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Clinical trials for Bivalirudin

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    25 result(s) found for: Bivalirudin. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2005-003053-26 Sponsor Protocol Number: TMC-BIV-05-01 Start Date*: 2005-12-08
    Sponsor Name:The Medicines Company UK Ltd
    Full Title: The ZBMUF trial: an open-label randomised study of the effects of ultra-filtration and high dose aprotinin on bivalirudin pharmacokinetics during and/or after cardiopulmonary bypass surgery
    Medical condition: This trial will involve approximately 42 patients requiring coronary artery bypass graft surgery (CABG).
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2010-023779-24 Sponsor Protocol Number: M10-1028 Start Date*: 2010-12-06
    Sponsor Name:Stichting Toegepast Caridologisch Onderzoek
    Full Title: A Comparison of Drug Eluting and Bare Metal Stents with Bivalirudin during PCI or Bivalirudin for 4 hours in Acute Coronary Syndromes. The Eindhoven Reperfusion Study
    Medical condition: Patients with ACS who are scheduled for primary PCI (STEMI) or for immediate PCI < 2.5 hours or early PCI < 48 hours (NSTEMI) and who are pre-treated with HLD clopidogrel
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-001384-23 Sponsor Protocol Number: REG1-CLIN310 Start Date*: 2013-10-30
    Sponsor Name:Regado Biosciences, Inc.
    Full Title: A RANDOMIZED, OPEN-LABEL, MULTI-CENTER, ACTIVE-CONTROLLED, PARALLEL GROUP STUDY TO DETERMINE THE EFFICACY AND SAFETY OF THE REG1 ANTICOAGULATION SYSTEM COMPARED TO BIVALIRUDIN IN PATIENTS UNDERGOIN...
    Medical condition: Coronary Artery Disease (CAD) in patients undergoing Percutaneous Coronary Intervention (PCI)
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004849 10011085 Ischaemic coronary artery disorders HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) EE (Prematurely Ended) DE (Prematurely Ended) NL (Completed) PT (Prematurely Ended) AT (Completed) GB (Completed) IT (Prematurely Ended) BE (Completed) SK (Prematurely Ended) ES (Prematurely Ended) DK (Prematurely Ended) PL (Prematurely Ended) CZ (Prematurely Ended) FR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-001514-41 Sponsor Protocol Number: G040188 Start Date*: 2005-07-06
    Sponsor Name:The Cardiovascular Research Foundation
    Full Title: A dual arm factorial randomized trial in patients with ST segment elevation AMI to compare the results of using either anticoagulation with unfractionated heparin plus routine GP IIb/IIIa inhibitio...
    Medical condition: The medical condition for this clinical trial is Acute Myocardial Infarction (AMI). AMI is defined as death or necrosis of myocardial cells. It is a diagnosis at the end of the spectrum of myocardi...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) SE (Prematurely Ended) ES (Completed) DE (Completed) GB (Completed) DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-000632-26 Sponsor Protocol Number: TMC-BIV-11-02 Start Date*: 2013-03-22
    Sponsor Name:The Medicines Company
    Full Title: Effect of Bivalirudin on Aortic Valve Intervention Outcomes 2/3
    Medical condition: Patients undergoing transcatheter aortic valve replacement (TAVR) procedures performed via the transfemoral approach.
    Disease: Version SOC Term Classification Code Term Level
    17.0 10042613 - Surgical and medical procedures 10002916 Aortic valve replacement PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2005-003013-32 Sponsor Protocol Number: GE IDE No. A01005 Start Date*: 2005-11-08
    Sponsor Name:Deutsches Herzzentrum München
    Full Title: PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED; MULTICENTER TRIAL OF BIVALIRUDIN AND UN-FRACTIONATED HEPARIN IN PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTIONS
    Medical condition: Coronary Artery Disease
    Disease: Version SOC Term Classification Code Term Level
    8.1 10011099 Coronary disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2006-002085-19 Sponsor Protocol Number: GE IDE NO. A01106 Start Date*: Information not available in EudraCT
    Sponsor Name:Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München
    Full Title: PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, MULTICENTER TRIAL OF ABCIXIMAB AND BIVALIRUDIN IN PATIENTS WITH NON-ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION UNDERGOING PERCUTANEOUS CORO...
