Comparing Angiomax to Heparin With Protamine Reversal in Patients OPCAB - Full Text View

Sponsor:	The Medicines Company
Information provided by (Responsible Party):	The Medicines Company
ClinicalTrials.gov Identifier:	NCT00073593

Purpose

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.

Condition	Intervention	Phase
Cardiac Surgery Coronary Artery Bypass Surgery	Drug: Bivalirudin Drug: Heparin Drug: Protamine	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Study Comparing Angiomax (Bivalirudin) to Heparin With Protamine Reversal in Patients Undergoing Coronary Artery Bypass (OPCAB) Surgery

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners Coronary Artery Bypass Surgery

Drug Information available for: Bivalirudin Heparin Protamine

U.S. FDA Resources

Further study details as provided by The Medicines Company:

Primary Outcome Measures:

Death [ Time Frame: Hospital discharge or Day 7 ] [ Designated as safety issue: Yes ]
Q-wave MI [ Time Frame: hospital discharge or day 7, ] [ Designated as safety issue: Yes ]
Repeat Coronary Revascularization, [ Time Frame: hospital discharge or day 7, ] [ Designated as safety issue: Yes ]
Stroke (hemorrhagic or ischemic). [ Time Frame: hospital discharge or day 7 ] [ Designated as safety issue: Yes ]

Enrollment:	150
Study Start Date:	August 2003
Primary Completion Date:	May 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: bivalirudin 250mg vial given as 0.75mg/kg intravenous (IV) bolus and 1.75 mg/kg/hr IV infusion for the duration of the procedure with the option to increase or decrease the infusion in 0.25 mg/kg/hr increments or to administer additional 0.1-0.5 mg/kg boluses to maintain an ACT>300 seconds.	Drug: Bivalirudin 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).
Active Comparator: heparin/protamine 1.5-3.5 mg/kg (200-400 U/kg) intravenous (IV) bolus to target an ACT >300 seconds followed by weight-adjusted boluses as needed during the procedure to achieve/maintain the target ACT. Protamine as needed	Drug: Heparin : 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. Drug: Protamine Per institutional practice. Batches from hospital stock.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073593

Locations

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

Sponsors and Collaborators

The Medicines Company

Investigators

Study Director:

Andrew Sternlicht, MD

The Medicines Company

More Information

No publications provided

Responsible Party:	The Medicines Company
ClinicalTrials.gov Identifier:	NCT00073593 History of Changes
Other Study ID Numbers:	TMC-BIV-02-07, EVOLUTION
Study First Received:	November 26, 2003
Last Updated:	November 8, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by The Medicines Company:

Off-Pump Coronary Artery Bypass Graft Surgery
CABG
OPCAB
Heparin
Patients requiring off-pump CABG

Additional relevant MeSH terms:

Calcium heparin
Bivalirudin
Heparin
Protamines
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents

Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Heparin Antagonists
Coagulants
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 12, 2012