Trial to Assess the Ocular Safety of Vorapaxar (SCH 530348) in Participants With Atherosclerosis (Study P05183)

This study has been completed.
Sponsor:
Collaborators:
The TIMI (Thrombolysis in Myocardial Infarction) Study Group
Duke Clinical Research Institute
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00617123
First received: February 4, 2008
Last updated: July 11, 2014
Last verified: July 2014
Results First Received: May 9, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Atherosclerosis
Ischemia
Myocardial Infarction
Cerebrovascular Accident
Interventions: Drug: Vorapaxar 2.5 mg
Drug: Placebo

  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
Participants were recruited from participants enrolled in Study SCH 530348 P04737 (NCT00526474) and met the inclusion/exclusion criteria for this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 258 particpants were referred to opthalmology sites, 65 of whom did not particpate in this study (P05138) beyond the screening visit and were not included in the analysis of ocular safety. A total of 193 participants were included in the analysis of ocular safety.

Reporting Groups
  Description
Vorapaxar Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
Placebo Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year

Participant Flow for 2 periods

Period 1:   Referral Screening Period
    Vorapaxar     Placebo  
STARTED     137     121  
COMPLETED     98     95  
NOT COMPLETED     39     26  
Did Not Meet Protocol Eligibility                 36                 24  
Did Not Wish To Continue                 3                 1  
Adverse Event                 0                 1  

Period 2:   Study Treatment Period
    Vorapaxar     Placebo  
STARTED     98     95  
Treated     97 [1]   95  
COMPLETED     81     79  
NOT COMPLETED     17     16  
Withdrawal by Subject                 8                 12  
Adverse Event                 7                 3  
Did Not Meet Protocol Eligibility                 2                 0  
Noncompliance with Protocol                 0                 1  
[1] 1 participant was not treated



  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.
Participants who were included in the analysis of ocular safety.

Reporting Groups
  Description
Vorapaxar Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
Placebo Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
Total Total of all reporting groups

Baseline Measures
    Vorapaxar     Placebo     Total  
Number of Participants  
[units: participants]
  98     95     193  
Age  
[units: years]
Mean ± Standard Deviation
  56.6  ± 10.1     55.3  ± 11.7     55.9  ± 10.9  
Gender  
[units: participants]
     
Female     27     26     53  
Male     71     69     140  



  Outcome Measures
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1.  Primary:   Number of Participants Who Develop Vacuolization in the Inner Nuclear Layer (INL) of the Retina as Measured by Ocular Coherence Tomography (OCT)   [ Time Frame: Up to 12 months ]

2.  Secondary:   Number of Participants Who Have a Decrease in Visual Acuity Score of at Least Seven Letters From Baseline   [ Time Frame: Baseline and 4, 8 and 12 months ]

3.  Secondary:   Number of Participants With Change From Baseline of Center Foveal Thickness of Greater Than 15 Microns as Measured by OCT   [ Time Frame: Baseline and 4, 8 and 12 months ]

4.  Secondary:   Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by OCT   [ Time Frame: Baseline and 4, 8 and 12 months ]

5.  Secondary:   Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by Fundus Photography   [ Time Frame: Baseline and 4, 8 and 12 months ]


  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 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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00617123     History of Changes
Other Study ID Numbers: P05183, MK-5348-018
Study First Received: February 4, 2008
Results First Received: May 9, 2014
Last Updated: July 11, 2014
Health Authority: United States: Food and Drug Administration