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| ID | Type | Description | Link |
|---|---|---|---|
| MK-5348-018 | Other Identifier | Merck Protocol Number |
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| Name | Class |
|---|---|
| The TIMI Study Group | OTHER |
| Duke Clinical Research Institute | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vorapaxar | Experimental | Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year |
|
| Placebo | Placebo Comparator | Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vorapaxar 2.5 mg | Drug | Vorapaxar 2.5 mg oral tablet |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Develop Vacuolization in the Inner Nuclear Layer (INL) of the Retina as Measured by Ocular Coherence Tomography (OCT) | 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). | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Have a Decrease in Visual Acuity Score of at Least Seven Letters From Baseline | 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. |
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Inclusion Criteria:
Exclusion Criteria:
The study will include participants who meet none of the exclusion criteria for the parent protocol (P04737) and also the following:
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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A total of 258 particpants were referred to opthalmology sites, 65 of whom did not particpate in this study (P05138) beyond the screening visit and were not included in the analysis of ocular safety. A total of 193 participants were included in the analysis of ocular safety.
Participants were recruited from participants enrolled in Study SCH 530348 P04737 (NCT00526474) and met the inclusion/exclusion criteria for this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vorapaxar | Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year |
| FG001 | Placebo | Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Referral Screening Period |
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| |||||||||||||||||||||
| Study Treatment Period |
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Participants who were included in the analysis of ocular safety.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vorapaxar | Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year |
| BG001 | Placebo | Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Develop Vacuolization in the Inner Nuclear Layer (INL) of the Retina as Measured by Ocular Coherence Tomography (OCT) | 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). | The analysis population consisted of all participants who took at least one dose of study medication, and had a baseline and at least one post-baseline vacuolation assessment. | Posted | Number | participants | Up to 12 months |
|
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Participant safety data collected on the eCRF for this study (SCH 530348 P05183) were limited to ocular test results. These ocular test results were not captured as adverse events, but were captured as part of outcome measures. All other participant adverse events were collected under the Study SCH 530348 P04737 (NCT00526474) parent protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vorapaxar | Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D007511 | Ischemia |
| D009203 | Myocardial Infarction |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C530299 | vorapaxar |
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| Drug |
matching placebo oral tablet |
|
| Baseline and 4, 8 and 12 months |
| Number of Participants With Change From Baseline of Center Foveal Thickness of Greater Than 15 Microns as Measured by OCT | 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. | Baseline and 4, 8 and 12 months |
| Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by OCT | 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. | Baseline and 4, 8 and 12 months |
| Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by Fundus Photography | 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. | Baseline and 4, 8 and 12 months |
| Adverse Event |
|
| COMPLETED |
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| NOT COMPLETED |
|
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Placebo |
Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year |
|
|
| Secondary | Number of Participants Who Have a Decrease in Visual Acuity Score of at Least Seven Letters From Baseline | 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. | The analysis population consisted of all participants who took at least one dose of study medication, and had a baseline and at least one post-baseline visual acuity score. | Posted | Number | participants | Baseline and 4, 8 and 12 months |
|
|
|
| Secondary | Number of Participants With Change From Baseline of Center Foveal Thickness of Greater Than 15 Microns as Measured by OCT | 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. | The analysis population consisted of all participants who took at least one dose of study medication, and had a baseline and at least one post-baseline center point thickness assessment by OCT. | Posted | Number | participants | Baseline and 4, 8 and 12 months |
|
|
|
| Secondary | Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by OCT | 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. | The analysis population consisted of all participants who took at least one dose of study medication, and had a baseline and at least one post-baseline numerical score of graded abnormalities assessment by OCT. | Posted | Mean | Standard Error | score on a scale | Baseline and 4, 8 and 12 months |
|
|
|
| Secondary | Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by Fundus Photography | 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. | The analysis population consisted of all participants who took at least one dose of study medication, and had a baseline and at least one post-baseline numerical score of graded abnormalities assessment as measured by fundus photogrpahy. | Posted | Mean | Standard Error | score on a scale | Baseline and 4, 8 and 12 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Placebo | Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year | 0 | 0 | 0 | 0 |
The investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the study.
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D007238 | Infarction |
| D009336 | Necrosis |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| 12 months (n=78, n=78) |
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| 12 months (n=77, n=78) |
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| 8 months change (n=86, n=80) |
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| 12 months change (n=77, n=78) |
|
| 8 months change (n=86, n=80) |
|
| 12 months change (n=76, n=77) |
|