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

NCT00079586 | Completed Phase 3

• 2 other identifiers: TMC-BIV-02-06EVOLUTION-On
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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 Arms (2)

Heparin

ACTIVE COMPARATOR

unfractionated heparin will be administered as per institutional practice

Drug: Heparin

Angiomax

EXPERIMENTAL

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

Drug: Bivalirudin

Interventions

Heparin DRUG

Unfractionated Heparin per institutional practice

Heparin

Bivalirudin DRUG

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

Angiomax

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Medicines Company: lead

Study Sites (1)

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Heparin; bivalirudin

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Malcolm Lloyd, MD

  The Medicines Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2004
• First Posted: March 11, 2004
• Study Start: April 1, 2004
• Study Completion: November 1, 2004
• Last Updated: January 5, 2012

Record last verified: 2012-01

Locations

US (1)