    Medical condition: Acute Coronary Syndrome
    Disease: Version SOC Term Classification Code Term Level
    8.1 10051592 Acute coronary syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2011-005273-23 Sponsor Protocol Number: 923 Start Date*: 2012-01-30
    Sponsor Name:Liverpool Heart and Chest Hospital
    Full Title: HEAT-PPCI - How Effective are Antithrombotic Therapies in Primary Percutaneous Coronary Intervention - A randomised controlled trial to compare unfractionated heparin versus bivalirudin in the trea...
    Medical condition: ST elevation myocardial infarction
    Disease: Version SOC Term Classification Code Term Level
    14.0 10007541 - Cardiac disorders 10000891 Acute myocardial infarction PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-014343-36 Sponsor Protocol Number: GE IDE NO. I01209 Start Date*: 2009-09-09
    Sponsor Name:Deutsches Herzzentrum
    Full Title: RANDOMIZED TRIAL OF PRASUGREL PLUS BIVALIRUDIN VERSUS CLOPIDOGREL PLUS HEPARIN IN PATIENTS WITH ACUTE STEMI BAVARIAN REPERFUSION ALTERNATIVES EVALUATION [BRAVE-4] TRIAL
    Medical condition: Acute myocardial infarction
    Disease: Version SOC Term Classification Code Term Level
    12.0 10000891 Acute myocardial infarction LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-002314-39 Sponsor Protocol Number: MDCO-BIV-12-02 Start Date*: 2014-07-21
    Sponsor Name:The Medicines Company
    Full Title: Bivalirudin Infusion for Ventricular Infarction Limitation
    Medical condition: Patients presenting with a primary Percutaneous Coronary Intervention for a large acute myocardial infarction -ST elevation myocardial infarction (STEMI).
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004849 10000929 Acute myocardial infarction, unspecified site, episode of care unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-000430-11 Sponsor Protocol Number: RFBU11-I Start Date*: 2011-10-06
    Sponsor Name:G.I.S.E. - SOCIETA'' ITALIANA CARDIOLOGIA INVASIVA
    Full Title: Minimizing Adverse haemmhorragic events by TRansradial access site and systemic Implementation of angioX (MATRIX)
    Medical condition: Real world ACS both Non-ST segment elevation and ST-segment elevation patients undergoing coronary angiography±PCI.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10007541 - Cardiac disorders 10051592 Acute coronary syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing) NL (Ongoing) SE (Ongoing) ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-005260-10 Sponsor Protocol Number: 123 Start Date*: 2013-02-11
    Sponsor Name:Uppsala Clinical Research Center
    Full Title: Bivalirudin versus Heparin in NST and ST-Evaluation myocardial infarction on modern antiplatelet therapy in SWEDEHEART (the VALIDATE - SWEDEHEART-trial)
    Medical condition: Patients with STEMI and NSTEMI treated with PCI and either Bivalirudin (optional to add up to 3000U heparin in lab or up to 5000U given prehospital ) compared to Heparin 70 - 100U/kg alone
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004849 10064347 Non ST segment elevation myocardial infarction LLT
    17.1 100000004849 10064345 ST segment elevation myocardial infarction LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2008-007290-20 Sponsor Protocol Number: TMC-BIV-08-03 Start Date*: Information not available in EudraCT
    Sponsor Name:The Medicines Company UK Ltd.
    Full Title: European Ambulance Acute Coronary Syndrome Angiox Trial: EUROMAX
    Medical condition: Patients presenting with ST-Segment Elevation Acute Coronary Syndrome (STE-ACS) planned for a primary Percutaneous Coronary Intervention (PCI) management strategy
    Disease: Version SOC Term Classification Code Term Level
    14.1 10007541 - Cardiac disorders 10051592 Acute coronary syndrome PT
    14.1 100000004848 10041894 ST segment elevation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) DK (Completed) FR (Completed) NL (Completed) CZ (Completed) ES (Completed) PL (Completed) IT (Completed) SI (Completed)
    Trial results: View results
    EudraCT Number: 2012-003515-58 Sponsor Protocol Number: ECRI-12-001 Start Date*: 2013-05-25
    Sponsor Name:ECRI
    Full Title: GLOBAL LEADERS: Comparative effectiveness of 1 month of ticagrelor plus aspirin followed by ticagrelor monotherapy versus a current-day intensive dual antiplatelet therapy in all-comers patients un...
