NOACISP: New Oral Anticoagulants (NOAC) in Stroke Patients
Study Details
Study Description
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 | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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 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)
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Felix Platter Spital | Basel | Switzerland | 4002 | |
| 2 | Dep. of Neurology, Hospital of the University of Basel | Basel | Switzerland | 4031 |
Sponsors and Collaborators
- University Hospital, Basel, Switzerland
Investigators
- Principal Investigator: Philippe Lyrer, Prof. Dr. MD, University Hospital, Basel, Switzerland
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PB_2016-00662; me14Engelter2