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Clinical trials for Direct Xa 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   44379   clinical trials with a EudraCT protocol, of which   7391   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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    18 result(s) found for: Direct Xa Inhibitor. Displaying page 1 of 1.
    EudraCT Number: 2021-004138-12 Sponsor Protocol Number: TAK-330-3001 Start Date*: 2022-04-11
    Sponsor Name:Takeda Development Center Americas, Inc.
    Full Title: A Phase 3, Prospective, Randomized, Open-label, Adaptive Group Sequential, Multicenter Trial with Blinded Endpoint Assessment to Evaluate the Efficacy and Safety of PROTHROMPLEX TOTAL for the Rever...
    Medical condition: Patients on treatment with Factor Xa Inhibitor needing for an urgent intervention associated with a high risk of bleeding.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004865 10075279 Anticoagulant reversal therapy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) DE (Trial now transitioned) BE (Trial now transitioned) AT (Trial now transitioned) NL (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    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 10005329 - Blood and lymphatic system disorders 10009731 Coagulation disorder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing) AT (Trial now transitioned) HR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-002620-17 Sponsor Protocol Number: 18-513 Start Date*: 2019-01-08
    Sponsor Name:Portola Pharmaceuticals, Inc
    Full Title: A PHASE 4 RANDOMIZED CLINICAL TRIAL OF ANDEXANET ALFA [ANDEXANET ALFA FOR INJECTION] IN ACUTE INTRACRANIAL HEMORRHAGE IN PATIENTS RECEIVING AN ORAL FACTOR XA INHIBITOR
    Medical condition: Oral FXa inhibitor-treated patients with acute intracranial bleeding.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004865 10075279 Anticoagulant reversal therapy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) DE (Completed) GB (GB - no longer in EU/EEA) AT (Completed) BE (Completed) NL (Completed) ES (Prematurely Ended) GR (Completed) CZ (Completed) LV (Completed) FI (Prematurely Ended) NO (Prematurely Ended) LT (Prematurely Ended) PL (Completed) PT (Prematurely Ended) DK (Prematurely Ended) IT (Prematurely Ended) HU (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-002138-35 Sponsor Protocol Number: MEDEA Start Date*: 2019-11-12
    Sponsor Name:Amsterdam University Medical Centers - location AMC
    Full Title: Heavy menstrual bleeding in premenopausal women treated with direct oral anticoagulants - the MEDEA study
    Medical condition: Heavy menstrual bleeding associated with direct oral anticoagulants in premenopausal women.
    Disease: Version SOC Term Classification Code Term Level
    24.0 100000004872 10027313 Menorrhagia LLT
    20.0 10042613 - Surgical and medical procedures 10053468 Anticoagulant therapy PT
    Population Age: Adults Gender: Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    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: 2006-004494-96 Sponsor Protocol Number: BAY 59-7939/IMP 11899 Start Date*: 2007-03-19
    Sponsor Name:Bayer HealthCare AG
    Full Title: Once-daily oral direct factor Xa inhibitor rivaroxaban in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary emb...
    Medical condition: Long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) ES (Completed) SE (Completed) DE (Completed) FI (Completed) FR (Completed) HU (Completed) AT (Completed) IT (Completed) DK (Completed) CZ (Completed) NL (Completed) GB (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: 2005-001388-71 Sponsor Protocol Number: CV185-017 Start Date*: 2005-11-30
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 2 Randomized, Parallel-Arm Study of Oral Direct Factor Xa-Inhibitor Apixaban and Low Molecular Weight Heparin or Fondaparinux With A Vitamin K Antagonist In Subjects With Acute Symptomatic ...
    Medical condition: Acute Symptomatic Deep Vein Thrombosis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) AT (Completed) CZ (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-002442-45 Sponsor Protocol Number: AXAFA-AFNET5 Start Date*: Information not available in EudraCT
    Sponsor Name:Kompetenznetz Vorhofflimmern e.V. [Atrial Fibrillation NETwork (AFNET)]
    Full Title: Anticoagulation using the direct factor Xa inhibitor apixaban during Atrial Fibrillation catheter Ablation: Comparison to vitamin K antagonist therapy.
