Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vorapaxar · 5 trials · 8 indications
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.
Time to AV fistula functional maturation (defined as successful cannulation of the AV fistula for six hemodialysis sessions within three weeks).
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.
An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporarily associated with study drug administration, whether or not considered related to study drug. MACE events were defined as nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization. All MACE events were excluded from this analysis.
| 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 intervention | ACTIVE_COMPARATOR | This arm will receive the study drug: Vorapaxar sulfate. The investigators expect to enroll 128 patients. Patients will be assigned to treatment groups with a 1:1 randomization in blocks of 4 at the conclusion of the AV fistula creation. Patients will be stratified based on fistula location (lower arm versus upper arm). |
| Placebo intervention | PLACEBO_COMPARATOR | This arm will receive the matching placebo. The investigators expect to enroll 128 patients. Patients will be assigned to treatment groups with a 1:1 randomization in blocks of 4 at the conclusion of the AV fistula creation. Patients will be stratified based on fistula location (lower arm versus upper arm). |
| 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) |
| Vorapaxar 2.5 mg + Aspirin | EXPERIMENTAL | Vorapaxar oral tablets; once daily for 60 days + Aspirin. |
| Vorapaxar 1 mg + Aspirin | EXPERIMENTAL | Vorapaxar oral tablets; once daily for 60 days + Aspirin. |
| Placebo + Aspirin | PLACEBO_COMPARATOR | Placebo oral tablets; once daily for 60 days + Aspirin |
| 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 |
| Vorapaxar sulfate | DRUG | The study drug (12-week supply of study drug) will be dispensed to enrolled patients on the first day following surgery. |
| 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. |
| Vorapaxar 1 mg | DRUG | Oral tablets; once daily for 60 days |
| Aspirin 75-150 mg | DRUG | oral tablets; once 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...
Vorapaxar is an investigational small molecule being studied for use in cerebral infarction, atherosclerosis, and AV fistula. It has been evaluated in clinical trials for conditions related to atherosclerosis, ischemia, myocardial infarction, cerebrovascular accident, and peripheral arterial disease. Vorapaxar is not FDA approved and remains in clinical development.
Vorapaxar is a small molecule that targets the protease-activated receptor-1 (PAR-1), which is a thrombin receptor on platelets. By inhibiting PAR-1, vorapaxar is designed to reduce platelet activation and thrombus formation, which is relevant to its study in atherosclerotic and ischemic conditions.
Vorapaxar is being developed by Merck & Company, Inc., which is publicly traded under the ticker symbol MRK. Merck has sponsored multiple clinical trials of vorapaxar across different indications, including atherosclerosis and AV fistula.
Vorapaxar is in Phase 2 clinical development. While some completed trials were Phase 3, the most recent development stage is Phase 2, and the drug is not FDA approved. It remains investigational and is not yet available for commercial use.
Vorapaxar has completed three clinical trials: NCT00526474, a Phase 3 trial in atherosclerosis with 26,449 participants; NCT00617123, a Phase 3 ocular safety study in atherosclerosis with 258 participants; and NCT00684203, a Phase 2 trial in Japanese subjects with acute coronary syndrome. A Phase 2 trial for AV fistula maturation, NCT02475837, enrolled 17 participants.
Yes, Vorapaxar is also known as SCH 530348 and MK-5348. These alternative names appear in clinical trial titles and identifiers, such as in the TRA 2°P - TIMI 50 trial, which refers to vorapaxar as SCH 530348 and MK-5348.