New Oral Anticoagulants (NOAC) in Stroke Patients
- Conditions
- StrokeAtrial Fibrillation
- Interventions
- Other: treatment with NOACs or VKAs
- Registration Number
- NCT03826927
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1023
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description AF and cerebrovascular event treatment with NOACs or VKAs 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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)
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)
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
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
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
Trial Locations
- Locations (2)
Felix Platter Spital
🇨🇭Basel, Switzerland
Dep. of Neurology, Hospital of the University of Basel
🇨🇭Basel, Switzerland