The purpose of this study is to examine the safety and efficacy of Angiomax as an alternative anticoagulant to heparin with protamine reversal in patients undergoing off-pump coronary artery bypass graft surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
250 mg vial administered as 0.75 mg/kg intravenous (IV) bolus and 1.75 mg/kg/h IV infusion for the duration of surgery with the option to increase or decrease the infusion in 0.25 mg/kg/h increments or to administer additional 0.1-0.5 mg/kg boluses to maintain an activated clotting time (ACT) \>300 seconds (s).
: Per institutional practice, at 1.5-3.5 mg/kg (200-400 U/kg) IV bolus to achieve a target ACT of \>300 s followed by weight-adjusted boluses as needed during surgery to achieve/maintain the target ACT. Batches from hospital stock.
Per institutional practice. Batches from hospital stock.
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Death
Time frame: Hospital discharge or Day 7
Q-wave MI
Time frame: hospital discharge or day 7,
Repeat Coronary Revascularization,
Time frame: hospital discharge or day 7,
Stroke (hemorrhagic or ischemic).
Time frame: hospital discharge or day 7
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