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

This study has been completed.
Sponsor:
Collaborators:
The TIMI (Thrombolysis in Myocardial Infarction) Study Group
Duke Clinical Research Institute
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00617123
First received: February 4, 2008
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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).


Condition Intervention Phase
Atherosclerosis
Ischemia
Myocardial Infarction
Cerebrovascular Accident
Drug: Vorapaxar 2.5 mg
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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).


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 258
Study Start Date: July 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vorapaxar
Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
Drug: Vorapaxar 2.5 mg
Vorapaxar 2.5 mg oral tablet
Placebo Comparator: Placebo
Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
Drug: Placebo
matching placebo oral tablet

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00617123     History of Changes
Other Study ID Numbers: P05183, MK-5348-018
Study First Received: February 4, 2008
Results First Received: May 9, 2014
Last Updated: July 11, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Cerebral Infarction
Infarction
Myocardial Infarction
Stroke
Arterial Occlusive Diseases
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014