New Oral Anticoagulants (NOAC) in Stroke Patients (NOACISPLongTer)

• ClinicalTrials.gov Identifier: NCT03826927
• Recruitment Status: Active, not recruiting
• First Posted: February 1, 2019
• Last Update Posted: December 22, 2022
• Sponsor: University Hospital, Basel, Switzerland
• Information provided by (Responsible Party): University Hospital, Basel, Switzerland

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
Stroke; Atrial Fibrillation	Other: treatment with NOACs or VKAs

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

• Study Type: Observational
• Actual Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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)
• Actual Study Start Date: March 1, 2013
• Estimated Primary Completion Date: March 2023
• Estimated Study Completion Date: March 31, 2023

Groups and Cohorts

Group/Cohort	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 :

1. 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 Outcome Measures :

1. Change in glomerular filtration rate (GFR) [ Time Frame: 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)
2. Drug adherence for anticoagulation (VKA) treatment [ Time Frame: 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
3. Change in anticoagulant treatment [ Time Frame: 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
4. Recording of Adverse Events (AE) [ Time Frame: 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
5. Change in modified Rankin Scale (mRS) [ Time Frame: 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)
6. Co-morbidities [ Time Frame: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event ]
   Recording of co-morbidities
7. Drug adherence for anticoagulation (NOAC) treatment [ Time Frame: 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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Patients eligible for this registry will be recruited at the stroke centre at the University Hospital Basel

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

Switzerland

Felix Platter Spital

Basel, Switzerland, 4002

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wagner B, Hert L, Polymeris AA, Schaedelin S, Lieb JM, Seiffge DJ, Traenka C, Thilemann S, Fladt J, Altersberger VL, Zietz A, Dittrich TD, Fisch U, Gensicke H, De Marchis GM, Bonati LH, Lyrer PA, Engelter ST, Peters N. Impact of type of oral anticoagulants in patients with cerebral microbleeds after atrial fibrillation-related ischemic stroke or TIA: Results of the NOACISP-LONGTERM registry. Front Neurol. 2022 Sep 20;13:964723. doi: 10.3389/fneur.2022.964723. eCollection 2022.

Meya L, Polymeris AA, Schaedelin S, Schaub F, Altersberger VL, Traenka C, Thilemann S, Wagner B, Fladt J, Hert L, Yoshimura S, Koga M, Zietz A, Dittrich T, Fisch U, Toyoda K, Seiffge DJ, Peters N, De Marchis GM, Gensicke H, Bonati LH, Lyrer PA, Engelter ST. Oral Anticoagulants in Atrial Fibrillation Patients With Recent Stroke Who Are Dependent on the Daily Help of Others. Stroke. 2021 Nov;52(11):3472-3481. doi: 10.1161/STROKEAHA.120.033862. Epub 2021 Jul 27.

• Responsible Party: University Hospital, Basel, Switzerland
• ClinicalTrials.gov Identifier: NCT03826927
• Other Study ID Numbers: PB_2016-00662; me14Engelter2
• First Posted: February 1, 2019
• Last Update Posted: December 22, 2022
• Last Verified: December 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Basel, Switzerland:

New oral Anticoagulants (NOAC); vitamin K antagonists (VKA); cerebrovascular disease

Additional relevant MeSH terms:

Stroke; Atrial Fibrillation; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes