A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety and Tolerability of 20mg/kg Dose of RO4905417 Administered Every Four Weeks for 32 Weeks in Patients Undergoing Coronary Artery Bypass Graft Surgery (CABG)
Multi-center, randomized, double-blind, placebo-controlled,
single-dose (one dose level) study comparing 20 mg/kg dose of
RO4905417 versus a matching placebo.
Patients will be randomized to receive either:
-Placebo administered over a minimum of 1 hour infusion once every 4 weeks.
-20 mg/kg of RO4905417 administered over a minimum of 1 hour infusion once
every 4 weeks.
The study will consist of a screening phase (up to 6 weeks); a
randomization visit (Week 0); a 32-week double-blind treatment
period (9 infusions administered at 4 week intervals (Weeks
0,4,8,12,16,20,24,28 and 32); coronary angiography performedone year after randomization (Week 52 +/- 4 weeks); and a phone contact for safety follow up at Weeks 36 and 62.
The first infusion will be started in the operating room immediately following the CABG procedure (after completion of protamine administration). If surgery is performed on-pump, the first infusion is started after the patient is weaned from the extra-corporeal circulation.
Baseline will correspond to assessments and blood sampling performed before
the CABG surgery and first infusion at Week 0.
Patients must meet ALL of the following inclusion criteria in order to be eligible for this
1. Patients undergoing primary multi-vessel CABG with at least one saphenous vein
graft, with or without cardiopulmonary bypass (no minimally invasive surgery allowed).
2. Patients > 18 years old and < 85 years
3. Patients must be able and willing to give written informed consent
4. Women of childbearing potential will be allowed only if using two acceptable
methods of contraception.
5. BMI less than or equal to 40kg/m^2 (maximal body weight of 135 kg).
6. Patients who, in the opinion of the investigator, are able and willing to comply with
the protocol for the duration of the study