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A Comparison of Antiplatelet Therapies in Asian Subjects With Acute Coronary Syndrome

22 septembre 2011 mis à jour par: Eli Lilly and Company

A Comparison of Platelet Inhibition Following Prasugrel or Clopidogrel Administration in Asian Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention

The study will compare the safety and efficacy of prasugrel, administered at different doses with clopidogrel in the treatment of Asian participants with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

720

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Chine
      • Beijing, Chine, 100853
        • 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.
      • Guang Zhou, Chine, 510080
        • 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.
      • Hangzhou, Chine, 310009
        • 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.
      • Nanjing, Chine, 210008
        • 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.
      • Shanghai, Chine, 200433
        • 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.
      • Shenyang, Chine, 110016
        • 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.
      • Wenzhou, Chine, 325027
        • 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.
      • Xi'An, Chine, 710061
        • 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.
  • Corée, République de
      • Daegu, Corée, République de, 700-721
        • 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.
      • Kwang Ju, Corée, République de, 501-757
        • 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.
      • Seongnam-Si, Corée, République de, 463-707
        • 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.
      • Seoul, Corée, République de, 135 720
        • 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.
      • Suwon-City, Corée, République de, 442-721
        • 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.
  • Taïwan
      • Taichung, Taïwan, 404
        • 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.
      • Taichung City, Taïwan, 40201
        • 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.
      • Taipei, Taïwan, 112
        • 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.
      • Tao-Yuan, Taïwan, 333
        • 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.
  • Thaïlande
      • Bangkok, Thaïlande, 10400
        • 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.
      • Chiang Mai, Thaïlande, 50200
        • 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.

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • A person who has been diagnosed with acute coronary syndrome (ACS) and is to undergo a percutaneous coronary intervention (PCI)
  • A person who is of East or Southeast Asian descent
  • A person who is of the legal age of 18 (or age 21 in Singapore) and is mentally competent to provide a signed written informed consent before entering the study
  • If a woman is of childbearing potential, she must test negative for pregnancy and agree to use a reliable method of birth control

Exclusion Criteria:

  • A person who has a severe cardiovascular condition such as cardiogenic shock at the time of randomization, ventricular arrhythmias or congestive heart failure
  • A person who is at an increased risk of bleeding (e.g. active internal bleeding, history of bleeding disorder, recent fibrinolytic therapy before randomization into the study)
  • A person who has prior history of any one of the following: ischemic or hemorrhagic stroke; intracranial neoplasm, arteriovenous malformation, or aneurysm; prior history of transient ischemic attack (TIA)
  • A person who needs to take other antiplatelet therapy other than Aspirin for the duration of the study
  • A person who receives daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be discontinued
  • A person who has a severe liver disease, such as cirrhosis
  • A person who has a condition such as alcoholism, mental illness, or drug dependence

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Prasugrel 60/10 Primary
Loading dose 60 mg followed by maintenance dose 10 mg/day
Médicament: Prasugrel
Oral, daily, 90 days
Autres noms:
  • Efficace
  • LY640315
  • CS-747
  • Éfient
Expérimental: Prasugrel 30/7.5 Primary
Loading dose 30 mg followed by maintenance dose 7.5 mg/day
Médicament: Prasugrel
Oral, daily, 90 days
Autres noms:
  • Efficace
  • LY640315
  • CS-747
  • Éfient
Expérimental: Prasugrel 30/5 Primary
Loading dose 30 mg followed by maintenance dose 5 mg/day
Médicament: Prasugrel
Oral, daily, 90 days
Autres noms:
  • Efficace
  • LY640315
  • CS-747
  • Éfient
Comparateur actif: Clopidogrel 300/75 Primary
Loading dose 300 mg followed by maintenance dose 75 mg/day
Médicament: Clopidogrel
Oral, daily, 90 days
Autres noms:
  • Plavix
Expérimental: Prasugrel 30/5 Low Weight/Elderly
Loading dose 30 mg followed by maintenance dose 5 mg/day
Médicament: Prasugrel
Oral, daily, 90 days
Autres noms:
  • Efficace
  • LY640315
  • CS-747
  • Éfient
Comparateur actif: Clopidogrel 300/75 Low Weight/Elderly
Loading dose 300 mg followed by maintenance dose 75 mg/day
Médicament: Clopidogrel
Oral, daily, 90 days
Autres noms:
  • Plavix

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation (P2Y12 Reaction Units; PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 4 Hours Post-Loading Dose (LD) in Primary Cohort (≥60 kg and <75 Years)
Délai: At 4 hours following LD administration

ADP-induced PRU represents the rate and extent of ADP-stimulated platelet aggregation and serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition.

