Status:
UNKNOWN
Study of NU172 as Anticoagulation in Patients Undergoing Off-pump CABG Surgery
Lead Sponsor:
ARCA Biopharma, Inc.
Conditions:
Heart Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 surge...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00808964
Start Date
January 1 2013
End Date
September 1 2013
Last Update
June 10 2011
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