Acute Ischemic StrokeAISWAFNCT04080830
Registration Study of Acute Ischemic Stroke/Transient Ischemic Attack (TIA) With Atrial Fibrillation
An observational study of Acute Ischemic Stroke and Atrial Fibrillation, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
Patient Registration Study of Acute Ischemic Stroke/transient ischemic attack(TIA) With Atrial Fibrillation (AISWAF) is a single-center prospective, consecutively, observational study, was conducted in patients with acute ischemic stroke/TIA with atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Ischemic Stroke, Atrial Fibrillation
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 30 Dec 2021
- How long will I take part?
- 1 Year
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute Ischemic Stroke/TIA With Atrial Fibrillation
Who may be able to join
- Age greater than or equal to 18 years old;
- Acute ischemic stroke or TIA within 14 days of onset (including patients with hemorrhagic transformation of infarction)
- Evidence of atrial fibrillation or newly discovered atrial fibrillation before onset (atrial fibrillation includes valvular and non-valvular, permanent, persistent or paroxysmal);
- Sign informed consent and consent to follow-up for 1 year.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sufang Xue
Beijing, Beijing Municipality, 100053
sufang xue, 8613810496895 ext. 8613810496895, xuesufang@xwhosp.org
sufang xue
About this study
Official title: Patient Registration Study of Acute Ischemic Stroke/Transient Ischemic Attack(TIA ) With Atrial Fibrillation
Patient Registration Study of Acute Ischemic Stroke/transient ischemic attack(TIA) With Atrial Fibrillation (AISWAF) is a single-center prospective, consecutively, observational study, was conducted in patients with acute ischemic stroke/TIA with atrial fibrillation. The aim of this study was to understand the stroke mechanism, the regularity of stroke recurrence and its influencing factors, to establish a risk stratification model for stroke recurrence, and to preliminarily explore the relationship between stroke mechanism, risk stratification and antithrombotic regimen in this population.
Read the detailed description
Patients with acute ischemic stroke (IS) and atrial fibrillation (AF) are at particularly high risk of recurrent IS and other major vascular events. Current antithrombotic therapy guidelines recommend oral anticoagulation (OAC) alone for the secondary prevention of IS in this high-risk population. However, these guidelines are largely based on evidence from randomized-controlled trials that did not include patients with acute IS. With the exception of the European Atrial Fibrillation Trial (EAFT), all randomized-controlled trials evaluating antithrombotic therapy in patients with AF included primary prevention populations. Moreover, the EAFT trial does not inform the management of patients with severe stroke, as these patients were excluded from this trial, and it did not evaluate the safety and efficacy of combination OAC and antiplatelet therapy.Current observational studies also provide very limited information about the optimal antithrombotic regimen for different stroke mechanisms in acute ischemic stroke/transient ischemic attack(TIA) with atrial fibrillation. In fact , the regularity of recurrence, the specific mechanism of ischemic stroke and the optimal antithrombotic regimen for different stroke mechanisms in these patients are still not clear, which limited clinical treatment level of these patients. Patient Registration Study of Acute Ischemic Stroke/transient ischemic attack(TIA) With Atrial Fibrillation (AISWAF) is a single-center prospective, consecutively, observational study, was conducted in patients with acute ischemic stroke/TIA with atrial fibrillation. The aim of this study was to understand the stroke mechanism, the regularity of stroke recurrence and its influencing factors, to establish a risk stratification model for stroke recurrence, and to preliminarily explore the relationship between stroke mechanism, risk stratification and antithrombotic regimen in this population.The clinical, imaging and laboratory information were collected at baseline. During the 1-year follow-up period, three months, six months and one year after admission, the patients were followed up by telephone or face-to-face to record the status of antithrombotic therapy, compliance, functional status, recurrence of ischemic stroke, intracranial hemorrhage, major extracranial hemorrhage as well as other vascular events and deaths.
