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Status unknownNCT03318744ANTISBIUpdated Oct 25, 2017

Antiplatelet Therapy for Silent Brain Infarction

An interventional study of Aspirin and Placebo Oral Tablet in Brain Infarction, sponsored by First People's Hospital of Shenyang. Status unknown at 1 site in China. Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-10-25.

Sponsored by First People's Hospital of Shenyang · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
3,400
Allocation
Randomized
Ages
45 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Brain Infarction

Keywords

  • Silent Brain Infarction
  • Antithrombotics
  • Antiplatelet
  • Aspirin
  • Asymptomatic
03

Who can participate

Ages eligible
45 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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)
  • 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)
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
3,400 participants (estimated)

Study arms

  • Experimental
    aspirin 100mg

    Participants will be given aspirin 100mg once per day.

    Drug: Aspirin

  • Placebo comparator
    placebo

    Participants will be given placebo oral tablets once per day.

    Drug: Placebo Oral Tablet

Interventions

  • DrugAspirin

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

    Also known as: Bayaspirin

  • DrugPlacebo Oral Tablet

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

05

What researchers measure

Primary outcomes

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

    Time frame: 24 months

Secondary outcomes

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

    Time frame: 24 months

06

Study locations

1 site
  • Shenyang Brain Hsopital
    Shenyang, Liaoning 110041, China
    • Yi Sui, MD · Contact · jakeyisui@icloud.com · +86 24 31956417
    • Ying Xiao, MMed · Contact · 438505109@qq.com
    • Yi Sui, MD PhD · Principal investigator
    • Bing Xu, MD PhD · Sub investigator
    • Jin Zhou, MD PhD · Sub investigator
    • Li Li, MD PhD · Sub investigator
    • Ying Xiao, MD MMed · Sub investigator
    • Li Ren, MD MMed · Sub investigator
    • Yunxin Zhai, MD MMed · Sub investigator
    • Xia Wang, MD · Sub investigator
    • Xu Wang, MD · Sub investigator
07

References and documents

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 ↗

Individual participant data

Plan to share: Yes

08

Registry details

Key details

Study ID
NCT03318744
Lead sponsor
First People's Hospital of Shenyang
Responsible party
Dr. Yi Sui (Director of Neurology, First People's Hospital of Shenyang) — Principal investigator
First posted
Oct 24, 2017
Start date
Jan 2018 (estimated)
Primary completion
Jul 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Oct 25, 2017

Study contacts

Yi Sui, MD PhD
Contact
jakeyisui@icloud.com
+86 24 31956417
Ying Xiao, MMed
Contact
438505109@qq.com
+86 24 31956417
Yi Sui, MD PhD
principal investigator · First People's Hospital of Shenyang

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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