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

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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:
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  ICMJE February 4, 2008
First Posted Date  ICMJE February 15, 2008
Results First Submitted Date  ICMJE May 9, 2014
Results First Posted Date  ICMJE July 14, 2014
Last Update Posted Date September 21, 2018
Actual Study Start Date  ICMJE July 1, 2008
Actual Primary Completion Date October 1, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Trial to Assess the Ocular Safety of Vorapaxar (SCH 530348) in Participants With Atherosclerosis (Study P05183)
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Atherosclerosis
  • Ischemia
  • Myocardial Infarction
  • Cerebrovascular Accident
Intervention  ICMJE
  • Drug: Vorapaxar 2.5 mg
    Vorapaxar 2.5 mg oral tablet
  • Drug: Placebo
    matching placebo oral tablet
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2014)
258
Original Estimated Enrollment  ICMJE
 (submitted: February 4, 2008)
200
Actual Study Completion Date  ICMJE October 1, 2010
Actual Primary Completion Date October 1, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Canada,   Colombia,   Hungary,   Israel,   Netherlands,   Sweden,   United States
 
Administrative Information
NCT Number  ICMJE NCT00617123
Other Study ID Numbers  ICMJE P05183
MK-5348-018 ( Other Identifier: Merck Protocol Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE
  • The TIMI (Thrombolysis in Myocardial Infarction) Study Group
  • Duke Clinical Research Institute
Investigators  ICMJE Not Provided
PRS Account Merck Sharp & Dohme Corp.
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP