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

• ClinicalTrials.gov Identifier: NCT00617123
• Recruitment Status: Completed
• First Posted: February 15, 2008
• Results First Posted: July 14, 2014
• Last Update Posted: September 21, 2018
• Sponsor: Merck Sharp & Dohme Corp.
• Collaborators: The TIMI (Thrombolysis in Myocardial Infarction) Study Group; Duke Clinical Research Institute
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Tracking Information

• First Submitted Date: February 4, 2008
• First Posted Date: February 15, 2008
• Results First Submitted Date: May 9, 2014
• Results First Posted Date: July 14, 2014
• Last Update Posted Date: September 21, 2018
• Actual Study Start Date: July 1, 2008
• Actual Primary Completion Date: October 1, 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 11, 2014)

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).

• Original Primary Outcome Measures (submitted: February 4, 2008): 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). [ Time Frame: Through the end of study ]

Current Secondary Outcome Measures (submitted: July 11, 2014)

• 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.
• 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.
• 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.
• 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.

• Original Secondary Outcome Measures (submitted: February 4, 2008): Decrease in visual acuity score of at least seven letters from baseline. All visual acuity testing will follow a standardized refraction. [ Time Frame: Through the end of study ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Trial to Assess the Ocular Safety of Vorapaxar (SCH 530348) in Participants With Atherosclerosis (Study P05183)
• Official 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)
• Brief 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Prevention

Condition

• Atherosclerosis
• Ischemia
• Myocardial Infarction
• Cerebrovascular Accident

Intervention

• Drug: Vorapaxar 2.5 mg
  Vorapaxar 2.5 mg oral tablet
• Drug: Placebo
  matching placebo oral tablet

Study Arms

• Experimental: Vorapaxar
  Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
  Intervention: Drug: Vorapaxar 2.5 mg
• Placebo Comparator: Placebo
  Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 11, 2014): 258
• Original Estimated Enrollment (submitted: February 4, 2008): 200
• Actual Study Completion Date: October 1, 2010
• Actual Primary Completion Date: October 1, 2010 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: Canada, Colombia, Hungary, Israel, Netherlands, Sweden, United States

Administrative Information

• NCT Number: NCT00617123
• Other Study ID Numbers: P05183; MK-5348-018 ( Other Identifier: Merck Protocol Number )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
• URL: http://engagezone.msd.com/ds_documentation.php

• Responsible Party: Merck Sharp & Dohme Corp.
• Study Sponsor: Merck Sharp & Dohme Corp.

Collaborators

• The TIMI (Thrombolysis in Myocardial Infarction) Study Group
• Duke Clinical Research Institute

• Investigators: Not Provided
• PRS Account: Merck Sharp & Dohme Corp.
• Verification Date: August 2018