A Study of RO4905417 in Patients With Non ST-Elevation Myocardial Infarction (Non-STEMI) Undergoing Percutaneous Coronary Intervention

• Change from baseline in troponin I at 8 hours post PCI [ Time Frame: from baseline to 8 hours post PCI ] [ Designated as safety issue: No ]
• Peak and AUC for troponin I [ Time Frame: 24 hours post PCI ] [ Designated as safety issue: No ]
• Change from baseline in Creatine Kinase-Myocardial Band (CK-MB) after PCI [ Time Frame: from baseline to 24 hours post PCI ] [ Designated as safety issue: No ]
• Change form baseline in Growth Differentiation Factor 15 (GDF-15) at 120 days post PCI [ Time Frame: from baseline to Day 120 post PCI ] [ Designated as safety issue: No ]
• Change from baseline in cystatin C biomarker at 24 hours and 30 days post PCI [ Time Frame: from baseline to Day 30 post PCI ] [ Designated as safety issue: No ]
• Safety: Incidence of adverse events and major adverse cardiovascular events (MACEs) [ Time Frame: 120 days ] [ Designated as safety issue: No ]

This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of RO4905417 in patients with non ST-elevation myocardial infarction (Non-STEMI) undergoing percutaneous coronary intervention (PCI). Patients will be randomized to receive an intravenous infusion of either 5 mg/kg RO4905417 or 20 mg/kg RO4905417 or placebo before PCI. Follow-up will be for 4 months.

• Drug: RO4905417
  5 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI
• Drug: RO4905417
  20 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI
• Drug: placebo
  iv infusion, completed at least 1 hour and up to 24 hours before PCI
• Procedure: Percutaneous Coronary Intervention (PCI)
  at least 1 hour and up to 24 hours after completion of drug infusion

• Experimental: 1
  Interventions:

  • Drug: RO4905417
  • Procedure: Percutaneous Coronary Intervention (PCI)
• Experimental: 2
  Interventions:

  • Drug: RO4905417
  • Procedure: Percutaneous Coronary Intervention (PCI)
• Placebo Comparator: 3
  Interventions:

  • Drug: placebo
  • Procedure: Percutaneous Coronary Intervention (PCI)

Inclusion Criteria:

• Adult patients, >18 to <75 years of age
• Non ST-elevation myocardial infarction
• Woman of childbearing potential will be allowed only if using two acceptable methods of contraception
• Body mass index (BMI) </= 40 kg/m2

Exclusion Criteria:

• Acute ST-elevation myocardial infarction (STEMI)
• Culprit coronary lesion with a total thrombotic occlusion or a lesion requiring the use of distal embolization protection or thrombectomy devices
• Percutaneous coronary intervention (PCI) within the past 72 hours
• Thrombolytic therapy within the past 7 days
• Major surgery within the past 3 months
• History of cerebral vascular disease or stroke in the past 3 months
• Bleeding disorders
• Inadequately controlled severe hypertension
• Prior coronary artery bypass graft (CABG) surgery
• Decompensated heart failure (oedema and/or rale)
• Acute infection at screening or active chronic infection within 3 months prior to PCI
• Patients known to be HIV positive, patients receiving antiretroviral drugs, or immuno-suppressed patients
• Uncontrolled diabetes mellitus (HbA1C >10%) at baseline