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

• Status: Unknown status
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ARCA Biopharma, Inc.

Criteria

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