    Medical condition: Subjects either male or female eligible for percutaneous coronary intervention (PCI) with lesions suitable for stent implantation who meet all eligibility criteria and provide written informed cons...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10007541 - Cardiac disorders 10011078 Coronary artery disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) DE (Completed) GB (Completed) AT (Completed) ES (Completed) BE (Completed) NL (Completed) DK (Completed) HU (Completed) PT (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2014-002514-23 Sponsor Protocol Number: Car20130917 Start Date*: 2015-01-07
    Sponsor Name:VU Medical Center
    Full Title: Reduction Of Microvascular Injury Utilizing Sonolysis
    Medical condition: Myocardial infarction
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-001952-20 Sponsor Protocol Number: NCT:01555658 Start Date*: 2012-12-14
    Sponsor Name:AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
    Full Title: BIVALIRUDIN PLUS STENTING IN lONG LESION TO AVOID PERIPROCEDURAL MYOCARDIAL NECROSIS TRIAL. BILLION TRIAL
    Medical condition: patients with coronary artery disease after stent implantation in coronary long lesions (>25 mm) and undergoing non urgent percutaneous coronary intervention.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10007541 - Cardiac disorders 10011089 Coronary artery stenosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-010903-98 Sponsor Protocol Number: DES 09-01 Start Date*: 2009-08-20
    Sponsor Name:Canyon Pharmaceuticals, Inc.
    Full Title: A dose-ranging study of bolus-only Desirudin in patients undergoing PCI
    Medical condition: Patients due to undergo an elective (non-urgent) PCI on one or multiple lesions in the native coronary vessel(s) via a femoral approach.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-013425-42 Sponsor Protocol Number: 901 Start Date*: 2009-08-14
    Sponsor Name:Atrium Medical Corporation [...]
    1. Atrium Medical Corporation
    2. Cardiovascular Research Foundation
    Full Title: A 2x2 Factorial, Randomized, Multicenter, Single-Blind Evaluation of Intracoronary Abciximab Infusion and Aspiration Thrombectomy in Patients Undergoing Percutaneous Coronary Intervention for Anter...
    Medical condition: The study population will consist of up to 452 male and female subjects with anterior STEMI and occluded proximal or mid LAD with TIMI 0/1 flow with indication for primary PCI.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10000891 Acute myocardial infarction LLT
    9.1 10000904 Acute myocardial infarction, of other anterior wall LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed) AT (Completed) GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-006611-23 Sponsor Protocol Number: MO21609 Start Date*: 2008-10-27
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: Open-label, single-arm, phase II study of bevacizumab (AVASTIN®) in combination with low-dose interferon as first-line treatment of nephrectomised patients with metastatic clear cell renal cell car...
    Medical condition: Metastatic renal cell carcinoma
    Disease: Version SOC Term Classification Code Term Level
    9.1 10050513 Metastatic renal cell carcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: EE (Completed) LT (Completed) CZ (Completed) NL (Completed) PT (Completed) GB (Completed) FI (Completed) SE (Completed) DE (Completed) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2008-004997-41 Sponsor Protocol Number: H7T-MC-TACW Start Date*: Information not available in EudraCT
    Sponsor Name:Eli Lilly and Company
    Full Title: Effectiveness of Prasugrel versus Clopidogrel in Subjects with High Platelet Reactivity on Clopidogrel Following Elective Percutaneous Coronary Intervention with Implantation of Drug-Eluting Stent
    Medical condition: Reduction of composite cardio-vascular end-point in patients who have successfully undergone elective percutaneous coronary intervention with placement of at least one drug-eluting stent.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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