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



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:19 - 74
Updated:8/3/2016
Start Date:May 2011
End Date:October 2012

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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)

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.


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
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