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

Roche

Status and phase: Completed; Phase 2

Conditions: Myocardial Infarction

Treatments: Drug: RO4905417; Procedure: Percutaneous Coronary Intervention (PCI); Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01327183

BP25619

Details and patient eligibility

About

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.

Enrollment: 532 patients

Sex: All

Ages: 19 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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532 participants in 3 patient groups, including a placebo group

20 mg/kg RO4905417 before PCI

Experimental group

Treatment:

Procedure: Percutaneous Coronary Intervention (PCI)

Drug: RO4905417

Drug: RO4905417

5 mg/kg RO4905417 before PCI

Experimental group

Treatment:

Procedure: Percutaneous Coronary Intervention (PCI)

Drug: RO4905417

Drug: RO4905417

Placebo before PCI

Placebo Comparator group

Treatment:

Procedure: Percutaneous Coronary Intervention (PCI)

Drug: placebo