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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by ARCA Biopharma, Inc..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
ARCA Biopharma, Inc.
ClinicalTrials.gov Identifier:
NCT00808964
First received: December 12, 2008
Last updated: June 8, 2011
Last verified: June 2011
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
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: January 2013
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808964

Contacts
Contact: Monique Plamondon 720-940-2125 monique.plamondon@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: Michael Bristow, M.D., PhD, ARCA biopharma, Inc.
ClinicalTrials.gov Identifier: NCT00808964     History of Changes
Other Study ID Numbers: CLINPRO-303
Study First Received: December 12, 2008
Last Updated: June 8, 2011
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

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014