Atrial fibrillation in stroke - Utility of Neuroimaging Evaluation
| ISRCTN | ISRCTN44617730 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44617730 |
| Secondary identifying numbers | 2015-11-23 NOAC registry ATTUNE_v1.4.1final |
- Submission date
- 08/05/2018
- Registration date
- 15/05/2018
- Last edited
- 21/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Patients who have had a stroke are at a higher risk of having further strokes if they suffer from an abnormal rhythm of the heart (atrial fibrillation). Research suggests that beginning therapy that reduces this risk of recurrent stroke should be done within 48 hours of the stroke. However, one of the risks of this therapy is that it causes an increased risk of bleeding in the area of the brain damaged by the stroke. If this occurs, the patient has a much higher risk of poor stroke outcome and death. The purpose of this research is to improve our understanding of the timing of initiation of blood-thinning therapy in stroke patients who have an abnormal rhythm of the heart (atrial fibrillation.
To do this we are observing patients in the hospital clinical setting who begin their anticoagulant (drug that prevents blood clotting) therapy within 7 days from their stroke or after 7 days from their stroke onset. We aim to measure evidence of new "recurrent" stroke as well as any bleeding events patients may have had at 90 days after the initial stroke. We aim to compare whether it is better for patients to receive this therapy within 7 days from their stroke or after 7 days.
Who can participate?
Adults who have had a stroke related to atrial fibrillation and have been treated with anticoagulants with 1 month of their stroke.
What does the study involve?
This is an observational study, which means that participants will receive usual treatment. Participants will have an additional MRI scan at 3 months after recruitment.
What are the possible benefits and risks of participating?
We cannot guarantee or promise that participants will receive any benefits from this project. MRI imaging is a very safe assessment for most patients, as it does not use radioactive substances. However, patients with heart pacemakers and other metallic surgical implants, for example a cochlear implant, cannot be scanned. Participants will be asked a safety questionnaire before their scan to ensure it is safe to be scanned. There are no other associated risks from participating in this study. Patients do not have to participate in this research project to receive any medical care that may be required. If patients choose not to participate they will receive the standard care that is given to patients experiencing stroke.
Where is the study run from?
Royal Melbourne Hospital
When is the study starting and how long is it expected to run for?
May 2016 to April 2022 (updated 21/05/2019, previously: February 2019)
Who is funding the study?
The Australasian Stroke Academy
Who is the main contact?
Miss Christina Lam,
Christina.lam@mh.org.au
Contact information
Scientific
Department of Neurology, Melbourne Brain Centre, Royal Melbourne Hospital
300 Grattan Street
Melbourne
3050
Australia
Public
Melbourne Brain Centre
Level 4, Royal Melbourne Hospital
300 Grattan Street
Parkville
3050
Australia
| Phone | +61 410 858 739 |
|---|---|
| Christina.lam@mh.org.au |
Study information
| Study design | Prospective observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | A registry of clinical and MRI outcomes following early versus late initiation of anticoagulation after ischaemic stroke or transient ischaemic attack in patients with atrial fibrillation |
| Study acronym | ATTUNE |
| Study objectives | 1. Patients initiated on NOACs within 7 days of the stroke/TIA will have less recurrent infarction than patients initiated more than 7 days after their stroke/TIA 2. There will be no difference in haemorrhagic transformation (HT) or new intra-cerebral haemorrhage (ICH) in patients initiated on NOAC within 7 days of the stroke/TIA compared to initiation after 7 days 3. Patients initiated on NOAC within 7 days of the stroke/TIA will have fewer recurrent ischaemic events than patients initiated after 7 days 4. Early (<7 day) administration of oral anticoagulation will associate with a favorable overall cost-benefit ratio |
| Ethics approval(s) | Hunter New England Human Research Ethics Committee, 12/04/2016, 16/02/17/4.01 |
| Health condition(s) or problem(s) studied | Acute ischaemic stroke |
| Intervention | This is a prospective, 3-month observational cohort study using an established clinico-radiological stroke registry to examine clinical and MR imaging outcomes of patients initiated on novel oral anticoagulants (NOACs), including apixaban, rivaroxaban and dabigatran (note that edoxaban is currently unavailable in Australia) or vitamin K antagonists (VKAs), eg warfarin, within 1 month after acute stroke or transient ischaemic attack (TIA). Subjects will be analysed according to whether anticoagulant initiation was within 7 days, or after 7 days of stroke symptom onset. As this is an observational cohort study, patients undergo usual care, and the decision of when and what type of oral anticoagulant used is at the discretion of the treating clinician. Clinical data will include: patient demographics, pre-stroke history, previous medication history, in-hospital data (baseline and 24-hour National Institute of Health Stroke Score), reperfusion treatment, antiplatelet and anticoagulant treatment post stroke, recurrent stroke and other adverse events. Follow-up information includes clinical evidence of recurrent ischaemic stroke, TIA, intracerebral haemorrhage (ICH), and the 3-month modified Rankin scale (mRS). 3-month outcomes will be recorded centrally by phone call from the coordinating centre. This includes a scripted, validated mRS assessment. Central Review of Imaging All imaging will be reviewed by principal investigators of the study. Investigators will be blinded to both anticoagulation type (NOAC versus warfarin) and time frame for initiation. Imaging review will follow a proforma that assesses ischaemic change as well as ICH. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Warfarin, novel oral anticoagulants (NOACs) including apixaban, rivaroxaban and dabigatran |
| Primary outcome measure | New ischaemic lesions on MRI at 1 month |
| Secondary outcome measures | 1. New clinical stroke within 90 days determined by clinic review or telephone follow up 2. Intracerebral haemorrhage on MRI at 1 month 3. Disability or dependence following stroke, assessed by mRS at 90 days determined by clinic review or telephone follow up 4. Non-intracranial bleeding within 90 days |
| Overall study start date | 12/06/2015 |
| Completion date | 01/04/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 280 |
| Key inclusion criteria | 1. Patients who present with an acute ischaemic stroke or TIA of cardioembolic (atrial fibrillation [AF]-related) origin and who have an MRI following their primary ischaemic event, and are deemed suitable for initiation of NOAC or VKA therapy 2. Subjects must be enrolled within 30 days of symptom onset |
| Key exclusion criteria | 1. Evidence of primary intracranial haemorrhage 2. Inability to have baseline and follow-up MRI |
| Date of first enrolment | 21/05/2016 |
| Date of final enrolment | 01/01/2022 |
Locations
Countries of recruitment
- Australia
Study participating centres
Melbourne
3050
Australia
Australia
Australia
Australia
Australia
Australia
Australia
Australia
Australia
Australia
Australia
Australia
Australia
Australia
Australia
Australia
Australia
Australia
Australia
Sponsor information
Research organisation
PO Box 316 Stepney South Australia 5069
South Australia
5069
Australia
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 01/04/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
21/05/2019: The following changes were made to the trial record:
1. The intention to publish date was changed from 01/02/2020 to 01/04/2023.
2. The overall end date was changed from 01/02/2019 to 01/04/2022.
3. The plain English summary was updated to reflect these changes.
19/11/2018: The following changes have been made:
1. The recruitment end date has been changed from 01/11/2018 to 01/01/2022.
2. Christina Lam has been added as the public contact and has replaced Jillian Naylor as the main contact in the plain English summary.
