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Comparing Angiomax to Heparin With Protamine Reversal in Patients OPCAB

Information source: The Medicines Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cardiac Surgery; Coronary Artery Bypass Surgery

Intervention: Bivalirudin (Drug); Heparin (Drug); Protamine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: The Medicines Company

Official(s) and/or principal investigator(s):
Andrew Sternlicht, MD, Study Director, Affiliation: The Medicines Company


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.

Clinical Details

Official title: A Study Comparing Angiomax (Bivalirudin) to Heparin With Protamine Reversal in Patients Undergoing Coronary Artery Bypass (OPCAB) Surgery

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:


Q-wave MI

Repeat Coronary Revascularization,

Stroke (hemorrhagic or ischemic).


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.



- Provide written informed consent before initiation of any study related procedures.

- Be at least 18 years of age.

- Be accepted for elective off-pump coronary artery bypass graft (CABG) surgery without

concomitant cardiac surgical procedures.

- < 4 planned Coronary Artery Bypass Grafts


- Any prior Cardio-Thoracic Surgical procedures requiring median sternotomy

- Confirmed pregnancy - baseline urine or serum pregnancy test (if woman of

childbearing potential).

- Cerebrovascular accident within 6 months before randomization, or any cerebrovascular

accident with 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 anticoagulants) at the time of

randomization. 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 therapy.

- Known allergy to Angiomax or hirudin derived drugs, or known sensitivity to any

component of these products.

- Patients receiving clopidogrel within the previous 5 days of randomization.

- Patients receiving a glycoprotein IIb/IIIa inhibitor within 48 hours if abciximab

(ReoPro) or within 24 hours if eptifibatide (Integrilin) and tirofiban (Aggrastat) of randomization

- Patients receiving lepirudin or argatroban within the previous 24 hours of


- Patients receiving low molecular weight heparin (LMWH) or thrombolytics within the

previous 12 hours or unfractionated heparin within 30 minutes of randomization.

- Patients with active or prior history of heparin-induced thrombocytopenia

(HIT)/heparin-induced thrombocytopenia and thrombosis syndrome (HITTS)*.

- 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.

Locations and Contacts

Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States
Additional Information

Starting date: August 2003
Last updated: November 8, 2011

Page last updated: August 23, 2015

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