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

NCT ID: NCT00808964

Last Updated: 2011-06-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-09-30

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.

Conditions

Heart Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Interventions

NU172

NU172 administered IV bolus followed by continuous infusion during CABG surgery

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ARCA Biopharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

ARCA biopharma, Inc.

Principal Investigators

Nicholas Smedira, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Central Contacts

Monique Plamondon

Role: CONTACT

monique.plamondon@arcabiopharma.com

720-940-2125

Other Identifiers

CLINPRO-303

Identifier Type: -

Identifier Source: org_study_id