Myocardial Infarction
Conditions
Brief summary
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.
Interventions
PROCEDUREPercutaneous Coronary Intervention (PCI)
at least 1 hour and up to 24 hours after completion of drug infusion
DRUGRO4905417
5 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI
DRUGplacebo
iv infusion, completed at least 1 hour and up to 24 hours before PCI
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 from baseline in troponin I at 8 hours post PCI | from baseline to 8 hours 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 |
| Change form baseline in Growth Differentiation Factor 15 (GDF-15) at 120 days post PCI | from baseline to Day 120 post PCI |
Countries
Canada, Netherlands, Poland, United States
Outcome results
None listed