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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • Sufang Xue

    Beijing, Beijing Municipality, 100053

    sufang xue, 8613810496895 ext. 8613810496895, xuesufang@xwhosp.org

    sufang xue

    Recruiting

Other trials in China

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.

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 groups in NCT04080830
Study groupRoleWhat they receive
Acute ischemic stroke/transient ischemic attack (TIA) with AFpatients 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. All cause death

    All cause death is defined as the death from various causes

    Measured: one year

  7. 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

  8. 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

  9. 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.

  1. First posted6 Sep 2019
  2. Study start1 Jan 2016
  3. Primary completion30 Dec 2021 (estimated)
  4. Study completion30 Dec 2021 (estimated)

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
1,000 participants (estimated)
Target duration
1 Year
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

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.

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