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Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation (PRAGUE-17)

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ClinicalTrials.gov Identifier: NCT02426944
Recruitment Status : Recruiting
First Posted : April 27, 2015
Last Update Posted : January 30, 2019
Sponsor:
Collaborator:
Ministry of Health, Czech Republic
Information provided by (Responsible Party):
Pavel Osmancik, Charles University, Czech Republic

Brief Summary:
Atrial fibrillation (AF) is the most common cardiac arrhythmia with a prevalence of 1-2%. Without antithrombotic treatment, the annual risk of a cardioembolic event is 5-6%. The source of a cardioembolic event is a thrombus, which usually forms in the left atrial appendage (LAA). The prevention of cardioembolic events involves treatment with anticoagulant drugs, which were limited to, until recently, vitamin K antagonists (e.g. warfarin). Anticoagulant treatment with warfarin can lead to adverse bleeding events, some of which can be life threatening. Recently, two new options for thrombus prevention have been developed. The first is the novel anticoagulants (NOAC), which were associated with slightly better safety profiles due to a lower frequency of intracranial bleeding in large randomized trials . The second option involves interventional occlusion of the LAA. The aim of this project is to compare the LAA occlusion intervention to NOAC pharmacological treatment in a randomized multicenter study of AF patients at high risk of a cardioembolic event.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: NOAC Device: Left atrial appendage closure Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Interventional Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in High-risk Patients With Atrial Fibrillation (PRAGUE-17 Study)
Study Start Date : April 2015
Estimated Primary Completion Date : May 20, 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LAAO group
Patients will be treated interventionally by left atrial appendage occlusion (LAAO). LAAO will be done using Amulet or Watchman device.
Device: Left atrial appendage closure
The patients will be treated by interventional closure of the left atrial appendage.

Experimental: NOAC group
Patients will be treated by novel anticoagulants (NOAC).
Drug: NOAC
Medical arm, patients will be treated by NOAC.




Primary Outcome Measures :
  1. Combined endpoint: stroke OR systemic cardioembolic event OR clinically significant bleeding OR cardiovascular death OR procedure or device-related complications [ Time Frame: 12 months after randomization ]
    The primary endpoint is the combination of stroke, other systemic cardiovascular event, clinically significant bleeding (i.e. a decrease in hemoglobin level of 20 g/l or more over a 24-hour period, transfusion of 2 or more units of packed red cells, bleeding at a critical site (intracranial, intraspinal, intraocular, pericardial, intramuscular with compartment syndrome, or retroperitoneal), or fatal bleeding), cardiovascular death or procedure or device-related complications (i.e. a pericardial effusion with a need for drainage, surgical or pericardiocentesis; cardioembolic event during the procedure; significant periprocedural bleeding (such as major vascular bleeding with a need for surgical revision, or blood concentrate transfusion); device embolization, or thrombus of the device with a consequent cardioembolic event).


Secondary Outcome Measures :
  1. Stroke [ Time Frame: 12 months ]
    The sudden onset of a focal neurologic deficit, from a nontraumatic cause, in a location consistent with the territory of a major cerebral artery and categorized as either an ischemic, hemorrhagic or unspecified

  2. Systemic cardioembolic event [ Time Frame: 12 months ]
    An acute vascular occlusion of an extremity or organ, documented by means of imaging (CT angiography, percutaneous interventional angiography), surgery, or autopsy.

  3. Clinically significant bleeding [ Time Frame: 12 months ]
    An overt bleeding accompanied by one or more of the following: a decrease in hemoglobin level of 20 g/l or more over a 24-hour period, transfusion of 2 or more units of packed red cells, bleeding at a critical site (intracranial, intraspinal, intraocular, pericardial, intramuscular with compartment syndrome, or retroperitoneal), or fatal bleeding

  4. Cardiovascular death [ Time Frame: 12 months ]
    Death from cardiovascular causes

  5. An procedure or device-related complications [ Time Frame: 12 months ]
    A pericardial effusion with a need for drainage, surgical or pericardiocentesis, or cardioembolic event during the procedure, or significant periprocedural bleeding (i.e. major vascular bleeding with a need for surgical revision, or blood concentrate transfusion), or device embolization, or (5) thrombus of the device with a consequent cardioembolic event.

  6. Minor bleeding [ Time Frame: 12 months ]
    Any bleeding with a need for hospitalization, instrumental procedure or discontinuation of anticoagulation or antithrombotic treatment.

  7. Economical comparison - all costs associated with the treatment and adverse events [ Time Frame: 12 months ]
    In the interventional group, costs for device and associated medication (i.e.aspirin and clopidogrel for six weeks). In medical group, all costs for the anticoagulation medication during the whole study period. In both groups, costs associated for hospitalizations due to adverse events will be added.



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

Inclusion Criteria:

  1. history of significant bleeding (i.e. bleeding which required intervention or hospitalization), even in the absence of anticoagulation treatment at the time of the bleeding event, or
  2. a cardioembolic event, which occurred on anticoagulation, or
  3. a high risk profile of the patient, defined as a CHA2DS2-VASc score ≥ 3 and a HAS-BLED score ≥ 2

Exclusion Criteria:

  1. thrombus in the LA or LAA;
  2. mechanical valve prosthesis;
  3. mitral stenosis;
  4. previous LAA ligation during cardiac surgery;
  5. life expectancy less than 2 years;
  6. comorbidities other than AF, which present an indication for anticoagulation;
  7. patent foramen ovale with atrial septal aneurysm
  8. mobile plaque in the aorta;
  9. symptomatic atherosclerosis of the carotid artery;
  10. pericardial effusion greater than 10 mm;
  11. clinically significant bleeding within the 30 days prior to the scheduled procedure;
  12. stroke or other cardioembolic event within the 30 days prior to the scheduled procedure;
  13. acute coronary syndrome within the 90 days prior to the scheduled procedure,
  14. gravidity,
  15. significant valvular disease,
  16. creatinine clearance less than 30 ml/min

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): NCT02426944


Locations
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Czechia
Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady Recruiting
Prague, Czechia, 10034
Contact: Pavel Osmancik, MD, PhD    00420 ext 721544447    pavel.osmancik@volny.cz   
Sponsors and Collaborators
Charles University, Czech Republic
Ministry of Health, Czech Republic

Publications of Results:

Other Publications:
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Responsible Party: Pavel Osmancik, 3. Faculty of Medicine and University Hospital Kralovske Vinohrady, Charles University, Czech Republic
ClinicalTrials.gov Identifier: NCT02426944     History of Changes
Other Study ID Numbers: PRAGUE - 17
First Posted: April 27, 2015    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019

Keywords provided by Pavel Osmancik, Charles University, Czech Republic:
atrial fibrillation
cardioembolic event
stroke
left atrial appendage closure
novel anticoagulants

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anticoagulants