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

Last updated: January 17, 2014
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

3

Condition

Myocardial Ischemia

Heart Disease

Angina

Treatment

N/A

Clinical Study ID

NCT01015287
12918
H7T-MC-TADF
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have acute coronary syndrome consisting of non-ST-segment elevation with elevatedtroponin

  • Scheduled for coronary angiography/PCI greater than or equal to 2 and less than 24hours from time of planned randomization, but no more than 48 hours from randomization

  • Must be eligible for treatment with prasugrel, aspirin (ASA), and a glycoproteinIIb/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 toprasugrel

  • Must be enrolled at a cardiac catheterization laboratory hospital or at ahospital/ambulance service affiliated with a cardiac catheterization laboratoryhospital

Exclusion

Exclusion Criteria:

  • Present with ST-segment elevation myocardial infarction (STEMI) at the time of entryor randomization

  • Have cardiogenic shock

  • Have refractory ventricular arrhythmias

  • Have New York Heart Association (NYHA) Class IV congestive heart failure (CHF)

  • Have had cardiac arrest within 1 week of entry or randomization into the study

Study Design

Total Participants: 4033
Study Start date:
December 01, 2009
Estimated Completion Date:
February 28, 2013

Study 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.

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    Beer Yaakov, 70300
    Israel

    Site Not Available

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    Hadera, 38100
    Israel

    Site Not Available

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    Haifa, 34362
    Israel

    Site Not Available

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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

    Site Not Available

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    Catania, 95124
    Italy

    Site Not Available

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    Chieti, 66013
    Italy

    Site Not Available

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    Grosseto, 58100
    Italy

    Site Not Available

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    Legnano, 20025
    Italy

    Site Not Available

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    Lucca,
    Italy

    Site Not Available

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    Mantova, 46100
    Italy

    Site Not Available

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    Massa, 54100
    Italy

    Site Not Available

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    Modena, 41100
    Italy

    Site Not Available

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    Monza, 20900
    Italy

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    Napoli, 80100
    Italy

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    Pavia, 27100
    Italy

    Site Not Available

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    Perugia, 06156
    Italy

    Site Not Available

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    Pisa, 56100
    Italy

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    Prato, 50047
    Italy

    Site Not Available

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    Reggio Emilia, 42100
    Italy

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    Rome, 00100
    Italy

    Site Not Available

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    Torino, 10100
    Italy

    Site Not Available

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    Udine, 33100
    Italy

    Site Not Available

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    Venezia, 30035
    Italy

    Site Not Available

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    Daugavpils, LV -5417
    Latvia

    Site Not Available

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    Liepaja, 3414
    Latvia

    Site Not Available

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    Riga, 1038
    Latvia

    Site Not Available

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    Kaunas, LT-50009
    Lithuania

    Site Not Available

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    Klaipedos, 92288
    Lithuania

    Site Not Available

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    Vilnius, LT-08661
    Lithuania

    Site Not Available

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    Amsterdam, 1081 HV
    Netherlands

    Site Not Available

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    Breda, 4818
    Netherlands

    Site Not Available

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    Eindhoven, 5623 EJ
    Netherlands

    Site Not Available

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    Leeuwarden, 8934 AD
    Netherlands

    Site Not Available

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    Nieuwegein, 3435 CM
    Netherlands

    Site Not Available

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    Nijmegen, 6500 HB
    Netherlands

    Site Not Available

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    Tiel, 4002 WP
    Netherlands

    Site Not Available

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    Zwolle, 8025 AB
    Netherlands

    Site Not Available

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    Belchatow, 97-400
    Poland

    Site Not Available

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    Chrzanow, 32-500
    Poland

    Site Not Available

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    Grodzisk Mazowiecki, 05-825
    Poland

    Site Not Available

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    Katowice, 40-635
    Poland

    Site Not Available

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    Klodzko, 57-300
    Poland

    Site Not Available

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    Koscierzyna, 83-400
    Poland

    Site Not Available

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    Krakow, 31-501
    Poland

    Site Not Available

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    Lodz, 91-347
    Poland

    Site Not Available

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    Lublin, 20-954
    Poland

    Site Not Available

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    Mielec, 39-300
    Poland

    Site Not Available

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    Naleczow, 24-140
    Poland

    Site Not Available

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    Nowy Sacz, 33-300
    Poland

    Site Not Available

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    Nowy Targ, 34-400
    Poland

    Site Not Available

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    Nysa, 48-300
    Poland

    Site Not Available

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    Ostrowiec Swietokrzyski, 27-400
    Poland

    Site Not Available

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    Oswiecim, 32-600
    Poland

    Site Not Available

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    Polanica-Zdroj, 57-320
    Poland

    Site Not Available

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    Pulawy, 24-100
    Poland

    Site Not Available

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    Radom, 26-617
    Poland

    Site Not Available

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    Sanok, 38-500
    Poland

    Site Not Available

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    Stalowa Wola, 37-450
    Poland

    Site Not Available

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    Starogard Gdanski, 82-200
    Poland

    Site Not Available

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    Tarnow, 33-100
    Poland

    Site Not Available

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    Warsaw, 04-628
    Poland

    Site Not Available

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    Wejherowo, 84-200
    Poland

    Site Not Available

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    Wroclaw, 53-114
    Poland

    Site Not Available

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    Zabrze, 41-800
    Poland

    Site Not Available

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    Braga, 4710-243
    Portugal

    Site Not Available

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    Carnaxide, 2794-006
    Portugal

    Site Not Available

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    Faro, 8000-386
    Portugal

    Site Not Available

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    Leiria, 2410-197
    Portugal

    Site Not Available

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    Bucharest, 050098
    Romania

    Site Not Available

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    Targu Mures, 540136
    Romania

    Site Not Available

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    Banska Bystrica, 97401
    Slovakia

    Site Not Available

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    Kosice, 04011
    Slovakia

    Site Not Available

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    Nitra, 94901
    Slovakia

    Site Not Available

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    Goteborg, 413 45
    Sweden

    Site Not Available

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    Orebro, 701 85
    Sweden

    Site Not Available

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    Vasteras, 721 89
    Sweden

    Site Not Available

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    Adana, 1330
    Turkey

    Site Not Available

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    Ankara, 06520
    Turkey

    Site Not Available

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    Antalya, 07070
    Turkey

    Site Not Available

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    Fatih, 34300
    Turkey

    Site Not Available

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    Isparta, 32100
    Turkey

    Site Not Available

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    Istanbul, 34303
    Turkey

    Site Not Available

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    Kayseri, 38039
    Turkey

    Site Not Available

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    Kocaeli, 41900
    Turkey

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Kucukcekmece, 34303
    Turkey

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Sisli, 34381
    Turkey

    Site Not Available

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