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Last Updated: November 25, 2024

CLINICAL TRIALS PROFILE FOR AMICAR


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All Clinical Trials for AMICAR

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00223704 ↗ Bradykinin Receptor Antagonism During Cardiopulmonary Bypass Completed Vanderbilt University Phase 2/Phase 3 2006-05-01 Each year over a million patients worldwide undergo cardiac surgery requiring cardiopulmonary bypass (CPB). CPB is associated with significant morbidity including the transfusion of allogenic blood products, inflammation and hemodynamic instability. In fact, approximately 20% of all blood products transfused are associated with coronary artery bypass grafting procedures. Transfusion of allogenic blood products is associated with well-documented morbidity and increased mortality after cardiac surgery. Enhanced fibrinolysis contributes to increased blood product transfusion in the perioperative period. The current proposal tests the central hypothesis that endogenous bradykinin contributes to the hemodynamic, fibrinolytic and inflammatory response to CPB and that bradykinin receptor antagonism will reduce hypotension, inflammation and transfusion requirements. In SPECIFIC AIM 1 we will test the hypothesis that the fibrinolytic and inflammatory response to CPB differ during ACE inhibition and angiotensin II type 1 receptor antagonism. In SPECIFIC AIM 2 we will test the hypothesis that bradykinin B2 receptor antagonism attenuates the hemodynamic, fibrinolytic, and inflammatory response to CPB. In SPECIFIC AIM 3 we will test the hypothesis that bradykinin B2 receptor antagonism reduces the risk of allogenic blood product transfusion in patients undergoing CPB. These studies promise to provide important information regarding the effects of drugs that interrupt the RAS and generate new strategies to reduce morbidity in patients undergoing CPB.
NCT00223704 ↗ Bradykinin Receptor Antagonism During Cardiopulmonary Bypass Completed Vanderbilt University Medical Center Phase 2/Phase 3 2006-05-01 Each year over a million patients worldwide undergo cardiac surgery requiring cardiopulmonary bypass (CPB). CPB is associated with significant morbidity including the transfusion of allogenic blood products, inflammation and hemodynamic instability. In fact, approximately 20% of all blood products transfused are associated with coronary artery bypass grafting procedures. Transfusion of allogenic blood products is associated with well-documented morbidity and increased mortality after cardiac surgery. Enhanced fibrinolysis contributes to increased blood product transfusion in the perioperative period. The current proposal tests the central hypothesis that endogenous bradykinin contributes to the hemodynamic, fibrinolytic and inflammatory response to CPB and that bradykinin receptor antagonism will reduce hypotension, inflammation and transfusion requirements. In SPECIFIC AIM 1 we will test the hypothesis that the fibrinolytic and inflammatory response to CPB differ during ACE inhibition and angiotensin II type 1 receptor antagonism. In SPECIFIC AIM 2 we will test the hypothesis that bradykinin B2 receptor antagonism attenuates the hemodynamic, fibrinolytic, and inflammatory response to CPB. In SPECIFIC AIM 3 we will test the hypothesis that bradykinin B2 receptor antagonism reduces the risk of allogenic blood product transfusion in patients undergoing CPB. These studies promise to provide important information regarding the effects of drugs that interrupt the RAS and generate new strategies to reduce morbidity in patients undergoing CPB.
NCT00617955 ↗ Effects of Aprotinin During Cardiac Surgery/Long Term Death Rates Completed State University of New York - Upstate Medical University 2007-09-01 The dept. of Anesthesiology currently has a database of subjects whom had surgery and received either Aprotinin or Amicar in the OR. The current viewpoint is that Aprotinin is more harmful than Amicard. In an effort to see what the long term outcomes were for subjects whom had surgery here at Upstate, it was decided to look at long term death rates to see if any differences. A student t-test will be used to determine statistical significance where a p value of <0.05 will be deemed significant. Using data from 462 subjects that had undergone cardiac surgery at SUNY Upstate Medical University, CABG only and the long term mortality rate from the Mangano, et.al. publications, the unadjusted mortality for the two drugs are Aprotinin 5.4% and Amicar 1.2%. A power analysis was performed using the hospital mortality rates of 5.4% and 1.2% with the sample size in the propensity data and a p-value of 0.05. The result was a power of 81.7%.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for AMICAR

Condition Name

Condition Name for AMICAR
Intervention Trials
Blood Loss 2
Cardiopulmonary Bypass 2
Craniosynostosis 2
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Condition MeSH

Condition MeSH for AMICAR
Intervention Trials
Hemorrhage 2
Osteoarthritis 2
Craniosynostoses 2
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Clinical Trial Locations for AMICAR

Trials by Country

Trials by Country for AMICAR
Location Trials
United States 11
Mexico 1
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Trials by US State

Trials by US State for AMICAR
Location Trials
California 2
Pennsylvania 2
Tennessee 2
District of Columbia 1
Georgia 1
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Clinical Trial Progress for AMICAR

Clinical Trial Phase

Clinical Trial Phase for AMICAR
Clinical Trial Phase Trials
Phase 4 3
Phase 2/Phase 3 1
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for AMICAR
Clinical Trial Phase Trials
Completed 8
Active, not recruiting 1
Withdrawn 1
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Clinical Trial Sponsors for AMICAR

Sponsor Name

Sponsor Name for AMICAR
Sponsor Trials
University of Pennsylvania 1
Vanderbilt University 1
Stanford University 1
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Sponsor Type

Sponsor Type for AMICAR
Sponsor Trials
Other 19
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