Trial to Assess the Ocular Safety of Vorapaxar (SCH 530348) in Participants With Atherosclerosis (Study P05183)
Primary Purpose
Atherosclerosis, Ischemia, Myocardial Infarction
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Vorapaxar 2.5 mg
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Atherosclerosis
Eligibility Criteria
Inclusion Criteria:
- Evidence or a history of atherosclerosis involving the coronary, cerebral, or peripheral vascular systems
Exclusion Criteria:
The study will include participants who meet none of the exclusion criteria for the parent protocol (P04737) and also the following:
- history or evidence of age-related macular degeneration on baseline evaluation
- history of diabetic macular edema, or evidence of treated diabetic retinopathy on baseline evaluation
- history or evidence of other retinal diseases, including retinal injury, on baseline evaluation
- history or evidence of retinal surgery, including laser photocoagulation, on baseline evaluation
- history or evidence of glaucoma on baseline evaluation
- history or evidence of high intraocular pressure of >22 mm Hg on baseline evaluation
- evidence of center foveal thickness of >190 µm on baseline OCT examination
- presence of vacuoles in the retina on baseline OCT
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vorapaxar
Placebo
Arm 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
Outcomes
Primary Outcome Measures
Number of Participants Who Develop Vacuolization in the Inner Nuclear Layer (INL) of the Retina as Measured by Ocular Coherence Tomography (OCT)
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).
Secondary Outcome Measures
Number of Participants Who Have a Decrease in Visual Acuity Score of at Least Seven Letters From Baseline
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.
Number of Participants With Change From Baseline of Center Foveal Thickness of Greater Than 15 Microns as Measured by OCT
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.
Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by OCT
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.
Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by Fundus Photography
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.
Full Information
NCT ID
NCT00617123
First Posted
February 4, 2008
Last Updated
August 22, 2018
Sponsor
Merck Sharp & Dohme LLC
Collaborators
The TIMI (Thrombolysis in Myocardial Infarction) Study Group, Duke Clinical Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00617123
Brief Title
Trial to Assess the Ocular Safety of Vorapaxar (SCH 530348) in Participants With Atherosclerosis (Study P05183)
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Ocular Safety of SCH 530348 in Subjects Participating in the Schering-Plough P04737 Study (TRA^SM-Secondary Prevention Ocular Safety Study)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2008 (Actual)
Primary Completion Date
October 1, 2010 (Actual)
Study Completion Date
October 1, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
Collaborators
The TIMI (Thrombolysis in Myocardial Infarction) Study Group, Duke Clinical Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is designed to evaluate the long-term ocular safety of SCH 530348 (vorapaxar) in participants with established atherosclerotic disease who are enrolled into the TRA 2°P - TIMI 50 Study (P04737) (NCT00526474).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Ischemia, Myocardial Infarction, Cerebrovascular Accident
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
258 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vorapaxar
Arm Type
Experimental
Arm Description
Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
Intervention Type
Drug
Intervention Name(s)
Vorapaxar 2.5 mg
Intervention Description
Vorapaxar 2.5 mg oral tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
matching placebo oral tablet
Primary Outcome Measure Information:
Title
Number of Participants Who Develop Vacuolization in the Inner Nuclear Layer (INL) of the Retina as Measured by Ocular Coherence Tomography (OCT)
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
Secondary Outcome Measure Information:
Title
Number of Participants Who Have a Decrease in Visual Acuity Score of at Least Seven Letters From Baseline
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
Title
Number of Participants With Change From Baseline of Center Foveal Thickness of Greater Than 15 Microns as Measured by OCT
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
Title
Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by OCT
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
Title
Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by Fundus Photography
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Evidence or a history of atherosclerosis involving the coronary, cerebral, or peripheral vascular systems
Exclusion Criteria:
The study will include participants who meet none of the exclusion criteria for the parent protocol (P04737) and also the following:
history or evidence of age-related macular degeneration on baseline evaluation
history of diabetic macular edema, or evidence of treated diabetic retinopathy on baseline evaluation
history or evidence of other retinal diseases, including retinal injury, on baseline evaluation
history or evidence of retinal surgery, including laser photocoagulation, on baseline evaluation
history or evidence of glaucoma on baseline evaluation
history or evidence of high intraocular pressure of >22 mm Hg on baseline evaluation
evidence of center foveal thickness of >190 µm on baseline OCT examination
presence of vacuoles in the retina on baseline OCT
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/study.html?id=P05183&kw=P05183&tab=access
Learn more about this trial
Trial to Assess the Ocular Safety of Vorapaxar (SCH 530348) in Participants With Atherosclerosis (Study P05183)
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