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Study of NU172 as Anticoagulation in Patients Undergoing Off-Pump CABG Surgery (SNAP-CABG-OFF)
This study is not yet open for participant recruitment.
Verified by ARCA Biopharma, Inc., March 2009
First Received: December 12, 2008   Last Updated: March 19, 2009   History of Changes
Sponsored by: ARCA Biopharma, Inc.
Information provided by: ARCA Biopharma, Inc.
ClinicalTrials.gov Identifier: NCT00808964
  Purpose

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.


Condition Intervention Phase
Heart Disease
Drug: NU172
Phase II

MedlinePlus related topics: Heart Diseases Surgery
U.S. FDA Resources
Study Type: Interventional
Study Design: Non-Randomized, Open Label, Single Group Assignment
Official Title: Phase 2 Study of NU172 Anticoagulation in Patients Undergoing Coronary Artery Bypass Graft Surgery OFF-Pump

Further study details as provided by ARCA Biopharma, Inc.:

Primary Outcome Measures:
  • Safety and efficacy of NU172 in patients undergoing off-pump CABG surgery [ Time Frame: 30 day follow-up visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate the pharmacokinetic (PK)profile of NU172 in patients undergoing off-pump CABG surgery [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2009
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: NU172
    NU172 administered IV bolus followed by continuous infusion during CABG surgery
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00808964

Contacts
Contact: Mark Joing 650-517-8000 mark.joing@arcabiopharma.com

Sponsors and Collaborators
ARCA Biopharma, Inc.
Investigators
Principal Investigator: Nicholas Smedira, M.D. The Cleveland Clinic
  More Information

No publications provided

Responsible Party: ARCA biopharma, Inc. ( Michael Bristow, M.D., PhD )
Study ID Numbers: CLINPRO-303
Study First Received: December 12, 2008
Last Updated: March 19, 2009
ClinicalTrials.gov Identifier: NCT00808964     History of Changes
Health Authority: United States: Food and Drug Administration;   Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by ARCA Biopharma, Inc.:
CABG
anticoagulant
Off-Pump CABG

Study placed in the following topic categories:
Anticoagulants
Heart Diseases

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009