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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.
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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 
Overall Participants Analyzed 
[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) 
[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).
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) [1] 
[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) 
[1] BMI is an estimate of body fat based on body weight divided by height squared.
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 


  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



Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00830960     History of Changes
Other Study ID Numbers: 11299
H7T-MC-TACE ( Other Identifier: Eli Lilly and Company )
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