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

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ClinicalTrials.gov Identifier: NCT00617123
Recruitment Status : Completed
First Posted : February 15, 2008
Results First Posted : July 14, 2014
Last Update Posted : September 21, 2018
Sponsor:
Collaborators:
The TIMI (Thrombolysis in Myocardial Infarction) Study Group
Duke Clinical Research Institute
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Atherosclerosis
Ischemia
Myocardial Infarction
Cerebrovascular Accident
Interventions Drug: Vorapaxar 2.5 mg
Drug: Placebo
Enrollment 258
Recruitment Details Participants were recruited from participants enrolled in Study SCH 530348 P04737 (NCT00526474) and met the inclusion/exclusion criteria for this study.
Pre-assignment Details 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.
Arm/Group Title Vorapaxar Placebo
Hide Arm/Group Description Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
Period Title: Referral Screening Period
Started 137 121
Completed 98 95
Not Completed 39 26
Reason Not Completed
Did Not Meet Protocol Eligibility             36             24
Did Not Wish To Continue             3             1
Adverse Event             0             1
Period Title: Study Treatment Period
Started 98 95
Treated 97 [1] 95
Completed 81 79
Not Completed 17 16
Reason Not Completed
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
Arm/Group Title Vorapaxar Placebo Total
Hide Arm/Group Description Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year Total of all reporting groups
Overall Number of Baseline Participants 98 95 193
Hide Baseline Analysis Population Description
Participants who were included in the analysis of ocular safety.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 98 participants 95 participants 193 participants
56.6  (10.1) 55.3  (11.7) 55.9  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 95 participants 193 participants
Female
27
  27.6%
26
  27.4%
53
  27.5%
Male
71
  72.4%
69
  72.6%
140
  72.5%
1.Primary Outcome
Title Number of Participants Who Develop Vacuolization in the Inner Nuclear Layer (INL) of the Retina as Measured by Ocular Coherence Tomography (OCT)
Hide Description Vacuolization is defined as the presence of more than one vacuole (defined as a clear, round structure in the INL of the retina of at least 30 microns in diameter) compared to baseline in either the left or right eye as evaluated by ocular coherence tomography (OCT).
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who took at least one dose of study medication, and had a baseline and at least one post-baseline vacuolation assessment.
Arm/Group Title Vorapaxar Placebo
Hide Arm/Group Description:
Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
Overall Number of Participants Analyzed 91 86
Measure Type: Number
Unit of Measure: participants
4 months (n=91, n=86) 1 0
8 months (n=86, n=80) 1 0
12 months (n=77, n=78) 0 0
2.Secondary Outcome
Title Number of Participants Who Have a Decrease in Visual Acuity Score of at Least Seven Letters From Baseline
Hide Description Visual acuity was assessed in both eyes by best corrected visual acuity following standardized refraction. The best corrected visual acuity score is the number of letters on a standard visual acuity testing chart read correctly by a participant. A decrease in best corrected visual acuity score in the left and/or right eye indicates a worsening of vision.
Time Frame Baseline and 4, 8 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who took at least one dose of study medication, and had a baseline and at least one post-baseline visual acuity score.
Arm/Group Title Vorapaxar Placebo
Hide Arm/Group Description:
Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
Overall Number of Participants Analyzed 90 86
Measure Type: Number
Unit of Measure: participants
4 months (n=90, n=86) 10 8
8 months (n=86, n=80) 10 8
12 months (n=78, n=78) 7 9
3.Secondary Outcome
Title Number of Participants With Change From Baseline of Center Foveal Thickness of Greater Than 15 Microns as Measured by OCT
Hide Description Center foveal thickness measured by OCT was evaluated for a change from baseline in greater than 15 microns in either the left or right eye.
Time Frame Baseline and 4, 8 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who took at least one dose of study medication, and had a baseline and at least one post-baseline center point thickness assessment by OCT.
Arm/Group Title Vorapaxar Placebo
Hide Arm/Group Description:
Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
Overall Number of Participants Analyzed 91 86
Measure Type: Number
Unit of Measure: participants
4 months (n=91, n=86) 27 28
8 months (n=86, n=80) 23 26
12 months (n=77, n=78) 19 29
4.Secondary Outcome
Title Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by OCT
Hide Description Individual OCT abnormalities were scored as 0=not present or 1=present. The total number of possible abnormalities present was 84 (42 possible abnormalities per eye). Data are for the left and right eyes combined (score range: 0 to 84). Change from Baseline at a given timepoint was calculated as Timepoint Score minus Baseline Score. A smaller score indicates fewer graded abnormalities.
Time Frame Baseline and 4, 8 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who took at least one dose of study medication, and had a baseline and at least one post-baseline numerical score of graded abnormalities assessment by OCT.
Arm/Group Title Vorapaxar Placebo
Hide Arm/Group Description:
Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
Overall Number of Participants Analyzed 92 87
Mean (Standard Error)
Unit of Measure: score on a scale
Baseline score (n=92, n=87) 3.1  (0.3) 3.4  (0.4)
4 months change (n=91, n=86) 0.2  (0.3) 0.7  (0.3)
8 months change (n=86, n=80) 0.6  (0.3) 0.9  (0.3)
12 months change (n=77, n=78) 0.2  (0.3) 0.0  (0.3)
5.Secondary Outcome
Title Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by Fundus Photography
Hide Description Individual fundus photography abnormalities were scored as 0=not present or 1=present. The total number of possible abnormalities present was 48 (24 possible abnomalities per eye). Data are for the left and right eyes combined (score range: 0 to 48). Change from Baseline at a given timepoint was calculated as Timepoint Score minus Baseline Score. A smaller score indicates fewer graded abnormalities.
Time Frame Baseline and 4, 8 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who took at least one dose of study medication, and had a baseline and at least one post-baseline numerical score of graded abnormalities assessment as measured by fundus photogrpahy.
Arm/Group Title Vorapaxar Placebo
Hide Arm/Group Description:
Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
Overall Number of Participants Analyzed 91 87
Mean (Standard Error)
Unit of Measure: score on a scale
Baseline score (n=91, n=87) 4.1  (0.4) 3.9  (0.4)
4 months change (n=90, n=86) -0.2  (0.4) -0.4  (0.3)
8 months change (n=86, n=80) -0.4  (0.4) -0.6  (0.4)
12 months change (n=76, n=77) -0.6  (0.5) -0.3  (0.5)
Time Frame [Not Specified]
Adverse Event Reporting Description Participant safety data collected on the eCRF for this study (SCH 530348 P05183) were limited to ocular test results. These ocular test results were not captured as adverse events, but were captured as part of outcome measures. All other participant adverse events were collected under the Study SCH 530348 P04737 (NCT00526474) parent protocol.
 
Arm/Group Title Vorapaxar Placebo
Hide Arm/Group Description Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
All-Cause Mortality
Vorapaxar Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Vorapaxar Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vorapaxar Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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 investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00617123    
Other Study ID Numbers: P05183
MK-5348-018 ( Other Identifier: Merck Protocol Number )
First Submitted: February 4, 2008
First Posted: February 15, 2008
Results First Submitted: May 9, 2014
Results First Posted: July 14, 2014
Last Update Posted: September 21, 2018