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

Completed

Phase 3 Results

Trial Description

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).

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: matching placebo oral tablet
    ARM 1: Kind: Experimental
    Label: Placebo
  • SCH 530348 Drug
    Intervention Desc: 2.5-mg tablet daily for at least 1 year
    ARM 1: Kind: Experimental
    Label: SCH 530348
  • Vorapaxar 2.5 mg Drug
    Intervention Desc: Vorapaxar 2.5 mg oral tablet
    ARM 1: Kind: Experimental
    Label: Vorapaxar
    Description: Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Safety Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Incidence of vacuolization in the INL of the retina through treatment and follow-up. Vacuolization is defined as the presence of more than one vacuole compared to baseline and will be evaluated by ocular coherence tomography (OCT). Through the end of study Yes
Secondary Decrease in visual acuity score of at least seven letters from baseline. All visual acuity testing will follow a standardized refraction. Through the end of study Yes
Primary Number of Participants Who Develop Vacuolization in the Inner Nuclear Layer (INL) of the Retina as Measured by Ocular Coherence Tomography (OCT) Up to 12 months Yes
Secondary Number of Participants Who Have a Decrease in Visual Acuity Score of at Least Seven Letters From Baseline Baseline and 4, 8 and 12 months Yes
Secondary Number of Participants With Change From Baseline of Center Foveal Thickness of Greater Than 15 Microns as Measured by OCT Baseline and 4, 8 and 12 months Yes
Secondary Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by OCT Baseline and 4, 8 and 12 months Yes
Secondary Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by Fundus Photography Baseline and 4, 8 and 12 months Yes

Sponsors