Comparing Angiomax to Heparin With Protamine in Patients Undergoing Cardiopulmonary Bypass (CPB)

NCT ID: NCT00079586

Last Updated: 2012-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2004-11-30

Brief Summary

The purpose of this study is to demonstrate that in patients undergoing coronary artery bypass grafting (CABG) or CABG-Valve, or Isolated Cardiac Valve surgery on CPB (cardiac surgery), Angiomax is a safe and effective alternative anticoagulant to heparin with protamine reversal.

Conditions

Cardiovascular Disease; Coronary Artery Bypass Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Heparin

unfractionated heparin will be administered as per institutional practice

Group Type: ACTIVE_COMPARATOR

Heparin

Intervention Type: DRUG

Unfractionated Heparin per institutional practice

Angiomax

1.0 mg/kg IV bolus followed by a 2.5 mg/kg/hr IV infusion

Group Type: EXPERIMENTAL

Bivalirudin

Intervention Type: DRUG

1.0 mg/kg IV bolus followed by a 2.5 mg/kg/hr IV infusion

Interventions

Heparin

Unfractionated Heparin per institutional practice

Intervention Type: DRUG

Bivalirudin

1.0 mg/kg IV bolus followed by a 2.5 mg/kg/hr IV infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Provide written informed consent before initiation of any study related procedures.
• Be at least 18 years of age.
• Be scheduled for CABG, CABG and single valve surgery, or isolated single valve surgery on CPB. Patients undergoing repeat (redo) CABG are also considered eligible for this study.

Exclusion Criteria

• Confirmed pregnancy at time of randomization via IVRS (if woman of child-bearing potential) (Urine or serum pregnancy test)
• 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 <30 mL/min.
• Ongoing treatment with warfarin (or other oral anticoagulant) 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 the product.
• Patients receiving clopidogrel (Plavix®) within the previous 5 days of randomization
• Patients receiving a glycoprotein IIb/IIIa inhibitor within the previous 48 hours if abciximab (ReoPro®) or 24 hours if eptifibatide (Integrilin®) or tirofiban (Aggrastat®) of randomization.
• Patients receiving lepirudin (Refludan®) or argatroban within the previous 24 hours prior to randomization.
• Patients receiving LMWH or thrombolytics within the previous 12 hours or unfractionated heparin within 30 minutes of randomization.
• 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 cause inability to comply with the trial.
• Planned surgical procedure in which proximal anastomoses will precede distal anastomoses of the bypass grafts.
• Planned (>1) double (or greater) valve repair-replacement (e.g.: AVR-MVR) surgery.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Medicines Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Malcolm Lloyd, MD

Role: STUDY_DIRECTOR

The Medicines Company

Locations

The Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

EVOLUTION-On

Identifier Type: -

Identifier Source: secondary_id

TMC-BIV-02-06

Identifier Type: -

Identifier Source: org_study_id