Bivalirudin

Generic Name: Bivalirudin

Brand Names: Angiomax

Drug Type: Small Molecule

Chemical Formula: C_₉₈H_₁₃₈N_₂₄O_₃₃

CAS Number: 128270-60-0

Unique Ingredient Identifier: TN9BEX005G

Background: Bivalirudin is a synthetic 20 residue peptide (thrombin inhibitor) which reversibly inhibits thrombin. Once bound to the active site, thrombin cannot activate fibrinogen into fibrin, the crucial step in the formation of thrombus. It is administered intravenously. Because it can cause blood stagnation, it is important to monitor changes in hematocrit, activated partial thromboplastin time, international normalized ratio and blood pressure.

Indication: For treatment of heparin-induced thrombocytopenia and for the prevention of thrombosis. Bivalirudin is indicated for use in patients undergoing percutaneous coronary intervention (PCI), in patients at moderate to high risk acute coronary syndromes due to unstable angina or non-ST segment elevation in whom a PCI is planned.

Associated Conditions: Thrombosis

Clinical Trials

Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation

Recruiting

Conditions: Drug Effect

Interventions: Drug: Bivalirudin

First Posted Date: 2018-05-22

Last Posted Date: 2024-06-14

Lead Sponsor: Boston Children's Hospital

Target Recruit Count: 30

Registration Number: NCT03532399

Locations: 🇺🇸
Boston Children's Hospital, Boston, Massachusetts, United States

Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO

Phase 4

Completed

Conditions: Anticoagulants
Pediatric ALL
Extracorporeal Membrane Oxygenation Complication

Interventions: Drug: Bivalirudin
Drug: Unfractionated heparin

First Posted Date: 2017-10-23

Last Posted Date: 2023-01-31

Lead Sponsor: University of Texas Southwestern Medical Center

Target Recruit Count: 30

Registration Number: NCT03318393

Locations: 🇺🇸
Children's Medical Center, Dallas, Texas, United States

Bivalirudin in Acute Myocardial Infarction

Phase 3

Conditions: Acute Myocardial Infarction

Interventions: Drug: Bivalirudin
Drug: heparin

First Posted Date: 2016-09-12

Last Posted Date: 2016-11-28

Lead Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.

Target Recruit Count: 380

Registration Number: NCT02897037

Locations: 🇨🇳
Department of Cardiology，General Hospital of Shenyang Military Region, Shanyang, Liaoning, China

Bivalirudin in Stable Ischemic Heart Disease Patients Undergoing PCI

Phase 4

Conditions: Coronary Disease

Interventions: Drug: bivalirudin
Drug: Heparin

First Posted Date: 2016-06-01

Last Posted Date: 2016-06-01

Lead Sponsor: Chinese PLA General Hospital

Target Recruit Count: 1770

Registration Number: NCT02787317

Locations: 🇨🇳
ChinaPLAGH, Beijing, Beijing, China

Bivalirudin Infusion for Ventricular Infarction Limitation

Phase 3

Terminated

Conditions: Acute Myocardial Infarction

Interventions: Procedure: PPCI
Drug: Bivalirudin
Drug: Heparin

First Posted Date: 2015-10-01

Last Posted Date: 2018-10-05

Lead Sponsor: The Medicines Company

Target Recruit Count: 78

Registration Number: NCT02565147

Locations: 🇫🇷
Hopital Ambroise Paré, Boulogne Cedex, France
🇫🇷
Hospital Lariboisière, Paris, France
🇳🇱
VUMC Amsterdam, Amsterdam, Netherlands

and more 1 locations

Comparison of Anticoagulation for All-comers Undergoing Percutaneous Coronary Revascularization Trial

Phase 3

Terminated

Conditions: Percutaneous Coronary Intervention

Interventions: Drug: Unfractionated heparin
Drug: Bivalirudin

First Posted Date: 2015-05-19

Last Posted Date: 2018-05-24

Lead Sponsor: Kaiser Permanente

Target Recruit Count: 250

Registration Number: NCT02448550

Locations: 🇺🇸
Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States

Simplified Anti-Thrombotic Therapy for FFR

Not Applicable

Completed

Conditions: Coronary Artery Disease

Interventions: Procedure: FFR
Drug: Aspirin
Drug: Clopidogrel
Drug: Bivalirudin

First Posted Date: 2015-03-10

Last Posted Date: 2017-02-03

Lead Sponsor: Odessa Heart Institute

Target Recruit Count: 300

Registration Number: NCT02384070

Bivalirudin vs Heparin in NSTEMI and STEMI in Patients on Modern Antiplatelet Therapy in SWEDEHEART

Phase 4

Completed

Conditions: ST-segment Elevation Myocardial Infarction
Non ST-segment Elevation Myocardial Infarction

Interventions: Drug: Heparin
Drug: bivalirudin

First Posted Date: 2014-12-08

Last Posted Date: 2017-05-19

Lead Sponsor: Uppsala University

Target Recruit Count: 6012

Registration Number: NCT02311231

Locations: 🇸🇪
Lund University, Lund, Sweden

ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial

Phase 3

Terminated

Conditions: Peripheral Endovascular Interventions
Bleeding

Interventions: Drug: Bivalirudin
Drug: Unfractionated Heparin

First Posted Date: 2013-08-01

Last Posted Date: 2017-05-30

Lead Sponsor: The Medicines Company

Target Recruit Count: 732

Registration Number: NCT01913483

Locations: 🇺🇸
Clearwater Cardiovascular and Interventional Consultants, Clearwater, Florida, United States
🇺🇸
Deborah Heart and Lung Center, Browns Mills, New Jersey, United States
🇺🇸
Stony Brook Medicine, Stony Brook, New York, United States

and more 36 locations

Effects Contrast on Platelet Activity, Thrombosis and Fibrinolysis in Patients Undergoing Coronary Angiography

Phase 4

Completed

Conditions: Coronary Artery Disease

Interventions: Drug: Ioxaglate
Drug: Iodixanol
Drug: Bivalirudin

First Posted Date: 2013-05-08

Last Posted Date: 2016-04-06

Lead Sponsor: NYU Langone Health

Target Recruit Count: 100

Registration Number: NCT01848899

Locations: 🇺🇸
New York University School of Medicine, New York, New York, United States

Drug Development Updates

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