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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Study of SCH 530348 in Subjects With Cerebral Infarction

Brief Summary: 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.

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome: Number of Participants Experiencing Non-Major Adverse Cardiac Events (Non-MACE) [ Time Frame: Up to Day 121 ]

Original Primary Outcome: The primary endpoint is the incidence of adverse events by treatment group [ Time Frame: During treatment with study drug ]

Current Secondary Outcome:

• Number of Paticipants Experiencing Thrombolysis in Myocardial Infarction (TIMI) Major, Minor, and Non-TIMI Bleeding Events [ Time Frame: Up to Day 60 ]
  Major TIMI bleeding was defined as any intracranial bleeding (excluding micohemorrhages <10 mm evident on magnetic resonance imaging [MRI]), clinical over signs of hemorrhge associated with a drop in hemoglobin >=5 g/dL, or fatal bleeding (bleeding that directly results in death within 7 days). Minor TIMI bleeding was defined as any clinically overt bleeding resulting in a hemoglobin drop of 3 to <5 g/dL. Non-TIMI bleeding included all bleeding events not covered under Major TIMI or Minor TIMI bleeding.
• Number of Participants With MACE or Death [ Time Frame: Up to Day 121 ]
  The number of participants experiencing major cardiac events or death was evaluated up to Day 121. Major cardiac events were defined as nonfatal stroke, hospitalization due to recurrent ischemia, or urgent coronary revascularization.
• Median High-Sensitivity C-Reactive Protein (Hs-CRP) Levels By Study Visit [ Time Frame: Up to Day 60 ]
  Participant blood samples were collected to determine the median serum level of hs-CRP. hs-cRP levels reflect the underlying level of inflammation. The higher the level, the greater the disease burden.
• Mean CD40 Ligand Levels By Study Visit [ Time Frame: Up to Day 60 ]
  Participant blood samples were collected to determine the mean serum level of CD40 ligand. CD40 ligand values represent the level of disease activation with a higher level of CD40 ligand indicating a greater underlying risk.
• Mean Membrane-Bound P-Selectin Levels By Study Visit [ Time Frame: Up to Day 60 ]
  Participant blood samples were collected at Baseline, Day 30, and Day 60 to determine the mean level of membrane-bound p-selectin in the serum. Membrane-bound P-selectin levels reflect the underlying level of inflammation. Intensity levels are reported in arbitrary units 0 (dark) to 1023 (bright). Higher values correspond to greater membrane-bound P-Selectin levels.

Original Secondary Outcome:

• Secondary endpoint is incidence of adverse events by treatment group. [ Time Frame: Through treatment period and post treatment observation period ]
• 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. [ Time Frame: During treatment with study drug ]
• 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. [ Time Frame: To the end of the post treatment observation period 60 days post dose ]

Dates:
Date Received: May 22, 2008
Date Started: September 21, 2006
Date Completion:
Last Updated: March 31, 2017
Last Verified: March 2017