Registration Study of Acute Ischemic Stroke/Transient Ischemic Attack (TIA) With Atrial Fibrillation (AISWAF)

September 6, 2019 updated by: Sufang Xue, Xuanwu Hospital, Beijing

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Recruiting
        • Sufang Xue
        • Contact:
        • Principal Investigator:
          • sufang xue
        • Sub-Investigator:
          • HaiQing Song
        • Sub-Investigator:
          • Fei chen
        • Sub-Investigator:
          • Jing Dong
        • Sub-Investigator:
          • Xin Ma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Acute Ischemic Stroke/TIA With Atrial Fibrillation

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Acute ischemic stroke/transient ischemic attack (TIA) with AF
patients with Acute ischemic stroke/TIA and Atrial fibrillation (observational -no intervention)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The rate of recurrent Ischemic stroke/TIA and symptomatic systemic embolism
Time Frame: one year
recurrent ischemic stroke/TIA and symptomatic systemic embolism
one year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The rate recurrent Ischemic stroke/TIA
Time Frame: one year
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;
one year
The rate of symptomatic intracranial hemorrhage
Time Frame: one year
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 ;
one year
The rate of non-intracranial major hemorrhage
Time Frame: one year
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)
one year
the rate of hemorrhagic transformation and the rate of symptomatic hemorrhagic transformation
Time Frame: one month
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
one month
the rate of vascular death
Time Frame: one year
vascular death is defined as the death caused by vascular events on the basis of which platelet-rich thrombi are formed
one year
All cause death
Time Frame: one year
All cause death is defined as the death from various causes
one year
the rate of clinically relevant nonmajor bleeding
Time Frame: one year
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
one year
Neurological disability
Time Frame: one year
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.
one year
the rate of medication persistence with OAC therapy
Time Frame: one year
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.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xuanwu Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ID-8849

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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