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 |
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.
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
We found this trial at
35
sites
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