- Conditions
- Acute Ischemic Stroke, Atrial Fibrillation
- Keywords
- Registration Study, Acute Ischemic Stroke, Atrial Fibrillation
- Medical subject headings
- Ischemic Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute ischemic stroke/transient ischemic attack (TIA) with AF | patients with Acute ischemic stroke/TIA and Atrial fibrillation (observational -no intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of recurrent Ischemic stroke/TIA and symptomatic systemic embolism
recurrent ischemic stroke/TIA and symptomatic systemic embolism
Measured: one year
Secondary outcomes (9)
The rate recurrent Ischemic stroke/TIA
Recurrent ischemic stroke/TIA is defined as a new focal neurological deficit of sudden onset lasting at least 24 h (or<24 h if following therapeutic intervention, i.e. thrombolysis or thrombectomy, or if the deficit results in death< 24 h), occurring>24 h after the index ischemic stroke, irrespective of vascular territory and that is not attributable to oedema, brain shift, haemorrhagic transformation, intercurrent illness, hypoxia or drug toxicity;
Measured: one year
The rate of symptomatic intracranial hemorrhage
Symptomatic intracranial hemorrhage(ICH) is defined as a new focal neurological deficit of sudden onset lasting at least 24 h with documented ICH on imaging (CT orMRI). Any intraparenchymal hematoma (≥ 10 mm) will be considered, including haemorrhagic transformation of the index ischemic stroke. However, microhaemorrhages (< 10 mm) do not fulfil the study definition of ICH. ICH will be classified as symptomatic if it is associated with≥4 points increase in total National Institutes of Health stroke scale (NIHSS) or≥2 points increase in 1 of the NIHSS categories ;
Measured: one year
The rate of non-intracranial major hemorrhage
non-intracranial major hemorrhage are those that result in death or are life-threatening as defined by the International Society on Thrombosis and Haemostasis (ISTH) or consume major healthcare resources, which include: - fatal bleeding; and/or - symptomatic bleeding in a critical area or organ, such as intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome; and/or - bleeding causing a fall in haemoglobin level of≥ 20 g/L, or leading to transfusion of two or more units of whole blood or red cells; and/or - bleeding events leading to hospitalisation (in addition to the original ISTH definition)
Measured: one year
the rate of hemorrhagic transformation and the rate of symptomatic hemorrhagic transformation
Hemorrhagic transformation (HT) was defined on CT scan as any degree of hyperdensity within the area of low attenuation and was classified as either hemorrhagic infarction or parenchymal hematoma;symptomatic haemorrhagic transformation of the index ischemic stroke which is associated with≥4 points increase in total National Institutes of Health stroke scale (NIHSS) or≥2 points increase in 1 of the NIHSS categories
Measured: one month
the rate of vascular death
vascular death is defined as the death caused by vascular events on the basis of which platelet-rich thrombi are formed
Measured: one year
All cause death
All cause death is defined as the death from various causes
Measured: one year
the rate of clinically relevant nonmajor bleeding
Clinically relevant nonmajor bleeding is defined as non major bleeding. resulting in hospitalization, medical or surgical intervention, or change, interruption, or discontinuation of the antithrombotic drug
Measured: one year
Neurological disability
Neurological disability is measured with modified ranking scale (0-5). 0:No symptoms at all; 1:Despite symptoms, it has no obvious dysfunction and can perform all daily duties and activities; 2:Mild disability, unable to complete all pre-illness activities, but without help, can take care of their own affairs;3:Moderate disability requires some help, but walking does not require help; 4:Severe disability, can not walk independently, without the help of others can not meet their own needs; 5:Severe disability, bedridden, incontinence, continuous care and attention are required.
Measured: one year
the rate of medication persistence with OAC therapy
Medication persistence with OAC therapy is defined as the absence of are fill gap of >60 days (non-persistence was defined as a gap of >60 days after the end of the day's supply of the medication of interest). Discontinuation was defined as no additional refill of the medication of interest for >90 days through to the end of follow-up.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start1 Jan 2016
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sufang Xue, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080830
- Sponsor's protocol ID
- ID-8849
- Acronym
- AISWAF
- Status last verified
- Sep 2019
- First submitted
- 3 Sep 2019
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Registration Study of Acute Ischemic Stroke/Transient Ischemic Attack(TIA ) With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04080830
- Acronym / sponsor ID
- AISWAF / ID-8849
- Conditions
- Acute Ischemic Stroke, Atrial Fibrillation
- Keywords
- Registration Study, Acute Ischemic Stroke, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patient Registration Study of Acute Ischemic Stroke/transient ischemic attack(TIA) With Atrial Fibrillation (AISWAF) is a single-center prospective, consecutively, observational study, was conducted in patients with acute ischemic stroke/TIA with atrial fibrillation. The aim of this study was to understand the stroke mechanism, the regularity of stroke recurrence and its influencing factors, to establish a risk stratification model for stroke recurrence, and to preliminarily explore the relationship between stroke mechanism, risk stratification and antithrombotic regimen in this population.
