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

This study has been completed.
Sponsor:
Collaborator:
Daiichi Sankyo Co., Ltd.
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00830960
First received: January 27, 2009
Last updated: September 22, 2011
Last verified: September 2011
Results First Received: June 17, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Acute Coronary Syndrome
Interventions: Drug: Prasugrel
Drug: Clopidogrel

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study had 4 treatment arms and had 2 cohorts; a Primary Cohort (≥60 kilograms [kg] and age <75 years) and a Low Weight/Elderly cohort (<60 kg or age ≥75 years). Randomization was stratified by country, cohort and anticipated glycoprotein (GP) IIb/IIIa inhibitor use.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

One participant who was enrolled based on weight >60 kg was not assigned to primary cohort due to no weight entered in case report form.

Low Weight/Elderly Cohort was only assigned to prasugrel 30-mg loading dose (LD)/5-mg maintenance dose (MD) or clopidogrel 300-mg LD/75-mg MD due to evidence of increased bleeding risk for these populations.


Reporting Groups
  Description
Prasugrel 60/10 Primary Population includes participants randomly assigned to receive prasugrel 60-mg loading dose (LD) followed by prasugrel 10-mg maintenance dose (MD) daily in the primary cohort (participant weight ≥60 kg and age <75 years)
Prasugrel 30/7.5 Primary Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
Prasugrel 30/5 Primary Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
Clopidogrel 300/75 Primary Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
Prasugrel 30/5 Low Weight/Elderly Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
Clopidogrel 300/75 Low Weight/Elderly Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)

Participant Flow:   Overall Study
    Prasugrel 60/10 Primary     Prasugrel 30/7.5 Primary     Prasugrel 30/5 Primary     Clopidogrel 300/75 Primary     Prasugrel 30/5 Low Weight/Elderly     Clopidogrel 300/75 Low Weight/Elderly  
STARTED     124 [1]   124     137     138     96     100 [2]
Received at Least 1 Dose of Study Drug     117 [3]   122     133     135     91     93  
COMPLETED     91     96     108     106     64 [4]   63  
NOT COMPLETED     33     28     29     32     32     37  
Death                 5                 4                 3                 2                 6                 1  
Lost to Follow-up                 1                 1                 1                 0                 0                 1  
Withdrawal by Subject                 19                 19                 18                 23                 16                 21  
Sponsor Decision                 1                 2                 3                 4                 5                 7  
No study drug received                 7                 2                 4                 3                 5                 7  
[1] Number of participants "STARTED" equals the number of participants randomized.
[2] Total 720 participants were randomized; 1 was not included in a cohort as baseline weight missing.
[3] Baseline Characteristics (below) include those who received ≥1 dose study drug, not all who STARTED.
[4] 6 participants not completed due to death; 1 additional death occurred after study discontinuation.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Prasugrel 60/10 Primary

Study treatment of prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)

Reporting groups for Baseline Characteristics do not include all randomized participants (n=720), but includes all randomized participants who received at least 1 dose of study drug.

Prasugrel 30/7.5 Primary Study treatment of prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
Prasugrel 30/5 Primary Study treatment of prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
Clopidogrel 300/75 Primary Study treatment of clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
Prasugrel 30/5 Low Weight/Elderly Study treatment of prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
Clopidogrel 300/75 Low Weight/Elderly Study treatment of clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
Total Total of all reporting groups

Baseline Measures
    Prasugrel 60/10 Primary     Prasugrel 30/7.5 Primary     Prasugrel 30/5 Primary     Clopidogrel 300/75 Primary     Prasugrel 30/5 Low Weight/Elderly     Clopidogrel 300/75 Low Weight/Elderly     Total  
Number of Participants  
[units: participants]
  117     122     133     135     91     93     691  
Age [1]
[units: years]
Mean ± Standard Deviation
             
Mean Age Overall     58.3  ± 9.83     57.7  ± 9.47     57.2  ± 10.49     58.3  ± 8.95     68.5  ± 9.74     69.1  ± 12.08     60.8  ± 11.13  
Gender  
[units: participants]
             
Female     16     14     27     24     45     48     174  
Male     101     108     106     111     46     45     517  
Region of Enrollment  
[units: participants]
             
China     85     85     93     95     64     61     483  
Korea, Republic of     15     19     20     19     13     15     101  
Taiwan     12     14     15     16     10     11     78  
Thailand     5     4     5     5     4     6     29  
Body Mass Index (BMI) [2]
[units: kilograms per square meter (kg/m²)]
Mean ± Standard Deviation
             
BMI     25.86  ± 2.907     25.75  ± 2.990     26.06  ± 2.637     26.19  ± 2.999     22.02  ± 4.106     22.10  ± 3.166     24.74  ± 3.510  
Qualifying Diagnosis  
[units: participants]
             
Unstable angina (UA)     32     42     38     41     26     30     209  
Non-ST segment elevation myocardial infarction     13     16     21     17     10     10     87  
ST segment elevation myocardial infarction     72     64     74     77     55     53     395  
[1] Total mean age is based on all randomized participants who received at least 1 dose of study drug, and for whom information was available (n=689).
[2] BMI is an estimate of body fat based on body weight divided by height squared.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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)   [ Time Frame: At 4 hours following LD administration ]

2.  Primary:   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   [ Time Frame: At 30 days during MD therapy ]

3.  Secondary:   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.   [ Time Frame: At 30 minutes, 2 hours, and 4 hours following LD administration ]

4.  Secondary:   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   [ Time Frame: At 30 Days and 90 days during MD therapy ]

5.  Secondary:   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   [ Time Frame: 30 minutes, 2 hours, and 4 hours following LD administration ]

6.  Secondary:   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   [ Time Frame: 30 days and at 90 days during MD therapy ]

7.  Secondary:   Summary of Myocardial Infarction (MI), Stroke, Stent Thrombosis and Urgent Target Vessel Revascularization (UTVR) in Primary Cohort and Low Weight/Elderly Cohort   [ Time Frame: Randomization through end of study (90 days) ]

8.  Secondary:   Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Non-fatal Stroke   [ Time Frame: 30 days and 90 days ]

9.  Secondary:   Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Urgent Target Vessel Revascularization (UTVR)   [ Time Frame: 30 days and 90 days ]

10.  Secondary:   Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Recurrent Myocardial Ischemia Requiring Hospitalization   [ Time Frame: 30 days and 90 days ]

11.  Secondary:   Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Urgent Target Vessel Revascularization (UTVR), or Recurrent Myocardial Ischemia Requiring Hospitalization (Analyzed Individually)   [ Time Frame: 30 days and 90 days ]

12.  Secondary:   Risk of Definite or Probable Stent Thrombosis Per ARC (Academic Research Consortium) Definition   [ Time Frame: 30 days and 90 days ]

13.  Secondary:   Risk of Definite, Probable, or Possible Stent Thrombosis Per Academic Research Consortium (ARC) Definition   [ Time Frame: 90 days ]

14.  Secondary:   Risk of All-cause Death in Primary Cohort and Low Weight/Elderly Cohort   [ Time Frame: Randomization through end of study (90 days) ]

15.  Secondary:   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   [ Time Frame: Randomization through end of study (90 days) ]

16.  Secondary:   Incidence of CABG-related TIMI Major or Minor Bleeding.   [ Time Frame: Randomization through end of study (90 days) ]

17.  Secondary:   Inpatient Healthcare Resource Utilization   [ Time Frame: Initial hospitalization, 30 days, 90 days ]

18.  Secondary:   Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary   [ Time Frame: Baseline to 4 hours post-loading dose (LD), 30 days and 90 days during maintenance dose (MD) phase ]

19.  Secondary:   Risk of CV Death, Nonfatal MI, Nonfatal Stroke, UTVR, or Recurrent Myocardial Ischemia Requiring Hospitalization (Analyzed Individually)   [ Time Frame: 30 days and 90 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


No publications provided


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00830960     History of Changes
Other Study ID Numbers: 11299, H7T-MC-TACE
Study First Received: January 27, 2009
Results First Received: June 17, 2011
Last Updated: September 22, 2011
Health Authority: China: Food and Drug Administration
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health
Thailand: Food and Drug Administration
Singapore: Health Sciences Authority