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

Phase 2

• Conditions: Heart Disease

• Registration Number: NCT00808964
• Lead Sponsor: ARCA Biopharma, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-12
• Study First Submitted QC: 2008-12-15
• Study First Posted: 2008-12-16
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-08
• Last Update Posted: 2011-06-10
• Study Start: 2013-01
• Primary Completion: 2013-06
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety and efficacy of NU172 in patients undergoing off-pump CABG surgery	30 day follow-up visit

Secondary Outcome Measures

Name	Time	Method
Evaluate the pharmacokinetic (PK)profile of NU172 in patients undergoing off-pump CABG surgery	24 hours