Study of NU172 as Anticoagulation in Patients Undergoing Off-pump CABG Surgery

Study Overview
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Brief Summary
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This is a Phase 2, multicenter, open-label, single-arm, sequential cohort study to be conducted in up to 30 subjects. The study will evaluate subjects undergoing primary, elective, off-pump CABG surgery with median sternotomy.

Official Title
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Phase 2 Study of NU172 Anticoagulation in Patients Undergoing Coronary Artery Bypass Graft Surgery OFF-Pump

Conditions
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Heart Disease

Intervention / Treatment
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* Drug: NU172


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must give written informed consent prior to initiation of any study related procedures Male or female subjects at least 18 years of age Subject is accepted for primary, elective off-pump CABG surgery with planned sternotomy without other planned concomitant cardiac surgical procedures New York Heart Association (NYHA) Class III or less heart failure Available for follow-up assessments Exclusion Criteria: Prior surgery with median sternotomy Prior CABG surgery Women of childbearing potential who are not using adequate contraceptive precautions (e.g. intrauterine device, oral contraceptives,barrier methods, or other contraception deemed adequate by the investigator); women who are pregnant or lactating Stroke within the previous 6 months History of stroke with residual neurological deficit Intracranial neoplasm, arteriovenous malformation or aneurysm Any prior exposure to NU172 Contraindication to unfractionated heparin Refusal to undergo blood transfusion, should it be necessary Symptomatic gout Serum uric acid >11mg/dL at screening Known bleeding diathesis Known thrombotic diathesis Participation in any study of an investigational device, drug or biologic within 30 days prior to planned surgery Any other disease or condition that, in the judgment of the investigator would interfere with the subject's ability to comply with study procedures and requirements

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: NU172|NU172 administered IV bolus followed by continuous infusion during CABG surgery|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and efficacy of NU172 in patients undergoing off-pump CABG surgery |  | 30 day follow-up visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the pharmacokinetic (PK)profile of NU172 in patients undergoing off-pump CABG surgery |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CABG, anticoagulant, Off-Pump CABG