Detailed description
Patients with acute ischemic stroke (IS) and atrial fibrillation (AF) are at particularly high risk of recurrent IS and other major vascular events. Current antithrombotic therapy guidelines recommend oral anticoagulation (OAC) alone for the secondary prevention of IS in this high-risk population. However, these guidelines are largely based on evidence from randomized-controlled trials that did not include patients with acute IS. With the exception of the European Atrial Fibrillation Trial (EAFT), all randomized-controlled trials evaluating antithrombotic therapy in patients with AF included primary prevention populations. Moreover, the EAFT trial does not inform the management of patients with severe stroke, as these patients were excluded from this trial, and it did not evaluate the safety and efficacy of combination OAC and antiplatelet therapy.Current observational studies also provide very limited information about the optimal antithrombotic regimen for different stroke mechanisms in acute ischemic stroke/transient ischemic attack(TIA) with atrial fibrillation. In fact , the regularity of recurrence, the specific mechanism of ischemic stroke and the optimal antithrombotic regimen for different stroke mechanisms in these patients are still not clear, which limited clinical treatment level of these patients. Patient Registration Study of Acute Ischemic Stroke/transient ischemic attack(TIA) With Atrial Fibrillation (AISWAF) is a single-center prospective, consecutively, observational study, was conducted in patients with acute ischemic stroke/TIA with atrial fibrillation. The aim of this study was to understand the stroke mechanism, the regularity of stroke recurrence and its influencing factors, to establish a risk stratification model for stroke recurrence, and to preliminarily explore the relationship between stroke mechanism, risk stratification and antithrombotic regimen in this population.The clinical, imaging and laboratory information were collected at baseline. During the 1-year follow-up period, three months, six months and one year after admission, the patients were followed up by telephone or face-to-face to record the status of antithrombotic therapy, compliance, functional status, recurrence of ischemic stroke, intracranial hemorrhage, major extracranial hemorrhage as well as other vascular events and deaths.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute ischemic stroke/transient ischemic attack (TIA) with AF | – | –patients with Acute ischemic stroke/TIA and Atrial fibrillation (observational -no intervention) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute Ischemic Stroke/TIA With Atrial Fibrillation
Key inclusion criteria (4 listed)
- Age greater than or equal to 18 years old;
- Acute ischemic stroke or TIA within 14 days of onset (including patients with hemorrhagic transformation of infarction)
- Evidence of atrial fibrillation or newly discovered atrial fibrillation before onset (atrial fibrillation includes valvular and non-valvular, permanent, persistent or paroxysmal);
- Sign informed consent and consent to follow-up for 1 year.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The rate of recurrent Ischemic stroke/TIA and symptomatic systemic embolism
Time frame: one year
recurrent ischemic stroke/TIA and symptomatic systemic embolism
9 secondary outcomes
The rate recurrent Ischemic stroke/TIA
Time frame: one year
The rate of symptomatic intracranial hemorrhage
Time frame: one year
The rate of non-intracranial major hemorrhage
Time frame: one year
the rate of hemorrhagic transformation and the rate of symptomatic hemorrhagic transformation
Time frame: one month
the rate of vascular death
Time frame: one year
All cause death
Time frame: one year
the rate of clinically relevant nonmajor bleeding
Time frame: one year
Neurological disability
Time frame: one year
the rate of medication persistence with OAC therapy
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke and Atrial Fibrillation, run by Xuanwu Hospital, Beijing at 1 site in China.
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 1 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: status not confirmed, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sufang xue, PHD,MD (8613810496895 ext. 8613810496895, xuesufang@xwhosp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of recurrent Ischemic stroke/TIA and symptomatic systemic embolism (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2019.