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Clinical trials for Vitamin K antagonists

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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    The EU Clinical Trials Register currently displays   44334   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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    34 result(s) found for: Vitamin K antagonists. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2007-004578-15 Sponsor Protocol Number: 01082007 Start Date*: 2008-03-03
    Sponsor Name:Dutch Heart Foundation
    Full Title: A randomised, double blind placebo controlled trial to (A) assess the optimal vitamin K dosage for supplementation, and (B) to access whether complications of anticoagulation treatment will diminis...
    Medical condition: Anti-coagulationtreatment with vitamine K antagonists.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10058768 Vitamin K LLT
    9.1 10053755 Vitamin K antagonist LLT
    9.1 10009728 Coagulation and bleeding analyses HLT
    9.1 10043607 Thrombosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-022826-34 Sponsor Protocol Number: 08092010 Start Date*: 2011-04-28
    Sponsor Name:
    Full Title: Randomised trial to investigate possible differences in biological availability and effectiveness between vitamin K solution in oil and vitamin K tablets.
    Medical condition: Lowering anticoagulant effect of vitamin K antagonists in case of over-anticoagulation or pending diagnostic or therapeutic invase action.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10053755 Vitamin K antagonist LLT
    12.1 10058768 Vitamin K LLT
    12.1 10011970 Decreased INR LLT
    12.1 10037818 Raised INR LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-000392-33 Sponsor Protocol Number: 2014PROPER3 Start Date*: 2015-06-30
    Sponsor Name:University Medical Center Groningen
    Full Title: Fixed versus variable dosing strategy of prothrombin complex concentrate for bleeding complications of vitamin K antagonists
    Medical condition: Major bleeding complications of vitamin K antagonists
    Disease: Version SOC Term Classification Code Term Level
    17.0 10042613 - Surgical and medical procedures 10009678 Clotting factor transfusion PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-004265-32 Sponsor Protocol Number: 0206 Start Date*: 2012-01-24
    Sponsor Name:Academic Medical Center
    Full Title: Left Ventricular Thrombus Formation after Acute Myocardial Infarction - a randomized multi-center trial comparing 2 different anti-thrombotic regimens
    Medical condition: Left Ventricular thrombus formation after acute myocardial infarction
    Disease: Version SOC Term Classification Code Term Level
    14.0 10042613 - Surgical and medical procedures 10053755 Vitamin K antagonist LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-005653-37 Sponsor Protocol Number: ICH-VKA Start Date*: 2009-05-29
    Sponsor Name:Universityhospital of Heidelberg
    Full Title: Multicenter, prospective randomized trial on the use of prothrombin complex and fresh frozen plasma in patients with intracerebral hemorrhage related to vitamin K antagonists (VKA)
    Medical condition: Intracerebral hemorrhage (ICH) in patients related to vitamin K antagonists
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10022754 Intracerebral hemorrhage LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Suspended by CA) DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-006887-12 Sponsor Protocol Number: HEPACO Start Date*: 2011-12-07
    Sponsor Name:Institut de Recerca HSCSP
    Full Title: Randomized controlled trial to compare treatment with oral anticoagulation with vitamin K antagonists versus low molecular weight heparin (bemiparin) in patients with anticoagulation criteria and h...
    Medical condition: Patients with gastrointestinal bleeding are not candidates for endoscopic treatment with oral anticoagulant previously.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    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 (Completed) DK (Prematurely Ended) SE (Prematurely Ended) AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-001484-79 Sponsor Protocol Number: RIVAROXAFL3002 Start Date*: 2013-02-06
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Randomized, Open-label, Active-controlled Multi-center Study to Evaluate the Safety of Rivaroxaban and Vitamin K Antagonists in Subjects Undergoing Catheter Ablation for Atrial Fibrillation
    Medical condition: Prevention of stroke and non-CNS systemic embolism in patients with nonvalvular atrial fibrillation who undergo catheter ablation
    Disease: Version SOC Term Classification Code Term Level
    16.1 10007541 - Cardiac disorders 10003658 Atrial fibrillation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2011-002234-39 Sponsor Protocol Number: BAY59-7939/15693 Start Date*: 2012-08-07
    Sponsor Name:Bayer HealthCare AG
    Full Title: A prospective, randomized, open-label, parallel-group, active-controlled, multicenter study exploring the efficacy and safety of once-daily oral rivaroxaban (BAY 59-7939) compared with that of dose...
    Medical condition: prevention of stroke and non-central nervous system systemic embolism in subjects with non-valvular atrial fibrillation scheduled for cardioversion
    Disease: Version SOC Term Classification Code Term Level
    14.1 10007541 - Cardiac disorders 10003658 Atrial fibrillation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) PT (Completed) ES (Completed) NL (Completed) DE (Completed) GR (Completed) BE (Completed) GB (Completed) IT (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2016-003086-25 Sponsor Protocol Number: 201600620 Start Date*: 2017-04-19
    Sponsor Name:University Medical Center Groningen
    Full Title: More precise dosing of acenocoumarol in patients aged 80 and above, a pilot study
    Medical condition: atrial fibrillation venous thrombo-embolism heart valve repair other diseases with an indication for anticoagulation with vitamin K antagonists
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-019250-41 Sponsor Protocol Number: 220901 Start Date*: 2010-05-27
    Sponsor Name:Baxter Innovations GmbH
    Full Title: AN INTERNATIONAL, MULTI-CENTRE, PROSPECTIVE, OPEN-LABEL, NON-RANDOMISED, UNCONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF PROTHROMPLEX TOTAL IN ORAL ANTICOAGULANT REVERSAL IN PATIENTS WITH A...
