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Clinical trials for Direct Thrombin Inhibitor

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
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • 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   43881   clinical trials with a EudraCT protocol, of which   7295   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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    20 result(s) found for: Direct Thrombin Inhibitor. Displaying page 1 of 1.
    EudraCT Number: 2014-000388-41 Sponsor Protocol Number: OZR-2013-27 Start Date*: 2014-05-05
    Sponsor Name:The Rotterdam Eye Hospital
    Full Title: Does oral administration of dabigatran etexilate, a direct thrombin inhibitor, achieve clinical significant concentrations of dabigatran and thrombin inhibiting activity in vitreous and subretinal ...
    Medical condition: Ocular accessibility of dabigatran in patients with retinal detachment
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2012-002263-96 Sponsor Protocol Number: 39486 Start Date*: 2012-07-11
    Sponsor Name:MUMC
    Full Title: dabigatran and rivaroxaban: prediction of anticoagulant effect
    Medical condition: non valvular atrial fibrillation
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-003122-28 Sponsor Protocol Number: ArgLepi-2006 Start Date*: 2008-12-19
    Sponsor Name:Heinrich-Heine-Universität Düsseldorf
    Full Title: Argatroban versus Lepirudin in Critically Ill Patients
    Medical condition: Critically ill patients are usually treated with heparin for anticoagulation. A serious complication of heparin therapy is heparin-induced thrombocytopenia type II (HIT). Patients with HIT have t...
    Disease: Version SOC Term Classification Code Term Level
    8.1 10062506 Heparin-induced thrombocytopenia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2021-000740-21 Sponsor Protocol Number: LEX-210 Start Date*: 2022-04-08
    Sponsor Name:Octapharma AG
    Full Title: Study of four-factor prothrombin complex concentrate, OCTAPLEX, in patients with acute major bleeding on direct oral anticoagulant (DOAC) therapy with factor Xa inhibitor.
    Medical condition: Acute major bleeding in patients receiving DOAC therapy with factor Xa inhibitor
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10009731 Coagulation disorder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing) IT (Ongoing) ES (Ongoing) AT (Ongoing) HR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-018723-26 Sponsor Protocol Number: 1160.86 Start Date*: 2010-07-15
    Sponsor Name:Boehringer Ingelheim Finland Ky
    Full Title: An open label, non-comparative, pharmacokinetic and pharmacodynamic study to evaluate the effect of Dabigatran Etexilate on coagulation parameters including a calibrated thrombin time test in patie...
    Medical condition: Primary VTE prevention in patients with moderate renal impairment (Creatinine Clearance 30-50 ml/min) following total hip or knee replacement surgery
    Disease: Version SOC Term Classification Code Term Level
    12.1 10049909 Venous thromboembolism prophylaxis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) AT (Completed) SE (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2004-000359-41 Sponsor Protocol Number: D1250C00007 Start Date*: 2004-08-31
    Sponsor Name:AstraZeneca AB
    Full Title: A Controlled, Randomised, Parallel, Multicentre Study to Assess Safety and Tolerability of the Oral Direct Thrombin Inhibitor AZD0837 in the Prevention of Stroke and other Thromboembolic Complicati...
    Medical condition: Prevention of stroke and other thromboembolic complications associated with Atrial Fibrillation
    Disease: Version SOC Term Classification Code Term Level
    7.0 10003658 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2015-001785-26 Sponsor Protocol Number: 14-505 Start Date*: 2016-02-15
    Sponsor Name:Portola Pharmaceuticals, Inc.
    Full Title: Prospective, Open-label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor who Have Acute Major Bleeding (ANNEXA-4).
    Medical condition: Uncontrolled bleeding in patients who have taken either a direct factor Xa inhibitor (novel oral anticoagulants) or an indirect factor Xa inhibitor (low molecular weight heparins).
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000022097 10075279 Anticoagulant reversal therapy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) GB (Completed) BE (Completed) DE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2014-000112-33 Sponsor Protocol Number: NL47761.041.14 Start Date*: 2014-09-01
    Sponsor Name:University Medical Center Utrecht
    Full Title: Apixaban versus antiplatelet drugs or no antithrombotic drugs after anticoagulation-associated intracerebral haemorrhage in patients with atrial fibrillation. A randomised phase II clinical trial.
    Medical condition: The prevention of ischaemic stroke in patients with atrial fibrillation
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2018-001495-38 Sponsor Protocol Number: XYN-602 Start Date*: 2019-02-05
    Sponsor Name:Xynomic Pharmaceuticals, Inc.
    Full Title: A Randomized, Phase 3, Double-blind, Placebo-controlled Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma
    Medical condition: Locally Advanced or Metastatic Renal Cell Carcinoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10050513 Metastatic renal cell carcinoma PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10067946 Renal cell carcinoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended) ES (Prematurely Ended) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2004-001674-80 Sponsor Protocol Number: ARG-E04 Start Date*: 2005-06-13
    Sponsor Name:Mitsubishi Pharma Corporation
    Full Title: A Randomised, Open, Parallel Group, Multicentre Study to Examine the Safety and Effectiveness of Three Doses of Argatroban as Anticoagulant in Combination with Clopidogrel and Aspirin in Patients u...
    Medical condition: Stable coronary artery disease (CAD) or unstable angina (troponin negative, i.e. within the normal range for the study site) with low to moderate anatomic risk and a requirement for elective percut...
    Disease: Version SOC Term Classification Code Term Level
    7.1 10011078 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2008-003698-42 Sponsor Protocol Number: D1250C00012 Start Date*: 2008-11-21
    Sponsor Name:AstraZeneca AB
    Full Title: A controlled, randomised, double-blind, double-dummy, parallel-group, phase III, multicenter study to evaluate efficacy and safety of the oral direct thrombin inhibitor AZD0837 compared to warfarin...
