Trial to Assess the Safety of Vorapaxar in Japanese Subjects With Cerebral Infarction (P05005; MK-5348-017)

Completed

Phase 2 Results

Trial Description

The study is designed to assess safety of Vorapaxar when added to standard of care (aspirin) in Japanese subjects with cerebral infarction. The study will assess incidence and tolerability of bleeding, major adverse cardiac events, all adverse events, and effect on expression of markers of inflammation.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: oral tablets; once daily for 60 days
    ARM 1: Kind: Experimental
    Label: Placebo + Aspirin
    Description: Placebo oral tablets; once daily for 60 days + Aspirin
  • SCH 530348 2.5 mg Drug
    Intervention Desc: oral tablets; once daily for 60 days
    ARM 1: Kind: Experimental
    Label: SCH 530348 2.5 mg + Aspirin
    Description: SCH 530348 oral tablets; once daily for 60 days + Aspirin
  • SCH 530348 1 mg Drug
    Intervention Desc: oral tablets; once daily for 60 days
    ARM 1: Kind: Experimental
    Label: SCH 530348 1 mg + Aspirin
    Description: SCH 530348 oral tablets; once daily for 60 days + Aspirin
  • Aspirin 75-150 mg Drug
    Intervention Desc: oral tablets; once daily for 60 days
    ARM 1: Kind: Experimental
    Label: SCH 530348 2.5 mg + Aspirin
    Description: SCH 530348 oral tablets; once daily for 60 days + Aspirin
    ARM 2: Kind: Experimental
    Label: SCH 530348 1 mg + Aspirin
    Description: SCH 530348 oral tablets; once daily for 60 days + Aspirin
    ARM 3: Kind: Experimental
    Label: Placebo + Aspirin
    Description: Placebo oral tablets; once daily for 60 days + Aspirin
    ARM 4: Kind: Experimental
    Label: Vorapaxar 2.5 mg + Aspirin
    Description: Vorapaxar oral tablets; once daily for 60 days + Aspirin.
    ARM 5: Kind: Experimental
    Label: Vorapaxar 1 mg + Aspirin
    Description: Vorapaxar oral tablets; once daily for 60 days + Aspirin.
  • Vorapaxar 2.5 mg Drug
    Intervention Desc: Oral tablets; once daily for 60 days.
    ARM 1: Kind: Experimental
    Label: Vorapaxar 2.5 mg + Aspirin
    Description: Vorapaxar oral tablets; once daily for 60 days + Aspirin.
  • Vorapaxar 1 mg Drug
    Intervention Desc: Oral tablets; once daily for 60 days
    ARM 1: Kind: Experimental
    Label: Vorapaxar 1 mg + Aspirin
    Description: Vorapaxar oral tablets; once daily for 60 days + Aspirin.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary The primary endpoint is the incidence of adverse events by treatment group During treatment with study drug Yes
Secondary Secondary endpoint is incidence of adverse events by treatment group. Through treatment period and post treatment observation period Yes
Secondary Secondary endpoints evaluated TIMI major/minor and nonTIMI bleeding, first occurrence or certain combination of major adverse cardiac events and death, and change in hs-CRP, CD40 ligand, and membrane-bound P-selectin. During treatment with study drug Yes
Secondary Secondary endpoints evaluated TIMI major/minor and nonTIMI bleeding (4), first occurrence or certain combination of major adverse cardiac events and death, inhibition of platelet aggregation, and plasma drug concentration. To the end of the post treatment observation period 60 days post dose Yes
Primary Number of Participants Experiencing Non-Major Adverse Cardiac Events (Non-MACE) Up to Day 121 Yes
Secondary Number of Paticipants Experiencing Thrombolysis in Myocardial Infarction (TIMI) Major, Minor, and Non-TIMI Bleeding Events Up to Day 60 Yes
Secondary Number of Participants With MACE or Death Up to Day 121 Yes
Secondary Median High-Sensitivity C-Reactive Protein (Hs-CRP) Levels By Study Visit Up to Day 60 No
Secondary Mean CD40 Ligand Levels By Study Visit Up to Day 60 No
Secondary Mean Membrane-Bound P-Selectin Levels By Study Visit Up to Day 60 No

Sponsors