Study of NU172 as Anticoagulation in Patients Undergoing Off-pump CABG Surgery

Heart Disease Clinical Trial

— SNAP-CABG-OFF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00808964
• Other study ID #: CLINPRO-303
• Status: Not yet recruiting
• Phase: Phase 2
• First received: December 12, 2008
• Last updated: June 8, 2011
• Start date: January 2013
• Est. completion date: September 2013

Study information

• Verified date: June 2011
• Source: ARCA Biopharma, Inc.
• Contact: Monique Plamondon
• Phone: 720-940-2125
• Email: monique.plamondon[@]arcabiopharma.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Heart Disease

Intervention

Drug:
• NU172
NU172 administered IV bolus followed by continuous infusion during CABG surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ARCA Biopharma, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and efficacy of NU172 in patients undergoing off-pump CABG surgery		30 day follow-up visit	Yes
Secondary	Evaluate the pharmacokinetic (PK)profile of NU172 in patients undergoing off-pump CABG surgery		24 hours	No