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New Oral Anticoagulants (NOAC) in Stroke Patients (NOACISP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03826927
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
Registry to explore characteristics, use and management of new oral anticoagulants (NOAC) and vitamin K antagonists (VKA) treatment among patients with atrial fibrillation (AF) and recent cerebrovascular disease in a "real-world" setting at a stroke centre.

Condition or disease Intervention/treatment
Stroke Atrial Fibrillation Other: treatment with NOACs or VKAs

Detailed Description:
Registry to explore characteristics, use and management of new oral anticoagulants (NOAC) and vitamin K antagonists (VKA) treatment among patients with atrial fibrillation (AF) and recent cerebrovascular disease in a "real-world" setting at a stroke centre. Special interest is payed to conditions not or only in part investigated in the large randomised controlled Trials (RCT) and that are specific to patients with cerebrovascular disease. This includes early start of NOAC treatment after recent stroke, very old patients, multimorbidity, patients with a history of intracranial haemorrhage (ICH) and patient satisfaction and preferences with VKA/NOACS.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: New Oral Anticoagulants in Stroke Patients-Long Term Prevention of Recurrent Stroke in Patients With Atrial Fibrillation- a National Prospective Registry (NOACISP Long Term)
Actual Study Start Date : March 1, 2013
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
AF and cerebrovascular event
patients with AF and recent (< 3 month) stroke or transient ischaemic attack (TIA) or intracranial haemorrhage (ICH) with or without pre-existing oral anticoagulation, in whom treatment with NOACs or VKAs is initiated or continued for prevention of ischemic events
Other: treatment with NOACs or VKAs
treatment with NOACs or VKAs initiated or continued for prevention of ischemic events




Primary Outcome Measures :
  1. Change in anticoagulation (NOAC and VKA) treatment [ Time Frame: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event ]
    assessment of details of NOAC or VKA application (start, pause, dosage)


Secondary Outcome Measures :
  1. Change in glomerular filtration rate (GFR) [ Time Frame: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event ]
    impact of kidney function (in particular volatile GFR (ml/min) around the threshold for reduced dosage)

  2. Drug adherence for anticoagulation (VKA) treatment [ Time Frame: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event ]
    monitor the frequency of VKA use in patients with stroke or TIA attributable to AF, (a) among patients without pre-existing anticoagulation, (b) among patients under insufficient VKA therapy, and (c) among patients with sufficient VKA therapy, assessed by telephone or clinical visit

  3. Change in anticoagulant treatment [ Time Frame: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event ]
    If anticoagulant treatment was stopped or switched to any other drug (NOAC/VKA), reason for switching will be documented

  4. Recording of Adverse Events (AE) [ Time Frame: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event ]
    Causality for AE will be assessed as related, possibly related or non-related to the prescribed anticoagulant

  5. Change in modified Rankin Scale (mRS) [ Time Frame: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event ]
    modified Rankin Scale (mRS) is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability; scale runs from 0-6, running from perfect health (=0) without symptoms to death (=6)

  6. Co-morbidities [ Time Frame: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event ]
    Recording of co-morbidities

  7. Drug adherence for anticoagulation (NOAC) treatment [ Time Frame: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event ]
    monitor the frequency of NOAC use in patients with stroke or TIA attributable to AF, assessed by telephone or clinical visit



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients eligible for this registry will be recruited at the stroke centre at the University Hospital Basel
Criteria

Inclusion Criteria:

  • signed informed consent form (ICF)
  • existing or newly diagnosed AF
  • recent (< 3 month) stroke (ischemic or haemorrhagic) or TIA (=index event)
  • treatment with NOACs or VKAs is continued, changed or initiated for prevention of ischemic events

Exclusion Criteria:

  • patients not able or unwilling to sign ICF
  • patient is, in the opinion of the investigator, unlikely to comply with the scheduled follow-up visits or is unsuitable for any other reason
  • patients who will not be anticoagulated

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): NCT03826927


Contacts
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Contact: Philippe Lyrer, Prof. Dr. MD +41 61 265 44 35 philippe.lyrer@usb.ch
Contact: Marina Maurer +41 61 556 50 30 marina.maurer@usb.ch

Locations
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Switzerland
Felix Platter Spital Recruiting
Basel, Switzerland, 4002
Contact: Stefan Engelter, Prof. Dr. MD    +41 61 326 4063    stefan.engelter@fps.ch   
Dep. of Neurology, Hospital of the University of Basel Recruiting
Basel, Switzerland, 4031
Contact: Philippe Lyrer, Prof.Dr. med    +41 61 265 44 35    philippe.lyrer@usb.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Philippe Lyrer, Prof. Dr. MD University Hospital, Basel, Switzerland
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03826927    
Other Study ID Numbers: PB_2016-00662; me14Engelter2
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
New oral Anticoagulants (NOAC)
vitamin K antagonists (VKA)
cerebrovascular disease
Additional relevant MeSH terms:
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Stroke
Atrial Fibrillation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes