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Comparing Angiomax to Heparin With Protamine Reversal in Patients OPCAB (OPCAB)

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ClinicalTrials.gov Identifier: NCT00073593
Recruitment Status : Completed
First Posted : November 27, 2003
Last Update Posted : November 10, 2011
Sponsor:
Information provided by (Responsible Party):
The Medicines Company

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.

Condition or disease Intervention/treatment Phase
Cardiac Surgery Coronary Artery Bypass Surgery Drug: Bivalirudin Drug: Heparin Drug: Protamine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study Comparing Angiomax (Bivalirudin) to Heparin With Protamine Reversal in Patients Undergoing Coronary Artery Bypass (OPCAB) Surgery
Study Start Date : August 2003
Actual Primary Completion Date : May 2004

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Arm Intervention/treatment
Experimental: bivalirudin
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
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).

Active Comparator: heparin/protamine
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
: 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.

Drug: Protamine
Per institutional practice. Batches from hospital stock.




Primary Outcome Measures :
  1. Death [ Time Frame: Hospital discharge or Day 7 ]
  2. Q-wave MI [ Time Frame: hospital discharge or day 7, ]
  3. Repeat Coronary Revascularization, [ Time Frame: hospital discharge or day 7, ]
  4. Stroke (hemorrhagic or ischemic). [ Time Frame: hospital discharge or day 7 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00073593


Locations
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United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Medicines Company
Investigators
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Study Director: Andrew Sternlicht, MD The Medicines Company

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Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT00073593     History of Changes
Other Study ID Numbers: TMC-BIV-02-07
EVOLUTION
First Posted: November 27, 2003    Key Record Dates
Last Update Posted: November 10, 2011
Last Verified: November 2011
Keywords provided by The Medicines Company:
Off-Pump Coronary Artery Bypass Graft Surgery
CABG
OPCAB
Heparin
Patients requiring off-pump CABG
Additional relevant MeSH terms:
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Protamines
Heparin
Calcium heparin
Hirudins
Benzocaine
Bivalirudin
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Heparin Antagonists
Coagulants