New Oral Anticoagulants (NOAC) in Stroke Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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New Oral Anticoagulants in Stroke Patients-Long Term Prevention of Recurrent Stroke in Patients With Atrial Fibrillation- a National Prospective Registry (NOACISP Long Term)

Conditions
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Stroke, Atrial Fibrillation

Intervention / Treatment
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* Other: treatment with NOACs or VKAs


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AF and cerebrovascular event<br>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<br>* treatment with NOACs or VKAs initiated or continued for prevention of ischemic events<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anticoagulation (NOAC and VKA) treatment | assessment of details of NOAC or VKA application (start, pause, dosage) | time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glomerular filtration rate (GFR) | impact of kidney function (in particular volatile GFR (ml/min) around the threshold for reduced dosage) | time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event | 
| Drug adherence for anticoagulation (VKA) treatment | 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 | time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event | 
| Change in anticoagulant treatment | If anticoagulant treatment was stopped or switched to any other drug (NOAC/VKA), reason for switching will be documented | time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event | 
| Recording of Adverse Events (AE) | Causality for AE will be assessed as related, possibly related or non-related to the prescribed anticoagulant | time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event | 
| Change in modified Rankin Scale (mRS) | 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) | time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event | 
| Co-morbidities | Recording of co-morbidities | time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event | 
| Drug adherence for anticoagulation (NOAC) treatment | monitor the frequency of NOAC use in patients with stroke or TIA attributable to AF, assessed by telephone or clinical visit | time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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New oral Anticoagulants (NOAC), vitamin K antagonists (VKA), cerebrovascular disease