Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00073580 | Angiomax in Patients With HIT/HITTS Type II Undergoing Off-Pump Coronary Artery Bypass Grafting (CABG) (CHOOSE) | PHASE3 | COMPLETED | 88 | — | — | Oct 1, 2003 | - | Nov 30, 2018 | 1 | United States |
: In-hospital acute procedural success, defined as the absence of death, Q wave myocardial infarction (MI), repeat coronary revascularization, and stroke (hemorrhagic or ischemic) at hospital discharge or Day 7 after surgery ('Day 7/discharge'), whichever occurs first.
| Name | Type | Description |
|---|---|---|
| Angiomax (bivalirudin) anticoagulant | DRUG | ): 250 mg vial administered as 0.75 mg/kg intravenous (IV) bolus and 1.75 mg/kg/h IV infusion for the duration of the procedure with the option to increase or decrease the infusion rate 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. A low-dose infusion could be administered in the preoperative phase (up to 48 hours before the procedure) and in the postoperative phase (up to 14 days after the procedure) as clinically indicated for management of HIT/TS. An initial dose of 0.1 mg/kg IV bolus followed by an IV infusion of 0.2 mg/kg/h titrated to a desired activated partial thromboplastin time (aPTT), eg, 1.5-2.5 times baseline aPTT, was recommended. |
Inclusion: * Be at least 18 years of age. * Be accepted for OPCAB graft surgery (repeat CABG eligible) * New diagnosis or history of objectively documented HIT/HITTS Type II, defined as: 1. Positive heparin-induced platelet aggregation (HIPA) or other functional assay for HIT or immunoassay for ...