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

NCT01015287 | Completed Phase 3 Results DMC

• 2 other identifiers: 12918H7T-MC-TADF
• Study Type: interventional
• Target: 4,033
• Locations: 19 countries
• Sites: 153

Brief Summary

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).

Conditions

Acute Coronary Syndromes

Keywords

Acute Coronary Syndromes; Heart Disease; Percutaneous Coronary Intervention; P2Y12; NSTEMI

Outcome Measures

Primary Outcomes (1)

• The Percentage of Participants With Occurrence of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Urgent Revascularization (UR), or Glycoprotein (GP) IIb/IIIa Inhibitor Bailout

  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 Outcomes (9)

• 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

  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)

  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)

  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)

  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)

  First LD through 30 days after first LD

Other Outcomes (1)

• Summary of All-Cause Death

  Randomization through 30 days

Study Arms (2)

Non pre-treatment

EXPERIMENTAL

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: Placebo; Drug: Prasugrel

Split Loading Dose

EXPERIMENTAL

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

Interventions

Placebo DRUG

Administered once orally

Non pre-treatment

Prasugrel DRUG

Administered orally

Also known as: LY640315, Efient, Effient, CS-747

Non pre-treatment; Split Loading Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Daiichi Sankyo Co., Ltd.: collaborator

Study Sites (153)

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Braunau am Inn, 5280, Austria

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Graz, 8020, Austria

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Linz, 4020, Austria

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Vienna, A1090, Austria

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Bonheiden, 2820, Belgium

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Bruges, 8000, Belgium

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Charleroi, 6000, Belgium

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Genk, 3600, Belgium

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Leuven, 3000, Belgium

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Yvoir, 5530, Belgium

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Calgary, Alberta, T2N 2T9, Canada

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Vancouver, British Columbia, Vancouver, Canada

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Toronto, Ontario, M5B 1W8, Canada

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Montreal, Quebec, H4J 1C5, Canada

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Sainte-Foy, Quebec, G1V 4G5, Canada

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Saskatoon, Saskatchewan, S7N 0W8, Canada

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Brno, 625 00, Czechia

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Hradec Králové, 500 05, Czechia

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Olomouc, 775 20, Czechia

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Pilsen, 30460, Czechia

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Prague, 169 02, Czechia

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Ústí nad Labem, 40113, Czechia

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Turku, 20521, Finland

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Bastia, 20600, France

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Bron, 69500, France

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Caluire-et-Cuire, 69300, France

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Cannes, 06401, France

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Châteauroux, 36019, France

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Corbeil-Essonnes, 91106, France

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Lagny-sur-Marne, 77405, France

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Le Coudray, 28630, France

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Lille, 59037, France

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Lyon, 69317, France

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Marseille, 13015, France

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Metz, 57085, France

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Metz-Tessy, 74370, France

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Montauban, 82017, France

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Montreuil, 93105, France

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Nîmes, 30029, France

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Paris, 75743, France

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Pau, 64046, France

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Pierre-Bénite, 69495, France

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Rennes, 35033, France

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Toulouse, 31076, France

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Valence, 26953, France

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Vannes, 56017, France

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Vienne, 38209, France

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Villeurbanne, 69100, France

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Bad Nauheim, 61231, Germany

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Bad Segeberg, 23795, Germany

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Bochum, 44791, Germany

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Bonn, 53105, Germany

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Coburg, 96450, Germany

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Dachau, 85221, Germany

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Eutin, 23701, Germany

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Frankfurt, 60596, Germany

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Halle, 06120, Germany

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Hamburg, 20099, Germany

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Hanover, 30625, Germany

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Heidelberg, D-69120, Germany

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Jena, 07740, Germany

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Kassel, 34125, Germany

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Leipzig, 04289, Germany

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Ludwigshafen, 67063, Germany

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Mainz, 55101, Germany

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Munich, 80336, Germany

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Rastatt, 76437, Germany

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Rostock, 18057, Germany

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Villingen-Schwenningen, 78050, Germany

