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

This study has been completed.
Sponsor:
Collaborator:
Daiichi Sankyo Co., Ltd.
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01015287
First received: November 17, 2009
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

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).


Condition Intervention Phase
Acute Coronary Syndromes
Drug: Placebo
Drug: Prasugrel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • Change in Standardized Troponin From Baseline to Percutaneous Coronary Intervention (PCI) [ Time Frame: Baseline, before PCI (not greater than 48 hours after randomization) ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.


Other Outcome Measures:
  • Summary of All-Cause Death [ Time Frame: Randomization through 30 days ] [ Designated as safety issue: Yes ]
    All deaths, regardless of possible relatedness, were adjudicated by the Clinical Endpoint Committee (CEC) and are reported in this table.


Enrollment: 4033
Study Start Date: December 2009
Study Completion Date: February 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Placebo
Administered once orally
Drug: Prasugrel
Administered orally
Other Names:
  • LY640315
  • Efient
  • Effient
  • CS-747
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:
  • LY640315
  • Efient
  • Effient
  • CS-747

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01015287

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Locations
Austria
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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
Belgium
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Bonheiden, Belgium, 2820
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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
Canada, Alberta
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Canada, Saskatchewan
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Czech Republic
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Finland
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Bron, France, 69500
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Lille, France, 59037
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Lyon, France, 69317
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Nimes, France, 30029
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Paris, France, 75743
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Rennes, France, 35033
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Villeurbanne, France, 69100
Germany
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Hamburg, Germany, 20099
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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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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
Hungary
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Balatonfured, Hungary, 8230
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Budapest, Hungary, 1096
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Pecs, Hungary, 7624
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Zalaegerszeg, Hungary, 8900
Israel
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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
Italy
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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
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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
Latvia
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Liepaja, Latvia, 3414
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Riga, Latvia, 1038
Lithuania
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Kaunas, Lithuania, LT-50009
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Klaipedos, Lithuania, 92288
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Vilnius, Lithuania, LT-08661
Netherlands
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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
Poland
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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
Portugal
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Braga, Portugal, 4710-243
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Carnaxide, Portugal, 2794-006
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Faro, Portugal, 8000-386
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Leiria, Portugal, 2410-197
Romania
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Bucharest, Romania, 050098
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Targu Mures, Romania, 540136
Slovakia
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Banska Bystrica, Slovakia, 97401
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Kosice, Slovakia, 04011
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Nitra, Slovakia, 94901
Sweden
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Goteborg, Sweden, 413 45
Turkey
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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
Sponsors and Collaborators
Eli Lilly and Company
Daiichi Sankyo Co., Ltd.
Investigators
Study Director: 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
  More Information

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01015287     History of Changes
Other Study ID Numbers: 12918, H7T-MC-TADF
Study First Received: November 17, 2009
Results First Received: January 17, 2014
Last Updated: January 17, 2014
Health Authority: European Union: European Medicines Agency

Keywords provided by Eli Lilly and Company:
Acute Coronary Syndromes
Heart Disease
Percutaneous Coronary Intervention
P2Y12
NSTEMI

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Prasugrel
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 11, 2014