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Acute Ischemic StrokeNCT06548269

Multimodal Prognostic Assessment of Acute Ischemic Stroke Patients With Atrial Fibrillation: a Prospective, Multicenter, Observational Study (IAT-CLOSURE)

An observational study of Acute Ischemic Stroke and Atrial Fibrillation, run by Jinan Central Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The main purpose of this study is to investigate the safety and outcomes of different treatment strategies, including best medical therapy (OAC [oral anticoagulation], antiplatelet [APT]) and left atrial appendage closure [LAAC] in acute ischemic stroke (AIS) patients with atrial fibrillation (AF) based on multimodal… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Ischemic Stroke, Atrial Fibrillation
What is being tested?
Cardiologic work-up
How many people
1,000 participants
Where
1 siteChina
Study dates
15 Nov 2024to 31 May 2029
How long will I take part?
3 Years
Phase
Observational
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients who had acute ischemic stroke symptoms within 7 days and previously or during this hospitalization diagnosed with non-valvular atrial fibrillation.

Who may be able to join

  • Age > 18 years old;
  • Acute ischemic stroke with onset ≤ 14 days;
  • Previously or during this hospitalization diagnosed with non-valvular atrial fibrillation;
  • Informed consent obtained from the patient or his/her legal representative;

Who cannot join

  • Pacemaker, implantable cardioverter defibrillator or implantable cardiac monitor;
  • Left atrial appendage has been removed or post occlusion device implantation;
  • Transient AF secondary to other reversible disorders;
  • Life expectancy less than 1 year;
  • Patients that cannot complete subsequent follow-up (e.g. no fixed residence, overseas patients, etc.);
  • Females who are pregnant or in lactation;
  • Participating in other clinical trials that could confound the evaluation of the study;
  • Other circumstances that the investigator considers inappropriate for participation or may pose a significant risk to patients.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • Jinan Central Hospital

    Jinan, Shandong, 250013

    Yanxin Zhao, +86 13370582882, 13370582882@163.com

    Wencheng Kong, +86 15614656050, kongwencheng@163.com

    Recruiting

Other trials in China

About this study

The main purpose of this study is to investigate the safety and outcomes of different treatment strategies, including best medical therapy (OAC [oral anticoagulation], antiplatelet [APT]) and left atrial appendage closure [LAAC] in acute ischemic stroke (AIS) patients with atrial fibrillation (AF) based on multimodal assessment from combined brain and cardiologic work-up, and to optimize secondary prevention.

Read the detailed description

Ischemic stroke is the leading cause of disability and mortality globally. Atrial fibrillation(AF) is a well-established risk factor for ischemic stroke and responsible for up to one-third of all strokes. AF-related ischemic strokes are more frequently fatal or disabling than non-AF strokes. The overall prevalence of known or newly diagnosed AF in stroke patients is approximately 39.0%. Detecting underlying AF remains important for secondary prevention of recurrent stroke, with a different strategy from atherosclerotic cause of stroke. The increasingly common use of prolonged cardiac monitoring (PCM) after ischemic stroke has greatly increased the detection rates of previously undiagnosed AF in ischemic strokes, which was demonstrated by a series of trials. Additionally, AF burden, defined as percentage of the time in AF during cardiac monitoring, has been regarded as an important prognostic risk factor for thromboembolism.

Currently, the CHA2DS2-VASc score is the most widely used scoring system for assessing ischemic stroke risk in patients with AF and basis for initiation of anticoagulation. Anticoagulation is currently recommended for male with CHA2DS2-VASc score≥2 or female with CHA2DS2-VASc score≥3. Direct oral anticoagulants (DOACs) have been increasingly used in the past decade due to their similar to superior efficacy to vitamin K antagonists (VKAs), but a lower intracerebral bleeding risk in non-valvular atrial fibrillation (NVAF), defined as AF in the absence of moderate to severe mitral stenosis or a mechanical heart valve. For patients with AF who cannot tolerate long-term OACs due to various relative or absolute contraindications, left atrial appendage closure (LAAC) offers an alternative treatment strategy for these patients. Moreover, as one-third of patients with ischemic stroke and AF may have concomitant large artery atherosclerosis or small vessel disease, it is still unclear whether these patients should be left untreated or treated with antiplatelet (APT), DOACs, or with LAAC.

Traditional clinical practice mainly focuses on the presence of AF but rarely incorporates AF burden into a risk stratification scoring system. To our knowledge, no studies to date have investigated recurrent stroke risk stratification in AIS patients with AF based on AF burden assessed by PCM, not to mention guidance of treatment strategy selection. Further, other multimodal assessments, such as cerebral CT/MRI (e.g. infarct size and location), serum biomarkers (e.g. BNP, troponin, D-dimer levels) and cardiac structural markers (e.g. LA volume or volume index, LAA morphologies) have been reported as promising prognostic factors of stroke severity and recurrence. A comprehensive evaluation system is still lacking. In this prospective and multicenter registry study, we determine to test the safety and effectiveness of best medical therapy (OAC, APT) and LAAC using multimodal assessment from combined brain and cardiologic work-up, with the aim to optimize secondary prevention in this patient population.

Being tested
Cardiologic work-up
Keywords
Acute Ischemic Stroke, Atrial fibrillation, AF burden, Left atrial appendage closure
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.

  • Cardiologic work-upDiagnostic test

    Noninvasive prolonged ECG monitoring with a duration of 7 days measuring AF burden; Echocardiography measuring LA volume or volume index, LA diameter or diameter index; Cardiac CTA measuring LAA morphologies, cardiac thrombus.

Study groups in NCT06548269
Study groupRoleWhat they receive
Patients with acute ischemic stroke and atrial fibrillationAdult patients with an acute ischemic stroke and atrial fibrillation will undergo a baseline work-up and cardiologic work-up. Baseline work-up includes admission 12-lead ECG,blood analysis, brain CT/MRI, brain CTA/MRA/vessel ultrasound. Cardiologic work-up includes prolonged ECG monitoring, echocardiography and cardiac CTA. Treatment will follow the current guidelines.
Receives: Diagnostic Test: Cardiologic work-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite endpoints of ischemic stroke, systemic embolism, myocardial infarction, major bleeding (BARC type 3-5) and all-cause mortality

    Stroke only including ischemic stroke

    Measured: 1 year

Secondary outcomes (1)
  1. Composite endpoints of stroke, systemic embolism, myocardial infarction, major bleeding (BARC type 3-5) and all-cause mortality

    Stroke including ischemic or hemorrhagic stroke

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2024
  2. Study start15 Nov 2024
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 May 2029 (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
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06548269
Sponsor's protocol ID
IAT-CLOSURE
Status last verified
Dec 2024
First submitted
7 Aug 2024
Last updated
22 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Ischemic Stroke and Atrial Fibrillation, run by Jinan Central Hospital 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 8 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: looking for participants now, as of the sponsor's last update on 22 May 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Liqun Jiao (13911224991, liqunjiao@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite endpoints of ischemic stroke, systemic embolism, myocardial infarction, major bleeding (BARC type 3-5) and all-cause mortality (time frame: 1 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 22 May 2025.

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