    Medical condition: the prevention of stroke and systemic embolic events (SEE) in patients with non-valvular atrial fibrillation (AF)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10003658 Atrial fibrillation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) SK (Ongoing) DE (Completed) HU (Ongoing) ES (Prematurely Ended) FR (Ongoing) DK (Prematurely Ended) BG (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-001722-27 Sponsor Protocol Number: D1250C00042 Start Date*: 2007-10-11
    Sponsor Name:AstraZeneca AB
    Full Title: Long-term treatment with the oral direct thrombin inhibitor AZD0837, compared to Vitamin-K antagonists, as stroke prevention in patients with non-valvular atrial fibrillation and one or more risk f...
    Medical condition: Paroxysmal persistent or permanent non-valvular atrial fibrillation
    Disease: Version SOC Term Classification Code Term Level
    9.1 10003658 Atrial fibrillation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Suspended by CA) DK (Prematurely Ended) SE (Prematurely Ended) AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-009056-20 Sponsor Protocol Number: 1.0 Start Date*: 2010-01-21
    Sponsor Name:MUW, Department of Clinical Pharmacology
    Full Title: Does staphylothrombin enhance coagulation activation in staphylococcus aureus bacteremia?
    Medical condition: Patients with staphylococci bacteremia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10054637 Staphylococcal bacteremia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2007-007536-25 Sponsor Protocol Number: 1160.73 Start Date*: 2008-08-26
    Sponsor Name:Boehringer Ingelheim b.v.
    Full Title: Randomized, Open-label study of Dabigatran Etexilate, a Novel, oral, Direct Thrombin-inhibitor in clinical development, in Elective Percutaneous Coronary Intervention. (D-Fine)
    Medical condition: Acute Coronary Syndrome
    Disease: Version SOC Term Classification Code Term Level
    9.1 10051592 Acute coronary syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2007-002586-12 Sponsor Protocol Number: 1160.63 Start Date*: Information not available in EudraCT
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: Twice-daily oral direct thrombin inhibitor dabigatran in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embo...
    Medical condition: long-term prevention of recurrent symptomatic venous thromboembolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed 6 to 18 months of treatme...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10049909 Venous thromboembolism prophylaxis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) SE (Completed) AT (Completed) IT (Completed) PL (Completed) CZ (Completed) NL (Completed) BE (Completed) LT (Completed) LV (Completed) EE (Completed)
    Trial results: View results
    EudraCT Number: 2006-005437-38 Sponsor Protocol Number: D1250C00008 Start Date*: 2007-03-07
    Sponsor Name:AstraZeneca AB
    Full Title: A Controlled, Randomized, Parallel, Multicentre Study to Assess Safety and Tolerability of the Oral Direct Thrombin Inhibitor AZD0837, given as an Extended-release Formulation, in the Prevention of...
    Medical condition: Paroxysmal, persistent or permanent nonvalvular atrial fibrillation
    Disease: Version SOC Term Classification Code Term Level
    8.1 10003658 Atrial fibrillation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) SE (Completed) HU (Completed) AT (Completed) DK (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2004-002171-16 Sponsor Protocol Number: BAY 59-7939 / 11528 Start Date*: 2005-01-10
    Sponsor Name:Bayer HealthCare AG
    Full Title: Once-daily oral Direct Factor Xa Inhibitor BAY 59-7939 in Patients with acute symptomatic Deep Vein Thrombosis. The Einstein-DVT dose-finding study.
    Medical condition: Acute syntomatic deep vein thrombosis
    Disease: Version SOC Term Classification Code Term Level
    7.0 10051055
    Population Age: Gender: Male, Female
    Trial protocol: SE (Completed) DK (Completed) CZ (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-006056-37 Sponsor Protocol Number: 1160.143 Start Date*: 2013-09-05
    Sponsor Name:Hamilton Health Sciences Corporation
    Full Title: A large, international, randomized, placebo-controlled trial to assess the impact of dabigatran (a direct thrombin inhibitor) and omeprazole (a proton-pump inhibitor) in patients suffering myocardi...
    Medical condition: MINS (myocardial injury after noncardiac surgery)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10022117 - Injury, poisoning and procedural complications 10066592 Post procedural myocardial infarction PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) IT (Completed) PT (Completed) ES (Completed) GB (Completed) AT (Completed) DE (Prematurely Ended) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2004-001083-43 Sponsor Protocol Number: BAY 59-7939 / 11223 Start Date*: 2004-11-23
    Sponsor Name:Bayer HealthCare AG
    Full Title: Oral Direct Factor Xa Inhibitor BAY 59-7939 in Patients with acute symptomatic Deep Vein Thrombosis ODIXa-DVT A prospective, randomized, multinational, multicenter, partially blinded, parallel-grou...
    Medical condition: Acute deep vein thrombosis
    Disease: Version SOC Term Classification Code Term Level
    7.0 10051055 Code
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2007-001723-36 Sponsor Protocol Number: D1250C0051 Start Date*: 2007-10-16
    Sponsor Name:AstraZeneca AB
    Full Title: A controlled, randomized, parallel, multi-centre, feasibility study of the oral direct thrombin inhibitor AZD0837, given as extended-release formulation, in the prevention of stroke and systemic em...
    Medical condition: This is a phase II study to evaluate the feasibility of conducting a study in patients with AF who are appropriate for, but unable or unwilling to take VKA therapy. The intended indication for th...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10003658 Atrial fibrillation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) GB (Completed) DK (Completed)
    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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