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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Cerebrovascular Accident; Ischemia; Myocardial Infarction; Atherosclerosis

Treatments: Drug: Placebo; Drug: Vorapaxar 2.5 mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00617123

P05183

MK-5348-018 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 258 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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258 participants in 2 patient groups, including a placebo group

Vorapaxar

Experimental group

Description:

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

Treatment:

Drug: Vorapaxar 2.5 mg

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo