CClinicalTrials.gg
Status unknownNCT00808964SNAP-CABG-OFFUpdated Jun 10, 2011

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

A Phase 2 interventional study of NU172 in Heart Disease, sponsored by ARCA Biopharma, Inc.. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-06-10.

Sponsored by ARCA Biopharma, Inc. · Phase 2 and Interventional

The sponsor has not verified this record recently (last verified Jun 2011), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Heart Disease

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Keywords

  • CABG
  • anticoagulant
  • Off-Pump CABG
03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's planned enrollment of 30 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

ARCA Biopharma, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Interventions

  • DrugNU172

    NU172 administered IV bolus followed by continuous infusion during CABG surgery

06

What researchers measure

Primary outcomes

  1. Safety and efficacy of NU172 in patients undergoing off-pump CABG surgery

    Time frame: 30 day follow-up visit

Secondary outcomes

  1. Evaluate the pharmacokinetic (PK)profile of NU172 in patients undergoing off-pump CABG surgery

    Time frame: 24 hours

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00808964
Lead sponsor
ARCA Biopharma, Inc.
First posted
Dec 16, 2008
Start date
Jan 2013
Primary completion
Jun 2013 (estimated)
Completion
Sep 2013 (estimated)
Last update
Jun 10, 2011

Study contacts

Monique Plamondon
Contact
monique.plamondon@arcabiopharma.com
720-940-2125
Nicholas Smedira, M.D.
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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