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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-01

Study Completion Date

2010-10-01

Brief Summary

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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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Detailed Description

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Conditions

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Atherosclerosis Ischemia Myocardial Infarction Cerebrovascular Accident

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Vorapaxar

Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year

Group Type EXPERIMENTAL

Vorapaxar 2.5 mg

Intervention Type DRUG

Vorapaxar 2.5 mg oral tablet

Placebo

Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

matching placebo oral tablet

Interventions

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Vorapaxar 2.5 mg

Vorapaxar 2.5 mg oral tablet

Intervention Type DRUG

Placebo

matching placebo oral tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Evidence or a history of atherosclerosis involving the coronary, cerebral, or peripheral vascular systems

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No