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

Study Overview
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Brief Summary
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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.

Official Title
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A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF 2 DOSES OF RO4905417 (R1512) ADMINISTERED TO PATIENTS WITH NON ST-ELEVATION MYOCARDIAL INFARCTION (NON-STEMI) UNDERGOING PERCUTANEOUS CORONARY INTERVENTION (PCI)

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Procedure: Percutaneous Coronary Intervention (PCI)
* Drug: RO4905417
* Drug: RO4905417
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 20 mg/kg RO4905417 before PCI<br> | Procedure: Percutaneous Coronary Intervention (PCI)<br>* at least 1 hour and up to 24 hours after completion of drug infusion<br>Drug: RO4905417<br>* 20 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI<br>|
| Experimental: 5 mg/kg RO4905417 before PCI<br> | Procedure: Percutaneous Coronary Intervention (PCI)<br>* at least 1 hour and up to 24 hours after completion of drug infusion<br>Drug: RO4905417<br>* 5 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI<br>|
| Placebo Comparator: Placebo before PCI<br> | Procedure: Percutaneous Coronary Intervention (PCI)<br>* at least 1 hour and up to 24 hours after completion of drug infusion<br>Drug: placebo<br>* iv infusion, completed at least 1 hour and up to 24 hours before PCI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of procedural damage during percutaneous coronary intervention (PCI): Change from baseline in troponin I levels early after PCI |  | from baseline to 24 hours post PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in troponin I at 8 hours post PCI |  | from baseline to 8 hours post PCI | 
| Peak and AUC for troponin I |  | 24 hours post PCI | 
| Change from baseline in Creatine Kinase-Myocardial Band (CK-MB) after PCI |  | from baseline to 24 hours post PCI | 
| Change form baseline in Growth Differentiation Factor 15 (GDF-15) at 120 days post PCI |  | from baseline to Day 120 post PCI | 
| Change from baseline in cystatin C biomarker at 24 hours and 30 days post PCI |  | from baseline to Day 30 post PCI | 
| Safety: Incidence of adverse events and major adverse cardiovascular events (MACEs) |  | 120 days |