Clinical trial NCT00073593: Comparing Angiomax to Heparin With Protamine Reversal in Patients OPCAB
Official title: A Study Comparing Angiomax (Bivalirudin) to Heparin With Protamine Reversal in Patients Undergoing Coronary Artery Bypass (OPCAB) Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiac Surgery
Coronary Artery Bypass Surgery
Keywords: Off-Pump Coronary Artery Bypass Graft Surgery
CABG
OPCAB
Heparin
Patients requiring off-pump CABG
Lead sponsor: The Medicines Company
Sponsor class: INDUSTRY
First posted: 2003-11-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion:

* 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

Exclusion:

* 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 randomization.
* 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.

Primary outcomes:
measure: Death
timeFrame: Hospital discharge or Day 7
measure: Q-wave MI
timeFrame: hospital discharge or day 7,
measure: Repeat Coronary Revascularization,
timeFrame: hospital discharge or day 7,
measure: Stroke (hemorrhagic or ischemic).
timeFrame: hospital discharge or day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Medicines Company
name: Andrew Sternlicht, MD
role: STUDY_DIRECTOR
References: