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Completed

NCT Number: NCT00617123

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

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).

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Accident Cerebrovascular Disorders Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vorapaxar 2.5 mg

Drug

Vorapaxar 2.5 mg oral tablet

Placebo

Drug

matching placebo oral tablet

Primary outcomes

  1. 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

    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 outcomes

  1. 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

    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.

  2. 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

    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.

  3. Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by OCT

    Time frame: Baseline and 4, 8 and 12 months

    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.

  4. Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by Fundus Photography

    Time frame: Baseline and 4, 8 and 12 months

    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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Duke Clinical Research Institute
  • The TIMI Study Group

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 15, 2008
Registry last updated
Sep 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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