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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
532
Reduction of procedural damage during percutaneous coronary intervention (PCI): Change from baseline in troponin I levels early after PCI
Time frame: from baseline to 24 hours post PCI
Change from baseline in troponin I at 8 hours post PCI
Time frame: from baseline to 8 hours post PCI
Peak and AUC for troponin I
Time frame: 24 hours post PCI
Change from baseline in Creatine Kinase-Myocardial Band (CK-MB) after PCI
Time frame: from baseline to 24 hours post PCI
Change form baseline in Growth Differentiation Factor 15 (GDF-15) at 120 days post PCI
Time frame: from baseline to Day 120 post PCI
Change from baseline in cystatin C biomarker at 24 hours and 30 days post PCI
Time frame: from baseline to Day 30 post PCI
Safety: Incidence of adverse events and major adverse cardiovascular events (MACEs)
Time frame: 120 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
iv infusion, completed at least 1 hour and up to 24 hours before PCI
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Huntsville, Alabama, United States
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Tucson, Arizona, United States
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Los Angeles, California, United States
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Salinas, California, United States
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Littleton, Colorado, United States
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Farmington, Connecticut, United States
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Boynton Beach, Florida, United States
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Kissimmee, Florida, United States
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Ocala, Florida, United States
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Sarasota, Florida, United States
...and 56 more locations