A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST Elevation Myocardial Infarction
NCT ID: NCT01015287
Last Updated: 2014-02-28
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
4033 participants
Study Classification
INTERVENTIONAL
Study Start Date
2009-12-31
Study Completion Date
2013-02-28
Brief Summary
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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).
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Detailed Description
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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.
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.
Conditions
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Acute Coronary Syndromes
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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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.
Group Type
EXPERIMENTAL
Placebo
Intervention Type
DRUG
Administered once orally
Prasugrel
Intervention Type
DRUG
Administered orally
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
Group Type
EXPERIMENTAL
Prasugrel
Intervention Type
DRUG
Administered orally
Interventions
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Placebo
Administered once orally
Intervention Type
DRUG
Prasugrel
Administered orally
Intervention Type
DRUG
Other Intervention Names
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LY640315
Efient
Effient
CS-747
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Daiichi Sankyo Co., Ltd.
INDUSTRY
Sponsor Role
collaborator
Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
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Haifa, , Israel
Site Status
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Nahariya, , Israel
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Tel Aviv, , Israel
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Tiberias, , Israel
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Arezzo, , Italy
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Chieti, , Italy
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Grosseto, , Italy
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Legnano, , Italy
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Lucca, , Italy
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Massa, , Italy
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Monza, , Italy
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Napoli, , Italy
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Pavia, , Italy
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Perugia, , Italy
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Pisa, , Italy
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Prato, , Italy
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Reggio Emilia, , Italy
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Rome, , Italy
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Torino, , Italy
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Udine, , Italy
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Venezia, , Italy
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Liepāja, , Latvia
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Riga, , Latvia
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Kaunas, , Lithuania
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Klaipedos, , Lithuania
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Vilnius, , Lithuania
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Amsterdam, , Netherlands
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Eindhoven, , Netherlands
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Leeuwarden, , Netherlands
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Nieuwegein, , Netherlands
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Nijmegen, , Netherlands
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Tiel, , Netherlands
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Zwolle, , Netherlands
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Bełchatów, , Poland
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Chrzanów, , Poland
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Grodzisk Mazowiecki, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Kłodzko, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Mielec, , Poland
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Nałęczów, , Poland
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Nowy Sącz, , Poland
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Nowy Targ, , Poland
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Nysa, , Poland
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Ostrowiec Świętokrzyski, , Poland
Site Status
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Oświęcim, , Poland
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Polanica-Zdrój, , Poland
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Puławy, , Poland
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Radom, , Poland
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Sanok, , Poland
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Stalowa Wola, , Poland
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Starogard Gdański, , Poland
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Tarnów, , Poland
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Warsaw, , Poland
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Wejherowo, , Poland
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Wroclaw, , Poland
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Braga, , Portugal
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Carnaxide, , Portugal
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Faro, , Portugal
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Leiria, , Portugal
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Bucharest, , Romania
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Târgu Mureş, , Romania
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Banská Bystrica, , Slovakia
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Košice, , Slovakia
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Nitra, , Slovakia
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Gothenburg, , Sweden
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Adana, , Turkey (Türkiye)
Site Status
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Ankara, , Turkey (Türkiye)
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Antalya, , Turkey (Türkiye)
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Fatih, , Turkey (Türkiye)
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Isparta, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
Site Status
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Kayseri, , Turkey (Türkiye)
Site Status
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Kocaeli, , Turkey (Türkiye)
Site Status
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Şişli, , Turkey (Türkiye)
Site Status
Countries
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Austria
Belgium
Canada
Czechia
Finland
France
Germany
Hungary
Israel
Italy
Latvia
Lithuania
Netherlands
Poland
Portugal
Romania
Slovakia
Sweden
Turkey (Türkiye)
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Other Identifiers
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H7T-MC-TADF
Identifier Type: OTHER
Identifier Source: secondary_id
12918
Identifier Type: -
Identifier Source: org_study_id
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PHASE2
Telmisartan Versus Ramipril After Acute Coronary Syndrome
NCT00702936
UNKNOWN
PHASE4
DLBS1033 for Acute NSTEMI Without Early Coronary Revascularization
NCT02146664
WITHDRAWN
PHASE2/PHASE3
A Research Study to Evaluate the Efficacy and Safety of SGC001 in Patients With Anterior Wall ST-Segment Elevation Myocardial Infarction
NCT07306182
NOT_YET_RECRUITING
PHASE2
Nitric Oxide in Myocardial Infarction Size
NCT00568061
TERMINATED
PHASE2
Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes (ACS)
NCT00093158
COMPLETED
PHASE3
Colchicine's Efficacy in MI Patients: Comparing PCI and Non-Reperfusion Approaches
NCT06426537
COMPLETED
EARLY_PHASE1
Pharmacogenetic Approach to Anti-platelet Therapy for the Treatment of ST-segment Elevation Myocardial Infarction (STEMI)
NCT01452139
COMPLETED
PHASE2/PHASE3
Differential Effect of Ticagrelor Versus Prasugrel on the Adenosine-induced Coronary Vasodilatory Responses in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention
NCT01642966
COMPLETED
PHASE4
Sodium Thiosulfate to Preserve Cardiac Function in STEMI
NCT02899364
UNKNOWN
PHASE2
Bivalirudin/Prasugrel Versus Abciximab/Clopidogrel in Patients Presenting With STEMI
NCT01158846
UNKNOWN
PHASE4
Safety and Tolerability of Sodium Thiosulfate in Patients With an ACS Undergoing CAG Via Trans-radial Approach.
NCT03017963
COMPLETED
PHASE1/PHASE2
Acute Episodes in Chronic Stable Angina: Assessment of the Use of the Coronary Vasodilator Propatyl Nitrate.
NCT02315976
COMPLETED
PHASE4
Implementing Precision Medicine Approaches to Guide Anti-platelet Selection
NCT04090281
UNKNOWN
PHASE4
Comparison of Prasugrel and Ticagrelor in the Treatment of Acute Myocardial Infarction
NCT02808767
COMPLETED
PHASE4