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Balatonfüred, 8230, Hungary

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Budapest, 1096, Hungary

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Pécs, 7624, Hungary

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Zalaegerszeg, 8900, Hungary

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Beer Yaakov, 70300, Israel

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Haifa, 34362, Israel

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Jerusalem, 91120, Israel

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Kfar Saba, 44281, Israel

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Nahariya, 22100, Israel

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Tel Aviv, 64239, Israel

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Tiberias, 15208, Israel

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Arezzo, 52100, Italy

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Chieti, 66013, Italy

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Grosseto, 58100, Italy

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Legnano, 20025, Italy

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Lucca, Italy

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Massa, 54100, Italy

Location

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Monza, 20900, Italy

Location

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Napoli, 80100, Italy

Location

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Pavia, 27100, Italy

Location

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Perugia, 06156, Italy

Location

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Pisa, 56100, Italy

Location

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Prato, 50047, Italy

Location

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Reggio Emilia, 42100, Italy

Location

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Rome, 00100, Italy

Location

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Torino, 10100, Italy

Location

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Udine, 33100, Italy

Location

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Venezia, 30035, Italy

Location

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Liepāja, 3414, Latvia

Location

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Riga, 1038, Latvia

Location

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Kaunas, LT-50009, Lithuania

Location

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Klaipedos, 92288, Lithuania

Location

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Vilnius, LT-08661, Lithuania

Location

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Amsterdam, 1081 HV, Netherlands

Location

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Eindhoven, 5623 EJ, Netherlands

Location

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Leeuwarden, 8934 AD, Netherlands

Location

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Nieuwegein, 3435 CM, Netherlands

Location

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Nijmegen, 6500 HB, Netherlands

Location

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Tiel, 4002 WP, Netherlands

Location

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Zwolle, 8025 AB, Netherlands

Location

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Bełchatów, 97-400, Poland

Location

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Chrzanów, 32-500, Poland

Location

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Grodzisk Mazowiecki, 05-825, Poland

Location

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Katowice, 40-635, Poland

Location

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Krakow, 31-501, Poland

Location

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Kłodzko, 57-300, Poland

Location

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Lodz, 91-347, Poland

Location

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Lublin, 20-954, Poland

Location

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Mielec, 39-300, Poland

Location

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Nałęczów, 24-140, Poland

Location

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Nowy Sącz, 33-300, Poland

Location

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Nowy Targ, 34-400, Poland

Location

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Nysa, 48-300, Poland

Location

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Ostrowiec Świętokrzyski, 27-400, Poland

Location

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Oświęcim, 32-600, Poland

Location

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Polanica-Zdrój, 57-320, Poland

Location

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Puławy, 24-100, Poland

Location

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Radom, 26-617, Poland

Location

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Sanok, 38-500, Poland

Location

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Stalowa Wola, 37-450, Poland

Location

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Starogard Gdański, 82-200, Poland

Location

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Tarnów, 33-100, Poland

Location

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Warsaw, 04-628, Poland

Location

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Wejherowo, 84-200, Poland

Location

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Wroclaw, 53-114, Poland

Location

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Braga, 4710-243, Portugal

Location

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Carnaxide, 2794-006, Portugal

Location

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Faro, 8000-386, Portugal

Location

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Leiria, 2410-197, Portugal

Location

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Bucharest, 050098, Romania

Location

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Târgu Mureş, 540136, Romania

Location

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Banská Bystrica, 97401, Slovakia

Location

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Košice, 04011, Slovakia

Location

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Nitra, 94901, Slovakia

Location

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Gothenburg, 413 45, Sweden

Location

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Adana, 1330, Turkey (Türkiye)

Location

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Ankara, 06520, Turkey (Türkiye)

Location

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Antalya, 07070, Turkey (Türkiye)

Location

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Fatih, 34300, Turkey (Türkiye)

Location

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Isparta, 32100, Turkey (Türkiye)

Location

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Istanbul, 34303, Turkey (Türkiye)

Location

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Kayseri, 38039, Turkey (Türkiye)

Location

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Kocaeli, 41900, Turkey (Türkiye)

Location

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Şişli, 34381, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 30819358 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.

  PMID: 27151605 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.

  PMID: 26542513 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.

  PMID: 26060122 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.

  PMID: 25524333 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.

  PMID: 23991622 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.

  PMID: 21473962 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Heart Diseases; Non-ST Elevated Myocardial Infarction

Interventions

Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2009
• First Posted: November 18, 2009
• Study Start: December 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 28, 2014
• Results First Posted: February 28, 2014

Record last verified: 2014-01

Locations

IL (7); TU (9); FI (1); LA (2); LI (3); AU (4); IT (17); PT (4); BE (6); SL (3); NL (7); CA (6); CZ (6); HU (4); FR (25); DE (21); PL (25); RO (2); SE (1)