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Pharmacodynamic Evaluation of Switching From Ticagrelor to Prasugrel in Subjects With Stable Coronary Artery Disease (SWAP-2)

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT01587651
First received: April 26, 2012
Last updated: March 26, 2014
Last verified: March 2014
Results First Received: February 11, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Coronary Artery Disease
Interventions: Drug: Prasugrel Loading Dose
Drug: Prasugrel Maintenance Dose
Drug: Ticagrelor Maintenance Dose

  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
All subjects must have been taking low dose aspirin (ASA) (75 mg to 150 mg once daily-QD) for at least 7 days prior to Screening (Visit 1), and must have continued the same regimen throughout the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study consisted of a 3 to 5 day ticagrelor run-in phase followed by randomized treatment on 1 of 2 prasugrel regimens or continued ticagrelor

Reporting Groups
  Description
Prasugrel Loading Dose

Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD)

Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet

Prasugrel Loading Dose : 60mg given as six 10mg film coated tablets

Prasugrel Maintenance Dose

Prasugrel 10 mg QD MD

Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet

Ticagrelor Maintenance Dose

Ticagrelor 90 mg twice-daily (BID) MD

Ticagrelor Maintenance Dose : one 90mg film coated tablet


Participant Flow:   Overall Study
    Prasugrel Loading Dose     Prasugrel Maintenance Dose     Ticagrelor Maintenance Dose  
STARTED     34     41     35  
COMPLETED     34     38     34  
NOT COMPLETED     0     3     1  
Adverse Event                 0                 1                 0  
Protocol Violation                 0                 1                 1  
Withdrawal by Subject                 0                 1                 0  



  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 Loading Dose

Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD)

Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet

Prasugrel Loading Dose : 60mg given as six 10mg film coated tablets

Prasugrel Maintenance Dose

Prasugrel 10 mg QD MD

Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet

Ticagrelor Maintenance Dose

Ticagrelor 90 mg twice-daily (BID) MD

Ticagrelor Maintenance Dose : one 90mg film coated tablet

Total Total of all reporting groups

Baseline Measures
    Prasugrel Loading Dose     Prasugrel Maintenance Dose     Ticagrelor Maintenance Dose     Total  
Number of Participants  
[units: participants]
  34     41     35     110  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     24     28     22     74  
>=65 years     10     13     13     36  
Age  
[units: years]
Mean ± Standard Deviation
  57.8  ± 9.69     58.5  ± 8.84     61.5  ± 6.87     59.2  ± 8.62  
Gender  
[units: participants]
       
Female     10     11     8     29  
Male     24     30     27     81  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     1     3     4     8  
Not Hispanic or Latino     33     36     30     99  
Unknown or Not Reported     0     2     1     3  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     1     0     0     1  
Asian     0     1     0     1  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     7     7     4     18  
White     26     33     30     89  
More than one race     0     0     1     1  
Unknown or Not Reported     0     0     0     0  
Region of Enrollment  
[units: participants]
       
United States     30     36     32     98  
United Kingdom     4     5     3     12  
weight  
[units: kg]
Mean ± Standard Deviation
  97.0  ± 17.70     95.4  ± 18.85     89.4  ± 19.35     94.0  ± 18.77  
height  
[units: cm]
Mean ± Standard Deviation
  171.2  ± 8.74     171.9  ± 10.15     174.3  ± 9.14     172.4  ± 9.41  
body mass index  
[units: kg/m^2]
Mean ± Standard Deviation
  33.2  ± 5.88     32.3  ± 5.92     29.2  ± 4.82     31.6  ± 5.77  
diabetes mellitus history [1]
[units: participants]
  14     12     5     31  
hypertension history [2]
[units: participants]
  26     29     24     79  
hyperlipidemia history [3]
[units: participants]
  32     35     31     98  
peripheral artery disease history [4]
[units: participants]
  2     1     2     5  
body mass index category [5]
[units: participants]
       
< 30 kg/m^2     13     16     24     53  
>= 30 kg/m^2     21     24     11     56  
Unknown     0     1     0     1  
[1] number of participants with diabetes mellitus sum of categories does not equal number of participants due to not all participants having this specific medical condition
[2] number of participants with hypertension susum of categories does not equal number of participants due to not all participants having this specific medical condition
[3] number of participants with hyperlipidemia sum of categories does not equal number of participants due to not all participants having this specific medical condition
[4] number of participants with peripheral artery disease (PAD) sum of categories does not equal number of participants due to not all participants having this specific medical condition
[5] body mass index <30 kg/m^2 or >= 30 kg/m^2 sum of categories does not equal number of participants due to missing data for 1 subject



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   P2Y12 Reaction Units   [ Time Frame: 7 days after first randomized dose ]

2.  Secondary:   P2Y12 Reaction Units   [ Time Frame: 2, 4, 24, 48 hours after first randomized dose ]

3.  Secondary:   Platelet Reactivity Index   [ Time Frame: 2, 4, 24, 48 hours, 7 days after first randomized dose ]

4.  Secondary:   PRU Percent Inhibition (Device-reported)   [ Time Frame: 2, 4, 24, 48 hours, 7 days after first randomized dose ]

5.  Secondary:   PRU Percent Inhibition (Calculated)   [ Time Frame: 2, 4, 24, 48 hours, 7 days after first randomized dose ]

6.  Secondary:   Percentage of Subjects With High On-treatment Platelet Reactivity   [ Time Frame: 2, 4, 24, 48 hours, 7 days after first randomized dose ]


  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
No text entered.


  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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Fred Lipkin
Organization: Daiichi Sankyo Medical Affairs
phone: 973-944-2216
e-mail: flipkin@dsi.com


No publications provided


Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT01587651     History of Changes
Other Study ID Numbers: CS747s-B-U4003
Study First Received: April 26, 2012
Results First Received: February 11, 2014
Last Updated: March 26, 2014
Health Authority: United States: Food and Drug Administration