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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00808964

Acronym

SNAP-CABG-OFF

Enrollment

Registered

2008-12-16

Start date

2013-01-31

Completion date

2013-09-30

Last updated

2011-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Disease

Keywords

CABG, anticoagulant, Off-Pump CABG

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.

Interventions

DRUGNU172

NU172 administered IV bolus followed by continuous infusion during CABG surgery

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Contacts

Primary ContactMonique Plamondon

monique.plamondon@arcabiopharma.com720-940-2125

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026