Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00617123 | Trial to Assess the Ocular Safety of Vorapaxar (SCH 530348) in Participants With Atherosclerosis (Study P05183) | PHASE3 | COMPLETED | 258 | — | — | Jul 1, 2008 | Oct 1, 2010 | Sep 21, 2018 | - | — |
| NCT00526474 | Trial to Assess the Effects of Vorapaxar (SCH 530348; MK-5348) in Preventing Heart Attack and Stroke in Patients With Atherosclerosis (TRA 2°P - TIMI 50) (P04737) | PHASE3 | COMPLETED | 26,449 | — | — | Sep 1, 2007 | Dec 1, 2011 | Sep 21, 2018 | - | — |
| NCT00684203 | Trial to Assess the Safety and Effects of Vorapaxar in Japanese Subjects With Acute Coronary Syndrome (P04772; MK-5348-016) | PHASE2 | COMPLETED | 120 | — | — | Dec 1, 2006 | Oct 1, 2007 | May 5, 2017 | - | — |
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 time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, or UCR. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, or UCR within 3 years from randomization.
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.
| Arm | Type | Description |
|---|---|---|
| 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 |
| Vorapaxar 20 mg/1 mg | EXPERIMENTAL | Vorapaxar 20 mg loading dose + daily 1 mg maintenance dose + standard of care (Aspirin + Ticlopidine) |
| Vorapaxar 20 mg/2.5 mg | EXPERIMENTAL | Vorapaxar 20 mg loading dose + daily 2.5 mg maintenance dose + standard of care (Aspirin + Ticlopidine) |
| Vorapaxar 40 mg/1 mg | EXPERIMENTAL | Vorapaxar 40 mg loading dose + daily 1 mg maintenance dose + standard of care (Aspirin + Ticlopidine) |
| Vorapaxar 40 mg/2.5 mg | EXPERIMENTAL | Vorapaxar 40 mg loading dose + daily 2.5 mg maintenance dose + standard of care (Aspirin + Ticlopidine) |
| Name | Type | Description |
|---|---|---|
| Vorapaxar 2.5 mg | DRUG | Vorapaxar 2.5 mg oral tablet |
| Placebo | DRUG | matching placebo oral tablet |
| Vorapaxar | DRUG | 2.5-mg tablet daily for at least 1 year |
| Aspirin | DRUG | Loading dose of 75-325 mg on Day 1, then 75-100 mg once daily for 60 days. |
| Clopidogrel | DRUG | 100 mg two or three times daily for 60 days. |
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 o...