AzTrials
AzTrials

StrokeNOACISPLongTerNCT03826927

New Oral Anticoagulants (NOAC) in Stroke Patients

An observational study of Stroke and Atrial Fibrillation, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Atrial Fibrillation
What is being tested?
treatment with NOACs or VKAs
Type of treatment
Pill or oral medicine
How many people
1,023 participants
Where
2 sitesSwitzerland
Study dates
1 Mar 2013to Aug 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Switzerland2 sites

  • Felix Platter Spital

    Basel, 4002

  • Dep. of Neurology, Hospital of the University of Basel

    Basel, 4031

Other trials in Switzerland

About this study

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)

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.

Read the 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.

Being tested
treatment with NOACs or VKAs
Keywords
New oral Anticoagulants (NOAC), vitamin K antagonists (VKA), cerebrovascular disease
Medical subject headings
Stroke, Atrial Fibrillation, Cerebrovascular Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • treatment with NOACs or VKAsOther

    treatment with NOACs or VKAs initiated or continued for prevention of ischemic events

Study groups in NCT03826927
Study groupRoleWhat they receive
AF and cerebrovascular eventpatients 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
Receives: Other: treatment with NOACs or VKAs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in anticoagulation (NOAC and VKA) treatment

    assessment of details of NOAC or VKA application (start, pause, dosage)

    Measured: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event

Secondary outcomes (7)

  1. Change in glomerular filtration rate (GFR)

    impact of kidney function (in particular volatile GFR (ml/min) around the threshold for reduced dosage)

    Measured: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event

  2. Drug adherence for anticoagulation (VKA) treatment

    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

    Measured: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event

  3. Change in anticoagulant treatment

    If anticoagulant treatment was stopped or switched to any other drug (NOAC/VKA), reason for switching will be documented

    Measured: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event

  4. Recording of Adverse Events (AE)

    Causality for AE will be assessed as related, possibly related or non-related to the prescribed anticoagulant

    Measured: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event

  5. Change in modified Rankin Scale (mRS)

    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)

    Measured: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event

  6. Co-morbidities

    Recording of co-morbidities

    Measured: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event

  7. Drug adherence for anticoagulation (NOAC) treatment

    monitor the frequency of NOAC use in patients with stroke or TIA attributable to AF, assessed by telephone or clinical visit

    Measured: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2019
  2. Study start1 Mar 2013
  3. Primary completionAug 2021
  4. Study completionAug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,023 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03826927
Sponsor's protocol ID
PB_2016-00662; me14Engelter2
Acronym
NOACISPLongTer
Status last verified
Aug 2023
First submitted
22 Jan 2019
Last updated
8 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36082252

  • Kimura S, Toyoda K, Yoshimura S, Minematsu K, Yasaka M, Paciaroni M, Werring DJ, Yamagami H, Nagao T, Yoshimura S, Polymeris A, Zietz A, Engelter ST, Kallmunzer B, Cappellari M, Chiba T, Yoshimoto T, Shiozawa M, Kitazono T, Koga M; SAMURAI, RELAXED, RAF, RAF-NOAC, CROMIS-2, NOACISP LONGTERM, Erlangen Registry and Verona Registry Investigators. Practical "1-2-3-4-Day" Rule for Starting Direct Oral Anticoagulants After Ischemic Stroke With Atrial Fibrillation: Combined Hospital-Based Cohort Study. Stroke. 2022 May;53(5):1540-1549. doi: 10.1161/STROKEAHA.121.036695. Epub 2022 Feb 2.

    PubMed 35105180

  • Seiffge DJ, De Marchis GM, Koga M, Paciaroni M, Wilson D, Cappellari M, Macha Md K, Tsivgoulis G, Ambler G, Arihiro S, Bonati LH, Bonetti B, Kallmunzer B, Muir KW, Bovi P, Gensicke H, Inoue M, Schwab S, Yaghi S, Brown MM, Lyrer P, Takagi M, Acciarrese M, Jager HR, Polymeris AA, Toyoda K, Venti M, Traenka C, Yamagami H, Alberti A, Yoshimura S, Caso V, Engelter ST, Werring DJ; RAF, RAF-DOAC, CROMIS-2, SAMURAI, NOACISP, Erlangen, and Verona registry collaborators. Ischemic Stroke despite Oral Anticoagulant Therapy in Patients with Atrial Fibrillation. Ann Neurol. 2020 Feb 12;87(5):677-87. doi: 10.1002/ana.25700. Online ahead of print.

    PubMed 32052481

  • Wilson D, Ambler G, Lee KJ, Lim JS, Shiozawa M, Koga M, Li L, Lovelock C, Chabriat H, Hennerici M, Wong YK, Mak HKF, Prats-Sanchez L, Martinez-Domeno A, Inamura S, Yoshifuji K, Arsava EM, Horstmann S, Purrucker J, Lam BYK, Wong A, Kim YD, Song TJ, Schrooten M, Lemmens R, Eppinger S, Gattringer T, Uysal E, Tanriverdi Z, Bornstein NM, Assayag EB, Hallevi H, Tanaka J, Hara H, Coutts SB, Hert L, Polymeris A, Seiffge DJ, Lyrer P, Algra A, Kappelle J, Al-Shahi Salman R, Jager HR, Lip GYH, Mattle HP, Panos LD, Mas JL, Legrand L, Karayiannis C, Phan T, Gunkel S, Christ N, Abrigo J, Leung T, Chu W, Chappell F, Makin S, Hayden D, Williams DJ, Kooi ME, van Dam-Nolen DHK, Barbato C, Browning S, Wiegertjes K, Tuladhar AM, Maaijwee N, Guevarra C, Yatawara C, Mendyk AM, Delmaire C, Kohler S, van Oostenbrugge R, Zhou Y, Xu C, Hilal S, Gyanwali B, Chen C, Lou M, Staals J, Bordet R, Kandiah N, de Leeuw FE, Simister R, van der Lugt A, Kelly PJ, Wardlaw JM, Soo Y, Fluri F, Srikanth V, Calvet D, Jung S, Kwa VIH, Engelter ST, Peters N, Smith EE, Yakushiji Y, Orken DN, Fazekas F, Thijs V, Heo JH, Mok V, Veltkamp R, Ay H, Imaizumi T, Gomez-Anson B, Lau KK, Jouvent E, Rothwell PM, Toyoda K, Bae HJ, Marti-Fabregas J, Werring DJ; Microbleeds International Collaborative Network. Cerebral microbleeds and stroke risk after ischaemic stroke or transient ischaemic attack: a pooled analysis of individual patient data from cohort studies. Lancet Neurol. 2019 Jul;18(7):653-665. doi: 10.1016/S1474-4422(19)30197-8. Epub 2019 May 23.

    PubMed 31130428

  • Hert L, Polymeris AA, Schaedelin S, Lieb J, Seiffge DJ, Traenka C, Fladt J, Thilemann S, Gensicke H, De Marchis GM, Bonati L, Lyrer P, Engelter ST, Peters N. Small vessel disease is associated with an unfavourable outcome in stroke patients on oral anticoagulation. Eur Stroke J. 2020 Mar;5(1):63-72. doi: 10.1177/2396987319888016. Epub 2019 Nov 12.

    PubMed 32232171

  • Cappellari M, Seiffge DJ, Koga M, Paciaroni M, Forlivesi S, Turcato G, Bovi P, Yoshimura S, Tanaka K, Shiozawa M, Yoshimoto T, Miwa K, Takagi M, Inoue M, Yamagami H, Caso V, Tsivgoulis G, Venti M, Acciarresi M, Alberti A, Toni D, Polymeris A, Bonetti B, Agnelli G, Toyoda K, Engelter ST, De Marchis GM; SAMURAI-NVAF, RAF-NOAC, NOACISP LONG-TERM, and Verona Study Groups. A nomogram to predict unfavourable outcome in patients receiving oral anticoagulants for atrial fibrillation after stroke. Eur Stroke J. 2020 Dec;5(4):384-393. doi: 10.1177/2396987320945840. Epub 2020 Nov 26.

