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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
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atherosclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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
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    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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