Study of NU172 as Anticoagulation in Patients Undergoing Off-pump CABG Surgery (SNAP-CABG-OFF)

ARCA Biopharma

Status and phase: Unknown; Phase 2

Conditions: Heart Disease

Treatments: Drug: NU172

Study type: Interventional

Funder types: Industry

Identifiers

NCT00808964

CLINPRO-303

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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