Heart DiseasePhase 2SNAP-CABG-OFFNCT00808964
Study of NU172 as Anticoagulation in Patients Undergoing Off-pump CABG Surgery
A Phase 2 study testing NU172 in people with Heart Disease, run by ARCA Biopharma, Inc..
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Disease
- What is being tested?
- NU172
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Sep 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Phase 2 Study of NU172 Anticoagulation in Patients Undergoing Coronary Artery Bypass Graft Surgery OFF-Pump
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.
- Conditions
- Heart Disease
- Being tested
- NU172
- Keywords
- CABG, anticoagulant, Off-Pump CABG
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NU172Drug
NU172 administered IV bolus followed by continuous infusion during CABG surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and efficacy of NU172 in patients undergoing off-pump CABG surgery
Measured: 30 day follow-up visit
Secondary outcomes (1)
Evaluate the pharmacokinetic (PK)profile of NU172 in patients undergoing off-pump CABG surgery
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2008 (estimated)
- Study startJan 2013
- Primary completionJun 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ARCA Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nicholas Smedira, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00808964
- Sponsor's protocol ID
- CLINPRO-303
- Acronym
- SNAP-CABG-OFF
- Status last verified
- Jun 2011
- First submitted
- 12 Dec 2008
- Last updated
- 10 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of NU172 Anticoagulation in Patients Undergoing Coronary Artery Bypass Graft Surgery OFF-Pump
- ClinicalTrials.gov ID
- NCT00808964
- Acronym / sponsor ID
- SNAP-CABG-OFF / CLINPRO-303
- Conditions
- Heart Disease
- Keywords
- CABG, anticoagulant, Off-Pump CABG
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- ARCA Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 16 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NU172NU172 administered IV bolus followed by continuous infusion during CABG surgery | Drug | – |
Primary outcome
Safety and efficacy of NU172 in patients undergoing off-pump CABG surgery
Time frame: 30 day follow-up visit
1 secondary outcome
Evaluate the pharmacokinetic (PK)profile of NU172 in patients undergoing off-pump CABG surgery
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Smedira, M.D. principal investigator
The Cleveland Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NU172 in people with Heart Disease, run by ARCA Biopharma, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Monique Plamondon (720-940-2125, monique.plamondon@arcabiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and efficacy of NU172 in patients undergoing off-pump CABG surgery (time frame: 30 day follow-up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2011.