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Brain InfarctionANTISBINCT03318744

Antiplatelet Therapy for Silent Brain Infarction

A study testing Aspirin in people with Brain Infarction, run by First People's Hospital of Shenyang 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Silent brain infarction (SBI) or incidental infarct is common. Recent studies revealed individuals with SBI have an increased risk of future stroke. Even though the 2014 AHA/ASA recommendation for ischemic stroke and transient ischemic attack considered SBI as an entry point for secondary prevention, convincing… Read more about this study

Who is it for?
Ages 45 to 80 years
Conditions the study is for
Brain Infarction
What is being tested?
Aspirin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,400 participants
Where
1 siteChina
Study dates
Jan 2018to Dec 2021
Phase
Interventional
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 45 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • cerebral infarction(s) identified by CT/MRI (≥ 3mm in diameter)
  • absence of signs or symptoms of neurological dysfunction ascribed to the lesion(s)
  • absence of PMH of neurological dysfunctions due to CNS lesion(s)

Who cannot join

  • Age under 45 years or above 80 years
  • PMH of ICH within 180 days
  • PMH of lobar hemorrhage of anytime
  • Neuroimaging evidence suggesting cerebral microbleeds
  • High risk of bleeding (e.g. recurrent gastrointestinal or genitourinary bleeding, active peptic ulcer disease)
  • Anticipated requirement for long-term use (more than 28 days) of anticoagulants (e.g. recurrent deep vein thrombosis)
Show all 23Show fewer
  • Prior long-term use of anticoagulants (more than 28 days) or antiplatelet agents (more than 28 days)
  • Prior retinal stroke/TIA (diagnosed either clinically or by imaging)
  • Intolerance or contraindications to aspirin (including thrombocytopenia, prolonged INR)
  • Prior ipsilateral carotid endarterectomy/stent
  • Stenosis of culprit artery ≥ 70% (detected by ultrasound, MRA, CTA or DSA)
  • Atrial fibrillation, or acute myocardial infarction, or acute congestive heart failure
  • Impaired renal function: glomerular filtration rate<60
  • Mini Mental Status Examination score<24 (adjusted for age and education)
  • Medical contraindication to MRI
  • Pregnancy or women of child-bearing potential who are not following an effective method of contraception
  • Unable or unwilling to provide informed consent
  • Unlikely to be compliant with therapy/unwilling to return for frequent clinic visits
  • Patients concurrently participating in another study with an investigational drug or device
  • Independence ascribed to limb deformity or prior disability
  • Acute myocardial infarction
  • Acute congestive heart failure
  • Other anticipated reasons for future application of antiplatelet agents other than aspirin (eg. recent stenting, interventional surgeries, Lower-Extremity Atherosclerotic Arterial Disease etc)

Trial locations and contacts

1 site in 1 country.

Yi Sui, MD PhD contact

+86 24 31956417

jakeyisui@icloud.com

Ying Xiao, MMed contact

+86 24 31956417

438505109@qq.com

China1 site

  • Shenyang Brain Hsopital

    Shenyang, Liaoning, 110041

    Yi Sui, MD, +86 24 31956417, jakeyisui@icloud.com

    Ying Xiao, MMed, 438505109@qq.com

Other trials in China

About this study

Official title: Antiplatelet Therapy in Secondary Prevention for Patient With Silent Brain Infarction

Silent brain infarction (SBI) or incidental infarct is common. Recent studies revealed individuals with SBI have an increased risk of future stroke. Even though the 2014 AHA/ASA recommendation for ischemic stroke and transient ischemic attack considered SBI as an entry point for secondary prevention, convincing evidence with regard to the preventive efficacy of antiplatelet therapy against incident stroke in SBI is scant. Investigators examine if antiplatelet therapy can effectively decrease the incidence of future stroke in SBI individuals.

Read the detailed description

SBI is defined as a focal hyperintense lesion on T2-weighted images and/or fluid-attenuated inversion recovery with no corresponding symptoms in the clinical history of the patient that could be attributed to the lesion. SBI were distinguished from nonspecific subcortical and periventricular white matter lesions by the presence of a corresponding hypointense lesion on T1-weighted images.

The prevalence of SBI varies from 5% to 62% in healthy population. To date, few studies investigate the association between SBI and ethnicity. The effectiveness of antithrombotics including aspirin against future symptomatic stroke in SBI patients remains to be established. Due to the high prevalence of ICAS among Chinese, and its nature of artery-to-artery microembolisms, investigators hypothesize that the prevalence of SBI among Chinese might be significantly higher than other races such as Caucasians and African-Americans.

Recent study has revealed that SBI is associated with an 2-fold increase of future ischemic stroke. Yet, interventions such as antiplatelet therapies for reducing the stroke risk in SBI patients have not been investigated to our best knowledge. In this study, investigators examine whether regular oral aspirin can reduce the incidence of cerebrovascular events and mortality in SBI patients.

