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Comparing Angiomax to Heparin With Protamine Reversal in Patients OPCAB

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00073593
Acronym
OPCAB
Enrollment
150
Registered
2003-11-27
Start date
2003-08-31
Completion date
Unknown
Last updated
2011-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Coronary Artery Bypass Surgery

Keywords

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

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.

Interventions

DRUGBivalirudin

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).

DRUGHeparin

: 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.

Per institutional practice. Batches from hospital stock.

Sponsors

The Medicines Company
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frame
Repeat Coronary Revascularization,hospital discharge or day 7,
DeathHospital discharge or Day 7
Q-wave MIhospital discharge or day 7,
Stroke (hemorrhagic or ischemic).hospital discharge or day 7

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026