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
Merck Sharp & Dohme Corp.
The TIMI (Thrombolysis in Myocardial Infarction) Study Group
Duke Clinical Research Institute
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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 or disease||Intervention/treatment||Phase|
|Atherosclerosis Ischemia Myocardial Infarction Cerebrovascular Accident||Drug: Vorapaxar 2.5 mg Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||258 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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)|
|Actual Study Start Date :||July 1, 2008|
|Actual Primary Completion Date :||October 1, 2010|
|Actual Study Completion Date :||October 1, 2010|
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
matching placebo oral tablet
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 ]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 ]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.
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