Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SCH 530348 (high percentage), Vorapaxar, MK-5348
SCH 530348 · 8 trials · 12 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.
Mean of week 8 and week 12 minus week 0 (on log10 scale) then back transforming the log10 difference to obtain percentage change from baseline.
| 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 |
| Standard Percentage | EXPERIMENTAL | - |
| High Percentage | EXPERIMENTAL | - |
| 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 |
| SCH 530348 | DRUG | - |
| Pantoprazole | DRUG | 40 mg delayed-release tablet administered orally in the morning of Days 1-7 |
| SCH 530348 (high percentage) | DRUG | 2.5 mg tablet containing \~46% active pharmaceutical ingredient (API) as free base (46+5%) administered orally on the morning of Day 5 |
| SCH 530348 (standard percentage) | DRUG | 2.5 mg tablet containing \~23% API as free base (STANDARD) administered orally on the morning of Day 5 |
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...
SCH 530348 is an investigational small molecule being studied in cardiovascular medicine for acute coronary syndrome and arterial obstructive diseases. It has been evaluated in clinical trials involving patients undergoing non-emergent percutaneous coronary intervention, as well as in bioequivalence studies of its 2.5 mg tablet formulation.
SCH 530348 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker symbol MRK. Merck is the sponsor responsible for the clinical development program of this small molecule cardiovascular candidate.
SCH 530348 is in Phase 1 development. It is an investigational drug and has not been approved by the FDA. Clinical work to date includes a completed Phase 1 bioequivalence study and a completed Phase 2 safety study in patients undergoing non-emergent percutaneous coronary intervention.
SCH 530348 has been studied in two completed trials. NCT01358344 was a Phase 1 bioequivalence study of SCH 530348 2.5 mg tablets with 173 healthy volunteers. NCT00132912 was a Phase 2 safety study in 1,030 subjects undergoing non-emergent percutaneous coronary intervention.
Yes. SCH 530348 (high percentage) is an alternative name used for SCH 530348, the investigational cardiovascular small molecule developed by Merck & Company, Inc. Both names refer to the same drug candidate studied in acute coronary syndrome and arterial obstructive diseases.