Clinical trial NCT03826927: New Oral Anticoagulants (NOAC) in Stroke Patients
Official title: New Oral Anticoagulants in Stroke Patients-Long Term Prevention of Recurrent Stroke in Patients With Atrial Fibrillation- a National Prospective Registry (NOACISP Long Term)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Atrial Fibrillation
Keywords: New oral Anticoagulants (NOAC)
vitamin K antagonists (VKA)
cerebrovascular disease
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-02-01
Enrollment: 1023
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients eligible for this registry will be recruited at the stroke centre at the University Hospital Basel

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.

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

Primary outcomes:
measure: Change in anticoagulation (NOAC and VKA) treatment
timeFrame: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event
Secondary outcomes:
measure: Change in glomerular filtration rate (GFR)
timeFrame: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event
measure: Drug adherence for anticoagulation (VKA) treatment
timeFrame: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event
measure: Change in anticoagulant treatment
timeFrame: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event
measure: Recording of Adverse Events (AE)
timeFrame: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event
measure: Change in modified Rankin Scale (mRS)
timeFrame: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event
measure: Co-morbidities
timeFrame: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event
measure: Drug adherence for anticoagulation (NOAC) treatment
timeFrame: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Felix Platter Spital
city: Basel
country: Switzerland
facility: Dep. of Neurology, Hospital of the University of Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Philippe Lyrer, Prof. Dr. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Polymeris AA, Zietz A, Schaub F, Meya L, Traenka C, Thilemann S, Wagner B, Hert L, Altersberger VL, Seiffge DJ, Lyrer F, Dittrich T, Piot I, Kaufmann J, Barone L, Dahlheim L, Flammer S, Avramiotis NS, Peters N, De Marchis GM, Bonati LH, Gensicke H, Engelter ST, Lyrer PA. Once versus twice daily direct oral anticoagulants in patients with recent stroke and atrial fibrillation. Eur Stroke J. 2022 Sep;7(3):221-229. doi: 10.1177/23969873221099477. Epub 2022 May 10.
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