    PubMed 33598557

  • Polymeris AA, Macha K, Paciaroni M, Wilson D, Koga M, Cappellari M, Schaedelin S, Zietz A, Peters N, Seiffge DJ, Haupenthal D, Gassmann L, De Marchis GM, Wang R, Gensicke H, Stoll S, Thilemann S, Avramiotis NS, Bonetti B, Tsivgoulis G, Ambler G, Alberti A, Yoshimura S, Brown MM, Shiozawa M, Lip GYH, Venti M, Acciarresi M, Tanaka K, Mosconi MG, Takagi M, Jager RH, Muir K, Inoue M, Schwab S, Bonati LH, Lyrer PA, Toyoda K, Caso V, Werring DJ, Kallmunzer B, Engelter ST; NOACISP-LONGTERM, Erlangen Registry, CROMIS-2, RAF, RAF-DOAC, SAMURAI-NVAF and Verona Registry Collaborators. Oral Anticoagulants in the Oldest Old with Recent Stroke and Atrial Fibrillation. Ann Neurol. 2022 Jan;91(1):78-88. doi: 10.1002/ana.26267. Epub 2021 Nov 29.

    PubMed 34747514

  • Seiffge DJ, Paciaroni M, Wilson D, Koga M, Macha K, Cappellari M, Schaedelin S, Shakeshaft C, Takagi M, Tsivgoulis G, Bonetti B, Kallmunzer B, Arihiro S, Alberti A, Polymeris AA, Ambler G, Yoshimura S, Venti M, Bonati LH, Muir KW, Yamagami H, Thilemann S, Altavilla R, Peters N, Inoue M, Bobinger T, Agnelli G, Brown MM, Sato S, Acciarresi M, Jager HR, Bovi P, Schwab S, Lyrer P, Caso V, Toyoda K, Werring DJ, Engelter ST, De Marchis GM; CROMIS-2, RAF, RAF-DOAC, SAMURAI, NOACISP LONGTERM, Erlangen and Verona registry collaborators. Direct oral anticoagulants versus vitamin K antagonists after recent ischemic stroke in patients with atrial fibrillation. Ann Neurol. 2019 Jun;85(6):823-834. doi: 10.1002/ana.25489. Epub 2019 Apr 30.

    PubMed 30980560

  • De Marchis GM, Seiffge DJ, Schaedelin S, Wilson D, Caso V, Acciarresi M, Tsivgoulis G, Koga M, Yoshimura S, Toyoda K, Cappellari M, Bonetti B, Macha K, Kallmunzer B, Cereda CW, Lyrer P, Bonati LH, Paciaroni M, Engelter ST, Werring DJ. Early versus late start of direct oral anticoagulants after acute ischaemic stroke linked to atrial fibrillation: an observational study and individual patient data pooled analysis. J Neurol Neurosurg Psychiatry. 2022 Feb;93(2):119-125. doi: 10.1136/jnnp-2021-327236. Epub 2021 Oct 11.

    PubMed 34635567

  • Zietz A, Polymeris AA, Helfenstein F, Schaedelin S, Hert L, Wagner B, Seiffge DJ, Traenka C, Altersberger VL, Dittrich T, Kaufmann J, Ravanelli F, Fladt J, Fisch U, Thilemann S, De Marchis GM, Gensicke H, Bonati LH, Katan M, Fischer U, Lyrer P, Engelter ST, Peters N. The impact of competing stroke etiologies in patients with atrial fibrillation. Eur Stroke J. 2023 Sep;8(3):703-711. doi: 10.1177/23969873231185220. Epub 2023 Jul 4.

    PubMed 37401394

  • 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.

    PubMed 36203998

  • 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.

    PubMed 34311567

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke and Atrial Fibrillation, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03826927, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in