Study of NU172 as Anticoagulation in Patients Undergoing Off-pump CABG Surgery
SNAP-CABG-OFF
Phase 2 Study of NU172 Anticoagulation in Patients Undergoing Coronary Artery Bypass Graft Surgery OFF-Pump
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2013
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2008
CompletedFirst Posted
Study publicly available on registry
December 16, 2008
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedJune 10, 2011
June 1, 2011
5 months
December 12, 2008
June 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and efficacy of NU172 in patients undergoing off-pump CABG surgery
30 day follow-up visit
Secondary Outcomes (1)
Evaluate the pharmacokinetic (PK)profile of NU172 in patients undergoing off-pump CABG surgery
24 hours
Interventions
NU172 administered IV bolus followed by continuous infusion during CABG surgery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicholas Smedira, M.D.
The Cleveland Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 12, 2008
First Posted
December 16, 2008
Study Start
January 1, 2013
Primary Completion
June 1, 2013
Study Completion
September 1, 2013
Last Updated
June 10, 2011
Record last verified: 2011-06