    Medical condition: Atrial fibrillation catheter ablation
    Disease: Version SOC Term Classification Code Term Level
    19.0 10007541 - Cardiac disorders 10003658 Atrial fibrillation PT
    19.0 10007541 - Cardiac disorders 10071667 Persistent atrial fibrillation LLT
    19.0 10007541 - Cardiac disorders 10003661 Atrial fibrillation paroxysmal LLT
    19.0 10007541 - Cardiac disorders 10066582 Recurrent atrial fibrillation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) DK (Completed) GB (Completed) NL (Completed) ES (Completed) AT (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: 2008-003303-31 Sponsor Protocol Number: BAY59-7939/13238 Start Date*: 2009-01-13
    Sponsor Name:Bayer HealthCare AG
    Full Title: The Einstein CYP cohort study. Oral direct factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep-vein thrombosis or pulmonary embolism using a strong CYP 3A4 inducer.
    Medical condition: Patients with acute, proximal DVT or acute PE who concomitantly use a strong CYP 3A4 inducer for the entire 3-month study duration.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed) HU (Prematurely Ended) AT (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-002457-41 Sponsor Protocol Number: 150-CL-008 Start Date*: 2006-05-15
    Sponsor Name:Astellas Pharma Europe B.V.
    Full Title: Direct Factor Xa inhibitor YM150 for prevention of venous thromboembolism in patients undergoing elective total hip replacement. A double blind, parallel, dose-finding study in comparison with open...
    Medical condition: Elective primary hip replacement surgery
    Disease: Version SOC Term Classification Code Term Level
    10020096
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) CZ (Completed) SK (Completed) DE (Completed) SE (Completed) NO (Completed) FI (Completed) PT (Completed) GR (Completed) IT (Completed) LT (Completed) EE (Prematurely Ended) LV (Completed)
    Trial results: View results
    EudraCT Number: 2006-004495-13 Sponsor Protocol Number: BAY 59-7939/11702 Start Date*: 2007-03-12
    Sponsor Name:Bayer Healthcare AG
    Full Title: Oral direct factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep-vein thrombosis or pulmonary embolism.
    Medical condition: Treatment and secondary prevention of venous thromboembolism in patients with acute symptomatic deep- vein thrombosis or pulmonary embolism
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) ES (Completed) SE (Completed) FR (Completed) DE (Completed) FI (Completed) DK (Completed) HU (Completed) AT (Completed) IT (Completed) GB (Completed) CZ (Completed) NL (Completed) IE (Completed) LT (Completed) EE (Completed) LV (Completed) SK (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: 2020-000353-26 Sponsor Protocol Number: SAFE-SSPE Start Date*: 2021-09-20
    Sponsor Name:Bern University Hospital
    Full Title: Clinical Surveillance vs. Anticoagulation for Low-risk Patients with Isolated Subsegmental Pulmonary Embolism: A Multicenter Randomized Placebo-Controlled Non-Inferiority Trial
    Medical condition: Isolated subsegmental pulmonary embolism
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) FR (Trial now transitioned)
    Trial results: (No results available)
    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: 2011-001094-58 Sponsor Protocol Number: BAY 59-7939 / 15572 Start Date*: 2011-09-13
    Sponsor Name:Bayer HealthCare AG
    Full Title: Prospective, multi-center, randomized, heparin-controlled dose-finding trial to evaluate the efficacy and safety of rivaroxaban, a direct factor Xa inhibitor, on the background of standard dual ant...
    Medical condition: Symptomatic CAD patients due to undergo an elective (non emergent) Percutaneous Coronary Intervention (PCI) on one or two lesions in the native coronary vessel(s).
    Disease: Version SOC Term Classification Code Term Level
    13.1 10007541 - Cardiac disorders 10011078 Coronary artery disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2016-000485-34 Sponsor Protocol Number: 105SAR301 Start Date*: 2017-10-16
    Sponsor Name:TRACON Pharmaceuticals, Inc.
    Full Title: A randomized Phase 3 trial of TRC105 and pazopanib versus pazopanib alone in patients with advanced angiosarcoma (TAPPAS)
    Medical condition: Advanced angiosarcoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10002476 Angiosarcoma PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DE (Prematurely Ended) AT (Prematurely Ended) FR (Completed) ES (Prematurely Ended) PL (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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