Observed PRU values are presented with statistical comparisons of difference in least squares mean (LS mean) PRU values between prasugrel and clopidogrel.

Efficacy analyses are analyzed and presented separately for the LD and maintenance dose (MD) phase.
At 4 hours following LD administration
Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Days During Maintenance Dose (MD) Administration in Primary Cohort
Délai: At 30 days during MD therapy

Efficacy analyses are analyzed and presented separately for the loading dose (LD) and MD phase. This primary outcome analysis compares PRU for the 3 prasugrel MDs (10 mg, 7.5 mg, and 5 mg) with the clopidogrel 75-mg MD at 30 days post-MD in the primary cohort (participants who weighed ≥60 kg and were <75 years).

ADP-induced PRU serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition.

Observed PRU values are presented with statistical comparisons of LS mean difference between prasugrel and clopidogrel.
At 30 days during MD therapy

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Minutes, 2 and 4 Hours Post-Loading Dose (LD) in Primary (≥60 kg and <75 Years) and Low Weight/Elderly (<60 kg or ≥75 Years) Cohorts.
Délai: At 30 minutes, 2 hours, and 4 hours following LD administration

Efficacy analyses analyzed and presented separately for LD and maintenance dose (MD) phase. Analysis compares PRU for prasugrel LDs (30 mg and 60 mg) with clopidogrel 300-mg LD at 30 minutes post-LD.

Data for Primary Cohort at 4 hours post-LD, already presented in first Primary Outcome Measure, are also presented here.

ADP-induced PRU serves as biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition.

Observed PRU values presented with statistical comparisons of least-squares mean (LS mean) difference between prasugrel and clopidogrel.
At 30 minutes, 2 hours, and 4 hours following LD administration
Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at During Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort
Délai: At 30 Days and 90 days during MD therapy

Efficacy analyses analyzed and presented separately for loading dose (LD) and MD phase. Analysis compares PRU for 3 prasugrel MDs (10 mg, 7.5 mg, and 5 mg) with clopidogrel 75-mg MD at 30 days post-MD.

Data for Primary Cohort at 30 days post-LD, already presented in second Primary Outcome Measure, are also presented here.

ADP-induced PRU serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition.

Observed PRU values are presented with statistical comparisons of least squares (LS) mean difference between prasugrel and clopidogrel.
At 30 Days and 90 days during MD therapy
Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) at 30 Minutes, 2 Hours, and 4 Hours Post-Loading Dose (LD) in Primary in Primary Cohort and Low Weight/Elderly Cohort
Délai: 30 minutes, 2 hours, and 4 hours following LD administration
A higher percentage (percent inhibition least squares mean [LS mean]) represents greater platelet inhibition.
30 minutes, 2 hours, and 4 hours following LD administration
Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) During the Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort
Délai: 30 days and at 90 days during MD therapy
A higher percentage (percent inhibition least squares mean [LS mean]) represents greater platelet inhibition.
30 days and at 90 days during MD therapy
Summary of Myocardial Infarction (MI), Stroke, Stent Thrombosis and Urgent Target Vessel Revascularization (UTVR) in Primary Cohort and Low Weight/Elderly Cohort
Délai: Randomization through end of study (90 days)

Nonfatal MI: American College of Cardiology (ACC) definition Nonfatal stroke: rapid onset of new, persistent neurologic deficit lasting >24 hours; classified as either ischemic or hemorrhagic based on imaging data, if available, or uncertain cause if imaging data was not available.

Stent thrombosis: defined as definite, probable, or possible, based on Academic Research Consortium definitions.

UTVR: percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) for recurrent ischemia. Revascularization must have included the vessel(s) dilated at the initial procedure
Randomization through end of study (90 days)
Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Non-fatal Stroke
Délai: 30 days and 90 days

Risk was defined as the number of participants with events of CV death, nonfatal MI, or nonfatal stroke.

CV death: death caused by CV event or not clearly attributable to non-CV causes.

Nonfatal MI: per adapted American College of Cardiology definition.

Nonfatal stroke: rapid onset of new, persistent neurologic deficit lasting more than 24 hours; either ischemic or hemorrhagic based on imaging data, if available, or uncertain cause if imaging data was not available.

As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed.
30 days and 90 days
Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Urgent Target Vessel Revascularization (UTVR)
Délai: 30 days and 90 days

Risk was defined as the number of participants with events of CV death, nonfatal MI, or UTVR.

