New Oral Anticoagulants in Stroke Patients-Long Term Prevention of Recurrent Stroke in Patients With Atrial Fibrillation- a National Prospective Registry (NOACISP Long Term)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- University Hospital, Basel, Switzerland
- Enrollment
- 1023
- Locations
- 2
- Primary Endpoint
- Change in anticoagulation (NOAC and VKA) treatment
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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 Outcomes
- Co-morbidities(time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event)
- Change in anticoagulant treatment(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)(time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event)
- 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)
- 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)
- 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)
- 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)