Comparing Angiomax to Heparin With Protamine Reversal in Patients OPCAB

Cardiac Surgery Clinical Trial

— OPCAB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00073593
• Other study ID #: TMC-BIV-02-07
• Secondary ID: EVOLUTION
• Status: Completed
• Phase: Phase 3
• First received: November 26, 2003
• Last updated: November 8, 2011
• Start date: August 2003

Study information

• Verified date: November 2011
• Source: The Medicines Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. primary completion date: May 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Cardiac Surgery
• Coronary Artery Bypass Surgery

Intervention

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).
• 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.
• Protamine
Per institutional practice. Batches from hospital stock.

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Medicines Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death		Hospital discharge or Day 7	Yes
Primary	Q-wave MI		hospital discharge or day 7,	Yes
Primary	Repeat Coronary Revascularization,		hospital discharge or day 7,	Yes
Primary	Stroke (hemorrhagic or ischemic).		hospital discharge or day 7	Yes