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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

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) 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