Phase 3
Completed N=258
Trial to Assess the Ocular Safety of Vorapaxar (SCH 530348) in Participants With Atherosclerosis (Study P05183)
Atherosclerosis · Ischemia · Myocardial Infarction · Cerebrovascular Accident
Source: ClinicalTrials.gov NCT00617123 ↗
Enrolled (actual)
258
Serious AEs
—
Results posted
Jul 2014
Primary outcomePrimary: Number of Participants Who Develop Vacuolization in the Inner Nuclear Layer (INL) of the Retina as Measured by Ocular Coherence Tomography (OCT) — 1; 0; 1; 0 participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Develop Vacuolization in the Inner Nuclear Layer (INL) of the Retina as Measured by Ocular Coherence Tomography (OCT) |
1; 0; 1; 0; 0; 0 | — |
| SECONDARY Number of Participants Who Have a Decrease in Visual Acuity Score of at Least Seven Letters From Baseline |
10; 8; 10; 8; 7; 9 | — |
| SECONDARY Number of Participants With Change From Baseline of Center Foveal Thickness of Greater Than 15 Microns as Measured by OCT |
27; 28; 23; 26; 19; 29 | — |
| SECONDARY Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by OCT |
3.1; 3.4; 0.2; 0.7; 0.6; 0.9 | — |
| SECONDARY Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by Fundus Photography |
4.1; 3.9; -0.2; -0.4; -0.4; -0.6 | — |
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
Data sourced from ClinicalTrials.gov (NCT00617123). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.