non-CABG Thrombolysis In Myocardial Infarction (TIMI) Major Bleeding
Time Frame: First loading dose (LD) through 7 days after first LD
The percentage of participants is the total number of participants experiencing a CABG or non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
First loading dose (LD) through 7 days after first LD

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Summary of All-Cause Death
Time Frame: Randomization through 30 days
All deaths, regardless of possible relatedness, were adjudicated by the Clinical Endpoint Committee (CEC) and are reported in this table.
Randomization through 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Collaborators

Daiichi Sankyo Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

November 17, 2009

First Submitted That Met QC Criteria

November 17, 2009

First Posted (Estimate)

November 18, 2009

Study Record Updates

Last Update Posted (Estimate)

February 28, 2014

Last Update Submitted That Met QC Criteria

January 17, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12918
  • H7T-MC-TADF (Other Identifier: Eli Lilly and Company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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