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Sponsored by: |
ARCA Biopharma, Inc. |
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Information provided by: | ARCA Biopharma, Inc. |
ClinicalTrials.gov Identifier: | NCT00808964 |
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 |
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Heart Disease |
Drug: NU172 |
Phase II |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Single Group Assignment |
Official Title: | Phase 2 Study of NU172 Anticoagulation in Patients Undergoing Coronary Artery Bypass Graft Surgery OFF-Pump |
Estimated Enrollment: | 30 |
Study Start Date: | September 2009 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mark Joing | 650-517-8000 | mark.joing@arcabiopharma.com |
Principal Investigator: | Nicholas Smedira, M.D. | The Cleveland Clinic |
Responsible Party: | ARCA biopharma, Inc. ( Michael Bristow, M.D., PhD ) |
Study ID Numbers: | CLINPRO-303 |
Study First Received: | December 12, 2008 |
Last Updated: | March 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00808964 History of Changes |
Health Authority: | United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices |
CABG anticoagulant Off-Pump CABG |
Anticoagulants Heart Diseases |
Heart Diseases Cardiovascular Diseases |