Acute Coronary SyndromesPhase 3ACCOASTNCT01015287

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

A Phase 3 study testing Prasugrel in people with Acute Coronary Syndromes, run by Eli Lilly and Company at 153 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Coronary Syndromes
What is being tested?: Prasugrel
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 4,033 participants
Where: 153 sitesin 19 countries
Study dates: Dec 2009to Feb 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

153 sites in 19 countries.

Country

City, postcode or hospital

153 sites in 19 countries

France25 sites

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Bastia, 20600
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Bron, 69500
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Caluire-et-Cuire, 69300
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Cannes, 06401
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Châteauroux, 36019
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Corbeil-Essonnes, 91106
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Lagny-sur-Marne, 77405
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Le Coudray, 28630
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Lille, 59037
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Lyon, 69317
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Marseille, 13015
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Metz, 57085
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Metz-Tessy, 74370
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Montauban, 82017
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Montreuil, 93105
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Nîmes, 30029
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Paris, 75743
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Pau, 64046
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Pierre-Bénite, 69495
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Rennes, 35033
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Toulouse, 31076
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Valence, 26953
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Vannes, 56017
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Vienne, 38209
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Villeurbanne, 69100

Other trials in France

Poland25 sites

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Bełchatów, 97-400
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Chrzanów, 32-500
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Grodzisk Mazowiecki, 05-825
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Katowice, 40-635
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Kłodzko, 57-300
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Krakow, 31-501
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Lodz, 91-347
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Lublin, 20-954
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Mielec, 39-300
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Nałęczów, 24-140
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Nowy Sącz, 33-300
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Nowy Targ, 34-400
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Nysa, 48-300
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Ostrowiec Świętokrzyski, 27-400
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Oświęcim, 32-600
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Polanica-Zdrój, 57-320
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Puławy, 24-100
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Radom, 26-617
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Sanok, 38-500
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Stalowa Wola, 37-450
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Starogard Gdański, 82-200
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Tarnów, 33-100
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Warsaw, 04-628
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Wejherowo, 84-200
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Wroclaw, 53-114

Other trials in Poland

Germany21 sites

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Bad Nauheim, 61231
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Bad Segeberg, 23795
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Bochum, 44791
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Bonn, 53105
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Coburg, 96450
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Dachau, 85221
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Eutin, 23701
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Frankfurt, 60596
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Halle, 06120
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Hamburg, 20099
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Hanover, 30625
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Heidelberg, D-69120
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Jena, 07740
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Kassel, 34125
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Leipzig, 04289
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Ludwigshafen, 67063
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Mainz, 55101
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Munich, 80336
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Rastatt, 76437
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Rostock, 18057
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Villingen-Schwenningen, 78050

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Italy17 sites

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Arezzo, 52100
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Chieti, 66013
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Grosseto, 58100
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Legnano, 20025
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Lucca
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Massa, 54100
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Monza, 20900
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Naples, 80100
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Pavia, 27100
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Perugia, 06156
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Pisa, 56100
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Prato, 50047
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Reggio Emilia, 42100
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Rome, 00100
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Torino, 10100
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Udine, 33100
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Venezia, 30035

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Turkey (Türkiye)9 sites

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Adana, 1330
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Ankara, 06520
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Antalya, 07070
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Fatih, 34300
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Isparta, 32100
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Istanbul, 34303
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Kayseri, 38039
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Kocaeli, 41900
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Şişli, 34381

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Israel7 sites

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Beer Yaakov, 70300
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Haifa, 34362
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Jerusalem, 91120
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Kfar Saba, 44281
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Nahariya, 22100
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Tel Aviv, 64239
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Tiberias, 15208

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Netherlands7 sites

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Amsterdam, 1081 HV
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Eindhoven, 5623 EJ
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Leeuwarden, 8934 AD
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Nieuwegein, 3435 CM
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Nijmegen, 6500 HB
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Tiel, 4002 WP
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Zwolle, 8025 AB

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Belgium6 sites

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Bonheiden, 2820
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Bruges, 8000
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Charleroi, 6000
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Genk, 3600
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Leuven, 3000
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Yvoir, 5530

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Canada6 sites

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Calgary, Alberta, T2N 2T9
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Montreal, Quebec, H4J 1C5
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Sainte-Foy, Quebec, G1V 4G5
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Saskatoon, Saskatchewan, S7N 0W8
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Toronto, Ontario, M5B 1W8
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Vancouver, British Columbia, Vancouver

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Czechia6 sites

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Brno, 625 00
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Hradec Králové, 500 05
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Olomouc, 775 20
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Pilsen, 30460
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Prague, 169 02
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Ústí nad Labem, 40113

