Comparing Angiomax to Heparin With Protamine Reversal in Patients OPCAB

NCT00073593 | Completed Phase 3

• 2 other identifiers: TMC-BIV-02-07EVOLUTION
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery; Coronary Artery Bypass Surgery

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Death

  Hospital discharge or Day 7

• Q-wave MI

  hospital discharge or day 7,

• Repeat Coronary Revascularization,

  hospital discharge or day 7,

• Stroke (hemorrhagic or ischemic).

  hospital discharge or day 7

Study Arms (2)

bivalirudin

EXPERIMENTAL

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

heparin/protamine

ACTIVE COMPARATOR

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; Drug: Protamine

Interventions

Bivalirudin DRUG

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).

bivalirudin

Heparin DRUG

: 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.

heparin/protamine

Protamine DRUG

Per institutional practice. Batches from hospital stock.

heparin/protamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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 accepted for elective off-pump coronary artery bypass graft (CABG) surgery without concomitant cardiac surgical procedures.
• \< 4 planned Coronary Artery Bypass Grafts

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Medicines Company: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

bivalirudin; Heparin; Protamines

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Nuclear Proteins; Proteins; Amino Acids, Peptides, and Proteins; Nucleoproteins

Study Officials

• Andrew Sternlicht, 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: November 26, 2003
• First Posted: November 27, 2003
• Study Start: August 1, 2003
• Primary Completion: May 1, 2004
• Last Updated: November 10, 2011

Record last verified: 2011-11

Locations

US (1)