Being tested
Aspirin, Placebo Oral Tablet
Keywords
Silent Brain Infarction, Antithrombotics, Antiplatelet, Aspirin, Asymptomatic
Medical subject headings
Brain Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AspirinDrug

    Also called Bayaspirin

    Aspirin is one of the most widely used antithrombotic agents to prevent recurrent ischemic stroke for patients with prior symptomatic ischemic stroke.

  • Placebo Oral TabletDrug

    Placebo resembling aspirin tablet will be be given to participants in control arm.

Study groups in NCT03318744
Study groupRoleWhat they receive
aspirin 100mgExperimentalParticipants will be given aspirin 100mg once per day.
Receives: Drug: Aspirin
placeboPlacebo comparatorParticipants will be given placebo oral tablets once per day.
Receives: Drug: Placebo Oral Tablet

What is being measured

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

  1. composite outcome with any incident stroke, myocardial infarction and all-cause death

    Measured: 24 months

Secondary outcomes (1)

  1. ischemic stroke, intracranial cerebral hemorrhage, any bleeding, independence (mRS≥2)

    Measured: 24 months

Timeline

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

  1. First posted24 Oct 2017
  2. Study startJan 2018 (estimated)
  3. Primary completionJul 2021 (estimated)
  4. Study completionDec 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
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03318744
Sponsor's protocol ID
FirstPHShenyang
Acronym
ANTISBI
Status last verified
Oct 2017
First submitted
19 Oct 2017
Last updated
25 Oct 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Weber R, Weimar C, Wanke I, Moller-Hartmann C, Gizewski ER, Blatchford J, Hermansson K, Demchuk AM, Forsting M, Sacco RL, Saver JL, Warach S, Diener HC, Diehl A; PRoFESS Imaging Substudy Group. Risk of recurrent stroke in patients with silent brain infarction in the Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) imaging substudy. Stroke. 2012 Feb;43(2):350-5. doi: 10.1161/STROKEAHA.111.631739. Epub 2012 Jan 19.

    PubMed 22267825

  • Chou CC, Lien LM, Chen WH, Wu MS, Lin SM, Chiu HC, Chiou HY, Bai CH. Adults with late stage 3 chronic kidney disease are at high risk for prevalent silent brain infarction: a population-based study. Stroke. 2011 Aug;42(8):2120-5. doi: 10.1161/STROKEAHA.110.597930. Epub 2011 Jun 23.

    PubMed 21700935

  • Nakagawa T, Sekizawa K, Nakajoh K, Tanji H, Arai H, Sasaki H. Silent cerebral infarction: a potential risk for pneumonia in the elderly. J Intern Med. 2000 Feb;247(2):255-9. doi: 10.1046/j.1365-2796.2000.00599.x.

    PubMed 10692089

  • Wang Y, Zhao X, Liu L, Soo YO, Pu Y, Pan Y, Wang Y, Zou X, Leung TW, Cai Y, Bai Q, Wu Y, Wang C, Pan X, Luo B, Wong KS; CICAS Study Group. Prevalence and outcomes of symptomatic intracranial large artery stenoses and occlusions in China: the Chinese Intracranial Atherosclerosis (CICAS) Study. Stroke. 2014 Mar;45(3):663-9. doi: 10.1161/STROKEAHA.113.003508. Epub 2014 Jan 30.

    PubMed 24481975

  • Caplan LR, Hennerici M. Impaired clearance of emboli (washout) is an important link between hypoperfusion, embolism, and ischemic stroke. Arch Neurol. 1998 Nov;55(11):1475-82. doi: 10.1001/archneur.55.11.1475.

    PubMed 9823834

  • Gupta A, Giambrone AE, Gialdini G, Finn C, Delgado D, Gutierrez J, Wright C, Beiser AS, Seshadri S, Pandya A, Kamel H. Silent Brain Infarction and Risk of Future Stroke: A Systematic Review and Meta-Analysis. Stroke. 2016 Mar;47(3):719-25. doi: 10.1161/STROKEAHA.115.011889.

    PubMed 26888534

  • Smith EE, Saposnik G, Biessels GJ, Doubal FN, Fornage M, Gorelick PB, Greenberg SM, Higashida RT, Kasner SE, Seshadri S; American Heart Association Stroke Council; Council on Cardiovascular Radiology and Intervention; Council on Functional Genomics and Translational Biology; and Council on Hypertension. Prevention of Stroke in Patients With Silent Cerebrovascular Disease: A Scientific Statement for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2017 Feb;48(2):e44-e71. doi: 10.1161/STR.0000000000000116. Epub 2016 Dec 15.

    PubMed 27980126

Questions about this trial

What is this clinical trial studying?

A study testing Aspirin in people with Brain Infarction, run by First People's Hospital of Shenyang 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 3 inclusion and 23 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 25 Oct 2017. 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. Some participants in this study may receive a placebo. 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 Yi Sui, MD PhD (+86 24 31956417, jakeyisui@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

composite outcome with any incident stroke, myocardial infarction and all-cause death (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03318744, which also lists 7 linked publications.

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 25 Oct 2017.

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