UTVR: percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) for recurrent ischemia. Revascularization must have included the vessel(s) dilated at the initial procedure.

As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed.
30 days and 90 days
Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Recurrent Myocardial Ischemia Requiring Hospitalization
Délai: 30 days and 90 days

Risk was defined as the number of events of CV death, nonfatal MI, nonfatal stroke or recurrent myocardial ischemia requiring hospitalization.

Recurrent myocardial ischemia requiring hospitalization: rehospitalization for symptoms of myocardial ischemia at rest with either new ST-segment deviation ≥1 mm, or performance of a coronary revascularization procedure percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) during the same hospital stay.

As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed.
30 days and 90 days
Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Urgent Target Vessel Revascularization (UTVR), or Recurrent Myocardial Ischemia Requiring Hospitalization (Analyzed Individually)
Délai: 30 days and 90 days
Risk was defined as the number of participants with events of CV death, nonfatal MI, nonfatal stroke, UTVR, or recurrent myocardial ischemia requiring hospitalization.
30 days and 90 days
Risk of Definite or Probable Stent Thrombosis Per ARC (Academic Research Consortium) Definition
Délai: 30 days and 90 days

Risk was defined as the number of participants with events of definite or probable stent thrombosis.

As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed.
30 days and 90 days
Risk of Definite, Probable, or Possible Stent Thrombosis Per Academic Research Consortium (ARC) Definition
Délai: 90 days

Risk was defined as the number of participants with events of definite, probable, or possible stent thrombosis.

As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed.
90 days
Risk of All-cause Death in Primary Cohort and Low Weight/Elderly Cohort
Délai: Randomization through end of study (90 days)
Risk was defined as the number of participants with events of all-cause death.
Randomization through end of study (90 days)
Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding
Délai: Randomization through end of study (90 days)

Bleeding events were classified and analyzed in accordance with the TIMI criteria definitions.

Major bleeding: any intracranial hemorrhage (ICR) OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 grams/deciliter (gm/dL) from baseline.

Minor bleeding: any clinically overt bleeding associated with a fall in Hgb of ≥3 but <5 gm/dL from baseline.

Insignificant bleeding: any bleeding event that does not meet criteria for a Major or Minor bleed.
Randomization through end of study (90 days)
Incidence of CABG-related TIMI Major or Minor Bleeding.
Délai: Randomization through end of study (90 days)
Randomization through end of study (90 days)
Inpatient Healthcare Resource Utilization
Délai: Initial hospitalization, 30 days, 90 days
Healthcare resource utilization data were modeled from historical analyses to determine initial hospitalization costs, total 30-day medical care costs, and total 90-day medical care costs.
Initial hospitalization, 30 days, 90 days
Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary
Délai: Baseline to 4 hours post-loading dose (LD), 30 days and 90 days during maintenance dose (MD) phase

The primary hypothesis for the genetics substudy was that CYP2C19 genetic variation has a significant effect on pharmacodynamic (PD) response to clopidogrel but not on PD response to prasugrel per change in PRU as measured by the Accumetrics VerifyNow P2Y12 device.

Participants were classified by CYP2C19 genotype into predicted metabolic phenotypes according to literature-based functional predictions. These classifications were clustered into 2 groups: extensive metabolizer (EM) and reduced metabolizer (RM).

A higher value for change in PRU indicates a greater level of platelet inhibition.
Baseline to 4 hours post-loading dose (LD), 30 days and 90 days during maintenance dose (MD) phase
Risk of CV Death, Nonfatal MI, Nonfatal Stroke, UTVR, or Recurrent Myocardial Ischemia Requiring Hospitalization (Analyzed Individually)
Délai: 30 days and 90 days
Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Urgent Target Vessel Revascularization (UTVR), or Recurrent Myocardial Ischemia Requiring Hospitalization (Analyzed Individually)
30 days and 90 days

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Eli Lilly and Company

Collaborateurs

Daiichi Sankyo Co., Ltd.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 février 2009

Achèvement primaire (Réel)

1 juin 2010

Achèvement de l'étude (Réel)

1 juin 2010

Dates d'inscription aux études

Première soumission

27 janvier 2009

Première soumission répondant aux critères de contrôle qualité

27 janvier 2009

Première publication (Estimation)

28 janvier 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

2 novembre 2011

Dernière mise à jour soumise répondant aux critères de contrôle qualité

22 septembre 2011

Dernière vérification

1 septembre 2011

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 11299 (DAIDS ES Registry Number)
  • H7T-MC-TACE (Autre identifiant: Eli Lilly and Company)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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