    Medical condition: Acquired Deficiency of Prothrombin Complex Coagulation Factors (II, VII, IX, X) due to oral anticoagulant therapy with Vitamin K antagonists
    Disease: Version SOC Term Classification Code Term Level
    12.1 10037045 Prothrombin deficiency LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2009-015336-15 Sponsor Protocol Number: 29462 Start Date*: 2009-09-30
    Sponsor Name:Department of Vascular Medicine of the Academic Medical Center
    Full Title: Long-term treatment for cancer patients with deep vein thrombosis or pulmonary embolism - a randomized open label study
    Medical condition: Deep venous thrombosis or pulmonary embolism in patients with cancer
    Disease: Version SOC Term Classification Code Term Level
    12.0 10066899 Venous thromboembolism LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing) IT (Completed) DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-003081-32 Sponsor Protocol Number: 1160.166 Start Date*: 2012-04-18
    Sponsor Name:Boehringer Ingelheim bv
    Full Title: An exploratory study to investigate the pharmacokinetics and effects of DABIgatran etexilate in patients with stable severe RENAL disease: DabiRenal
    Medical condition: Chronic kidney disease and coagulation
    Disease: Version SOC Term Classification Code Term Level
    15.0 10022891 - Investigations 10060318 Anticoagulation drug level PT
    15.0 10038359 - Renal and urinary disorders 10038444 Renal failure chronic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2015-005503-84 Sponsor Protocol Number: AFNET8 Start Date*: 2018-02-14
    Sponsor Name:Kompetenznetz Vorhofflimmern e.V.
    Full Title: A Safety Study Assessing Oral Anticoagulation with Apixaban versus Vitamin-K Antagonists in Patients with Atrial Fibrillation and End-Stage Kidney Disease (ESKD) on Chronic Hemodialysis Treatment.
    Medical condition: End-Stage Kidney Disease (ESKD) on Chronic Hemodialysis Treatment and Atrial Fibrillation
    Disease: Version SOC Term Classification Code Term Level
    20.0 10007541 - Cardiac disorders 10003658 Atrial fibrillation PT
    23.1 100000004857 10076412 Chronic kidney disease stage 5 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-007862-39 Sponsor Protocol Number: BE1116_3003 Start Date*: 2009-01-16
    Sponsor Name:CSL Behring GmbH
    Full Title: An open-label, randomized, multicenter Phase IIIb study to assess the efficacy, safety and tolerance of BERIPLEX® P/N compared with plasma for rapid reversal of coagulopathy induced by vitamin K an...
    Medical condition: Perioperative prophylaxis for emergency surgery in subjects who have an acquired deficiency of vitamin K-dependent coagulation factors and proteins C and S
    Disease: Version SOC Term Classification Code Term Level
    14.1 10042613 - Surgical and medical procedures 10065667 Haemorrhage prophylaxis PT
    14.1 100000004848 10009789 Coagulation factors decreased LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed) PL (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-003200-23 Sponsor Protocol Number: 2013DR3084 Start Date*: 2016-04-21
    Sponsor Name:University Hospital Basel; Neurology
    Full Title: Biomarkers and antithrombotic treatment in cervical artery dissection (TREAT-CAD)
    Medical condition: cervical artery dissection
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2018-003585-14 Sponsor Protocol Number: D-US-60010-001 Start Date*: 2020-04-08
    Sponsor Name:Ipsen Bioscience, Inc.
    Full Title: An open-label, randomised, multicentre, phase III study of irinotecan liposome injection, oxaliplatin, 5-fluorouracil/leucovorin versus nab-paclitaxel plus gemcitabine in subjects who have not prev...
    Medical condition: Previously Untreated, Metastatic Pancreatic Adenocarcinoma
    Disease: Version SOC Term Classification Code Term Level
    27.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033599 Pancreatic adenocarcinoma metastatic LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Ongoing) GB (GB - no longer in EU/EEA) HU (Completed) BE (Completed) CZ (Completed) AT (Completed) FR (Completed) PT (Completed) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2008-005887-14 Sponsor Protocol Number: B1321003 Start Date*: 2010-01-12
    Sponsor Name:Pfizer Ltd.
    Full Title: A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS ...
    Medical condition: Pulmonary Arterial Hypertension
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064911 Pulmonary arterial hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended) SK (Prematurely Ended) BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-005885-30 Sponsor Protocol Number: B1321001 Start Date*: 2010-01-12
    Sponsor Name:Pfizer Ltd
    Full Title: A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, SAFETY AND EFFICACY STUDY OF SITAXSENTAN SODIUM IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION
    Medical condition: Pulmonary arterial hypertension
    Disease: Version SOC Term Classification Code Term Level
    9.1 10037401 Pulmonary hypertensions HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended) SK (Prematurely Ended) BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-001350-21 Sponsor Protocol Number: APL2-PNH-209 Start Date*: 2020-12-08
    Sponsor Name:Apellis Pharmaceuticals, Inc.
    Full Title: An Open-Label, Single-Arm, Phase 2 Study to Evaluate the Safety, Pharmacokinetics, and Biologic Activity of Pegcetacoplan in Pediatric Patients with Paroxysmal Nocturnal Hemoglobinuria
    Medical condition: Paroxysmal Nocturnal Hemoglobinuria
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004857 10055629 Paroxysmal nocturnal hemoglobinuria LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended) NL (Trial now transitioned)
    Trial results: (No results available)
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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
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