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

June 8, 2011 updated by: ARCA Biopharma, Inc.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ARCA Biopharma, Inc.

Investigators

  • Principal Investigator: Nicholas Smedira, M.D., The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ANTICIPATED)

June 1, 2013

Study Completion (ANTICIPATED)

September 1, 2013

Study Registration Dates

First Submitted

December 12, 2008

First Submitted That Met QC Criteria

December 15, 2008

First Posted (ESTIMATE)

December 16, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 10, 2011

Last Update Submitted That Met QC Criteria

June 8, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLINPRO-303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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