Atrial Fibrillation, Stroke
Conditions
Keywords
New oral Anticoagulants (NOAC), vitamin K antagonists (VKA), cerebrovascular disease
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.
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.
Interventions
OTHERtreatment with NOACs or VKAs
treatment with NOACs or VKAs initiated or continued for prevention of ischemic events
Sponsors
University Hospital, Basel, Switzerland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in anticoagulation (NOAC and VKA) treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Drug adherence for anticoagulation (VKA) treatment | 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 |
| Change in anticoagulant treatment | 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 |
| Recording of Adverse Events (AE) | 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 |
| Change in glomerular filtration rate (GFR) | 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) |
| Co-morbidities | time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event | Recording of co-morbidities |
| Drug adherence for anticoagulation (NOAC) treatment | 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 |
| Change in modified Rankin Scale (mRS) | 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) |
Countries
Switzerland
Outcome results
None listed