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

Completed · Phase 2 · Has a placebo group

Conditions studied: Myocardial Infarction

In brief

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.

Key facts

Study ID

NCT01327183

Run by

Hoffmann-La Roche

People needed

532

Starts

2011-05-01

Expected to finish

2012-10-01

Last updated by the study team

2016-11-02

Who can join

Age: 19 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Los Angeles, California, United States
• Study site — Salinas, California, United States
• Study site — Littleton, Colorado, United States
• Study site — Farmington, Connecticut, United States
• Study site — Boynton Beach, Florida, United States
• Study site — Kissimmee, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Vero Beach, Florida, United States
• Study site — Columbus, Georgia, United States
• Study site — Aurora, Illinois, United States
• Study site — Fort Wayne, Indiana, United States
• Study site — Iowa City, Iowa, United States
• Study site — Wichita, Kansas, United States
• Study site — Louisville, Kentucky, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Baltimore, Massachusetts, United States
• Study site — Hyannis, Massachusetts, United States
• Study site — Bay City, Michigan, United States
• Study site — Petoskey, Michigan, United States
• Study site — Saint Paul, Minnesota, United States
• Study site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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