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Trial record 87 of 333 for:    DABIGATRAN

Left Atrial Thrombus Reduction - Effect of Dabigatran Versus Phenprocoumon

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ClinicalTrials.gov Identifier: NCT02591225
Recruitment Status : Unknown
Verified November 2015 by Peter Bernhardt, University of Ulm.
Recruitment status was:  Recruiting
First Posted : October 29, 2015
Last Update Posted : November 13, 2015
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Peter Bernhardt, University of Ulm

Brief Summary:
This is a single-center, randomized, two treatment groups, open, phase IV clinical study in subjects with atrial fibrillation and left atrial thrombus. At Visit 0 (Screening Visit) subjects with left atrial thrombus established in transesophageal echocardiography (TEE) are eligible to entry in the study. If the subjects fulfill all other in- and exclusion criteria and undersign the informed consent the baseline cranial magnet resonance imaging (MRI) can be performed followed by randomization to one of the two treatment groups (Phenprocoumon or Dabigatran) at Visit 1 (Baseline Visit). The subjects will be treated for 12 months with Phenprocoumon (INR adjusted once daily) or Dabigatran 150 mg twice daily. Routinely clinical follow up visits will be done at week 4, month 3, month 6, month 9 and month 12. Follow up TEE will be performed after 4 weeks and after 12 months also the follow up cranial MRI at this visit. If the subject was randomized in the VKA group routinely INR measurements will performed.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Left Atrial Thrombosis Drug: Dabigatranetexilate Drug: Phenprocoumon Phase 4

Detailed Description:

Bakground and study rationale: Left atrial (LA) thrombi are found in 2.5 - 18% of subjects with atrial fibrillation (AF) depending on the subject population. Subjects with LA thrombi have a particularly increased risk for cerebral and peripheral embolism. Consequently, oral anticoagulation is recommended in those subjects. Transesophageal echocardiography (TEE) is suited and is capable of visualizing and deecting LA thrombi. Cranial magnetic resonance imaging (MRI) has a high accurancy for detecting ailent cerebral mircoembolism. However, under continued effective anticoagulation with the vitamin K antagonist (VKA) Phenprocoumon we have shown that only 56% of LA thrombi resolve during a 12 months TEE observational period. At 1 month only 16% of the thrombi disappeared. However, cureent treatment guidelines recommend 4 weeks of effective anticoagulations prior cardioversion, independent of LA thrombus. In our subject population 84% of LA thrombi would have still been presented at 4 weeks VKA therapy and thus, would have had an increased risk of thromboembolism, if cardioversion, in accordance with current guidelines, would have performed. It is well known that thrombin plays a central role in the formation, growth, maintenance, and consolidation of thrombus. Direct thrombin inhibition has been shown to block these processes and leads to inhibition of thrombus. In vivo, it has been shown to reduce 90% of the preformed, half-hour-old-thrombus. This effect is probably due to better inhibition of the catalytically active clot-bound thrombin. Newer oral anticoagulants, like the direct thrombin inhibitor Dabigatran are therefore very promising for resolution of LA thrombi in comparison to VKA, which has not been investigated previously.

Efficacy variables: Expliration of possible differences for the reduction of left atrial thrombus size evaluated by TEE (primary) and silent cerebral embolism (secondary) detected by cranial MRI at baseline anf after a 12 month treated period with Phenprocoumon or Dabigatran in order to gain mire detailed information and to generate valid hypotheses for further clinical trials.

Overview: This is a single-center, randomized, two treatment groups, open, phase IV clinical study in subjects with atrial fibrillation and left atrial thrombus. At visit 0 (Screening visit) subjects with left atrial thrombus established in TEE are eligable to entry in the study. If the subjects fulfill all other in- and exclusion criteria and undersign the informed consent the baseline cranial MRI can be performed follwoed by randomization to one of the two treatment groups (Phenprocoumon or Dabigatran) at Visit 1 (Baseline visit). The subjects will be treated for 12 months with Phenprocoumon (INR adjusted once daily) or Dabigatran 150 mg twice daily. Routinly clinical follow up visits bill be done at week 4, month 3, month 6, month 9 and month 12. Follow up TEE will be performed after week 4 and month 12 also the follow up cranial MRI at this visit. If the subject was randomized in the VKA group routinely INR measurements will performed.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phenprocoumon Versus Dabigatran in Subjects With Atrial Fibrillation and Left Atrial Thrombus - a Prospective, Randomized, Controlled, Open-label One Year Follow-up Pilot Study
Study Start Date : October 2015
Estimated Primary Completion Date : December 2017


Arm Intervention/treatment
Experimental: Dabigatranetexilate
Dabigatran capsula 150 mg; oral; bid; treatment period 12 months
Drug: Dabigatranetexilate
After inclusion of the subjects with LA thrombus, they are treated according to the randomization either with Dabigatran (150 mg bid) or Phenprocoumon (INR adjusted once) for the treatment period of 12 months.
Other Name: Pradaxa

Active Comparator: Phenprocoumon
Phenprocoumon INR adjusted; oral; once daily; treatment period 12 months
Drug: Phenprocoumon
After inclusion of the subjects with LA thrombus, they are treated according to the randomization either with Dabigatran (150 mg bid) or Phenprocoumon (INR adjusted once) for the treatment period of 12 months.
Other Name: Marcumar




Primary Outcome Measures :
  1. left atrial thrombus resolution [ Time Frame: 12 months ]
    thrombus size evaluated by transeshophageal echocardiography


Secondary Outcome Measures :
  1. cerebral emolism [ Time Frame: 12 months ]
    cerebral embolic events detected by magnetic resonance imaging



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • signed and dated written informed consent
  • atrail fibrillation
  • left atrial thrombus
  • negative pregnancy test in woman with childbearin potentail
  • subjects who have the ability to understand and comply the instructions for participation

Exclusion Criteria:

  • low body weight < 50 kg
  • instable cardiac or respiratory condition
  • contraindication for Phenprocoumon or Dabigatran
  • severely reduced renal function (CrCl < 30 ml/min)
  • inadequate hepatic function (AST and ALT higher than 2 x ULN)
  • Contraindication for MRI
  • Durg/alcohol abusus
  • Pregnant or nursing woman
  • subject is an employee of any involved study investigator
  • Parallel participation in another clinical trial
  • Treatment with another investigational product

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02591225


Contacts
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Contact: Brigitte Ruess +4973150045250 brigitte.ruess@uniklinik-ulm.de
Contact: Uta Dichristin +4973150045250 uta.dichristin@uniklinik-ulm.de

Locations
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Germany
Department of Internal Medicine II, University Hospital Ulm Recruiting
Ulm, Germany, 89081
Contact: Peter Bernhardt, MD    +49 731 500-45060    peter.bernhardt@uniklinik-ulm.de   
Contact: Brigitte Ruess    +49 731 500-45246    brigitte.ruess@uniklinik-ulm.de   
Sponsors and Collaborators
University of Ulm
Boehringer Ingelheim
Investigators
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Principal Investigator: Peter Bernhardt, MD University Hospital Ulm, Department of Internal Medicine II

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Responsible Party: Peter Bernhardt, Professor Dr., University of Ulm
ClinicalTrials.gov Identifier: NCT02591225     History of Changes
Other Study ID Numbers: BI 1160.206
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: November 2015
Keywords provided by Peter Bernhardt, University of Ulm:
left atrial thrombus size
transesophageale echocardiography
silent cerebral embolism
Additional relevant MeSH terms:
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Dabigatran
Atrial Fibrillation
Thrombosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Phenprocoumon
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants