The purpose of this study is to examine the safety and efficacy of Angiomax as an
anticoagulation in patients with heparin-induced thrombocytopenia (HIT)/heparin-induced
thrombocytopenia with thrombosis syndrome (HITTS) undergoing off-pump coronary artery bypass
- 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 HIT antibodies (ELISA), AND/OR
2. HIT: Thrombocytopenia associated with heparin therapy, where the platelet count
has decreased by 50%, OR
3. HITTS: Thrombocytopenia (as defined in B above) PLUS any arterial or venous
thrombosis (Deep-vein thrombosis, pulmonary embolism, mesenteric venouse or
arterial thrombosis, acute myocardial infarction, left ventricular thrombus,
ischemic stroke, or occlusion of limb arteries) diagnosed by physical exam/lab
evidence and/or appropriate imaging studies (duplex ultrasound, venography,
ventilation-perfusion scan, venouse or arterial angiography, MRI/MRA,
- Confirmed pregnancy, by urine or serum pregnancy test (if woman of child-bearing
- Cerebrovascular accident within 6 months, or any cerebrovascular accident with a
residual neurological deficit.
- Intracranial neoplasm, arteriovenous malformation, or aneurysm.
- Dependency on renal dialysis or creatinine clearance <30mL/min.
- Ongoing treatment with warfarin (or other oral anticoagulant) at the time of
Patients previously treated with warfarin may be enrolled if warfarin therapy can be
safely discontinued and baseline INR is < 1.3 times control in the absence of heparin
- Known allergy to Angiomax or hirudin derived drugs, or known sensitivity to any
component of the product.
- Patients receiving clopidogrel (Plavix®) within the previous 5 days may be enrolled
if in the opinion of the Investigator the benefits of surgery outweigh the risk
associated with recent clopidogrel administration.
- Patients receiving a glycoprotein IIb/IIIa inhibitor within the previous 48 hours if
abciximab (ReoPro®) or 12 hours if eptifibatide (Integrilin®) or tirofiban
(Aggrastat®), may be enrolled if in the opinion of the investigator the benefits of
surgery outweigh the risk associated with not waiting the 48 or 12 hour time period
prior to enrollment.
- Patients receiving lepirudin (Refludan®) or argatroban within the previous 24 hours
prior to enrollment. Patients currently receiving lepirudin or argatroban can be
enrolled if they are switched to Angiomax at least 24 hours prior to the contemplated
- Patients receiving low molecular weight heparin (LMWH) or thrombolytics within the
previous 12 hours may be enrolled if in the opinion of the Investigator the benefits
of surgery outweigh the risk associated with not waiting the 12 hour time period.
- Participation in other clinical research studies involving the evaluation of other
investigational drugs or devices within 30 days of randomization.
- Refusal to undergo blood transfusion should it become necessary.
- Any other disease or condition, which, in the judgment of the investigator would
place a patient at undue risk by being enrolled in the trial or inability to comply
with study requirements.