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Austria4 sites

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Braunau am Inn, 5280
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Graz, 8020
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Linz, 4020
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Vienna, A1090

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Hungary4 sites

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Balatonfüred, 8230
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Budapest, 1096
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Pécs, 7624
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Zalaegerszeg, 8900

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Portugal4 sites

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Braga, 4710-243
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Carnaxide, 2794-006
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Faro, 8000-386
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Leiria, 2410-197

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Lithuania3 sites

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Kaunas, LT-50009
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Klaipedos, 92288
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Vilnius, LT-08661

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Slovakia3 sites

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Banská Bystrica, 97401
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Košice, 04011
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Nitra, 94901

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Latvia2 sites

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Liepāja, 3414
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Riga, 1038

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Romania2 sites

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Bucharest, 050098
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Târgu Mureş, 540136

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Finland1 site

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Turku, 20521

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Sweden1 site

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Gothenburg, 413 45

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About this study

Official title: 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

Read the 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.

Conditions: Acute Coronary Syndromes
Being tested: Placebo, Prasugrel
Keywords: Acute Coronary Syndromes, Heart Disease, Percutaneous Coronary Intervention, P2Y12, NSTEMI
Medical subject headings: Acute Coronary Syndrome, Heart Diseases, Non-ST Elevated Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Administered once orally
PrasugrelDrug
Also called LY640315, Efient, Effient, CS-747
Administered orally

Study groups in NCT01015287
Study group	Role	What they receive
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. Receives: 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 Receives: Drug: Prasugrel

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: First LD through 30 days after first LD
Change in Standardized Troponin From Baseline to Percutaneous Coronary Intervention (PCI)
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.
Measured: 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
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.
Measured: First loading dose (LD) through 7 days after first LD

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2009Feb 2013

First posted18 Nov 2009 (estimated)
Study startDec 2009
Primary completionJan 2013
Study completionFeb 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Acute Coronary SyndromesStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 4,033 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01015287
Sponsor's protocol ID: 12918
Other IDs: H7T-MC-TADF
Acronym: ACCOAST
Status last verified: Jan 2014
First submitted: 17 Nov 2009
Last updated: 28 Feb 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 30819358
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.
PubMed 27151605
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.
PubMed 26542513
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.
PubMed 26060122
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.
PubMed 25524333
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.
PubMed 23991622
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.
PubMed 21473962

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Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease

All Acute Coronary Syndromes trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01015287
Acronym / sponsor ID: ACCOAST / 12918
Conditions: Acute Coronary Syndromes
Keywords: Acute Coronary Syndromes, Heart Disease, Percutaneous Coronary Intervention, P2Y12, NSTEMI
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 4,033 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Daiichi Sankyo Co., Ltd.
Study start: Dec 2009
Primary completion: Jan 2013 (actual)
Study completion: Feb 2013 (actual)
First posted: 18 Nov 2009 (estimated)
Results: Posted 28 Feb 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Non pre-treatment	Experimental	Drug: Placebo, Drug: PrasugrelA 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.
Split Loading Dose	Experimental	Drug: PrasugrelA 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboAdministered once orally	Drug	Non pre-treatment
PrasugrelAlso: LY640315, Efient, Effient, CS-747Administered orally	Drug	Non pre-treatment, Split Loading Dose

Primary outcome

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.

9 secondary outcomes

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
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
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
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
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
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
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
Change in Standardized Troponin From Baseline to Percutaneous Coronary Intervention (PCI)
Time frame: 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

Results and safety

Results posted to the registry on 28 Feb 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Non Pre-treatment	1,996	1,924
Pre-treatment	2,037	1,958

Primary outcome: 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. Number. Unit: percentage of participants

Measure	Non Pre-treatment n = 1996	Pre-treatment n = 2037
Value	9.77	9.97

Population analysed: All randomized participants who received at least 1 dose of study drug.

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Non Pre-treatment	167 of 1,996 (8.4%)	860 of 1,996 (43.1%)	Not reported
Pre-treatment	206 of 2,037 (10.1%)	876 of 2,037 (43%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30819358Silvain 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.
Derived from this study: PubMed 27151605Porto 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.
Derived from this study: PubMed 26542513Dudek 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.
Derived from this study: PubMed 26060122Widimsky 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.
Derived from this study: PubMed 25524333Montalescot 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.
Derived from this study: PubMed 23991622Montalescot 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.
Derived from this study: PubMed 21473962Montalescot 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

153 sites in 19 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Prasugrel in people with Acute Coronary Syndromes, run by Eli Lilly and Company at 153 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 153 sites in France, Poland, Germany, Italy, Turkey (Türkiye) and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01015287, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2014.