Stroke despite treatment with blood thinners: causes and outcomes
| ISRCTN | ISRCTN48292829 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48292829 |
| Secondary identifying numbers | KEK Bern 2019-01010 |
- Submission date
- 06/06/2021
- Registration date
- 23/07/2021
- Last edited
- 11/04/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Atrial fibrillation is a heart condition that causes an irregular and often abnormally fast heart rate.
Anticoagulants are medicines that help prevent blood clots. They're given to people at a high risk of getting clots, to reduce their chances of developing serious conditions such as strokes and heart attacks.
Although oral anticoagulants reduce the risk of ischemic stroke in patients with atrial fibrillation (AF), they do not eliminate it. In fact, anticoagulated AF patients still have a substantial stroke risk of about 1.5% per year. There is only limited knowledge about the causes of stroke despite anticoagulation and the subsequent treatment strategies that are needed to prevent another future stroke.
Who can participate?
This is a retrospective observational study including data of adult patients (no upper age limit, both sexes) with (a) an imaging-proven ischemic stroke, (b) nonvalvular atrial fibrillation known before stroke onset and (c) treatment with oral anticoagulants at stroke onset.
What does the study involve?
This observational study will determine the most probable cause of stroke according to one of the following categories: (a) competing stroke etiology other than atrial fibrillation; (b) medication error or (c) treatment failure (neither (a) nor (b)). The study will examine the characteristics of patients stratified to these categories, as well as the subsequent prevention strategies (including but not limited to switching the type of anticoagulant and adding antiplatelets) and 3-month clinical outcomes using standard statistical methodology including multivariable regression analyses.
Where is the study run from?
The study is led by investigators from the University Hospitals of Bern, Basel and Heidelberg.
When is the study starting and how long is it expected to run for?
The study was conceived in June 2020 and data collection was completed in March 2021.
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
David J Seiffge, MD, David.Seiffge@insel.ch
Jan Purrucker, MD, Jan.Purrucker@med.uni-heidelberg.de
Alexandros A Polymeris, MD, Alexandros.Polymeris@usb.ch
Thomas R Meinel, MD, Thomas.Meinel@insel.ch
Contact information
Public
Department of Neurology and Stroke Center, University Hospital Basel
Petersgraben 4
Basel
4031
Switzerland
 ORCID ID |
0000-0002-9475-2208 |
|---|---|
| Phone | +41 61 328 73 19 |
| alexandros.polymeris@usb.ch |
Scientific
Department of Neurology and Stroke Center, Inselspital, University Hospital Bern
Freiburgstrasse 18
Bern
3010
Switzerland
| ORCID ID |
0000-0003-3890-3849 |
|---|---|
| Phone | +41 31 632 21 11 |
| david.seiffge@insel.ch |
Study information
| Study design | Multicenter observational retrospective analysis of individual patient data |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not applicable (retrospective study) |
| Scientific title | Ischemic stroke despite anticoagulant therapy in patients with atrial fibrillation - causes, subsequent treatment strategies and outcomes |
| Study hypothesis | 1. The causes of ischemic stroke despite anticoagulation are heterogeneous. 2. Switching the type of anticoagulant or adding antiplatelets as subsequent prevention strategies do not reduce the risk of stroke recurrence. |
| Ethics approval(s) | Approved 17/09/2019, KEK Bern (Murtenstrasse 31, 3010 Bern, Switzerland; +41 31 633 70 70; info.kek.kapa@gef.be.ch), ref: 2019-01010 |
| Condition | Ischemic stroke despite oral anticoagulation in patients with atrial fibrillation |
| Intervention | This retrospective observational study will determine the most probable cause of stroke according to one of the following categories: (a) competing stroke etiology other than atrial fibrillation; (b) medication error or (c) treatment failure (neither (a) nor (b)). The study will examine the characteristics of patients stratified to these categories, as well as the subsequent prevention strategies (including but not limited to switching the type of anticoagulant and adding antiplatelets) and 3-month clinical outcomes using standard statistical methodology including multivariable regression analyses. |
| Intervention type | Other |
| Primary outcome measure | Measured using patient records: 1. Recurrent ischemic stroke at 3 months 2. Intracranial hemorrhage at 3 months 3. All-cause death at 3 months |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/06/2020 |
| Overall study end date | 01/03/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 2,000 - 3,000 |
| Total final enrolment | 2946 |
| Participant inclusion criteria | Patients presenting with imaging proven ischemic stroke who had nonvalvular atrial fibrillation known before stroke onset and were on oral anticoagulant treatment at stroke onset |
| Participant exclusion criteria | Patients with mechanical heart valves and those without information on anticoagulant treatment at stroke onset |
| Recruitment start date | 01/01/2012 |
| Recruitment end date | 31/12/2020 |
Locations
Countries of recruitment
- Germany
- Switzerland
- United States of America
Study participating centres
Bern
3010
Switzerland
Basel
4031
Switzerland
Berlin
13125
Germany
6900
Switzerland
69120
Germany
91054
Germany
20052
United States of America
55131
Germany
8006
Switzerland
1011
Switzerland
RI 02903
United States of America
Sponsor information
Hospital/treatment centre
Freiburgstrasse 18
3010 Bern
Switzerland
Bern
3010
Switzerland
| Phone | +41 31 632 21 11 |
|---|---|
| david.seiffge@insel.ch | |
| Website | http://www.insel.ch/en/ |
"ROR" |
https://ror.org/01q9sj412 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/03/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request (Alexandros.Polymeris@usb.ch) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 08/04/2022 | 11/04/2022 | Yes | No |
Editorial Notes
11/04/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
08/06/2021: Trial's existence confirmed by KEK Bern.
