Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
3400 participants
INTERVENTIONAL
2018-01-31
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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aspirin 100mg
Participants will be given aspirin 100mg once per day.
Aspirin
Aspirin is one of the most widely used antithrombotic agents to prevent recurrent ischemic stroke for patients with prior symptomatic ischemic stroke.
placebo
Participants will be given placebo oral tablets once per day.
Placebo Oral Tablet
Placebo resembling aspirin tablet will be be given to participants in control arm.
Interventions
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Aspirin
Aspirin is one of the most widely used antithrombotic agents to prevent recurrent ischemic stroke for patients with prior symptomatic ischemic stroke.
Placebo Oral Tablet
Placebo resembling aspirin tablet will be be given to participants in control arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
45 Years
80 Years
ALL
No
Sponsors
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First People's Hospital of Shenyang
OTHER
Responsible Party
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Dr. Yi Sui
Director of Neurology
Principal Investigators
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Yi Sui, MD PhD
Role: PRINCIPAL_INVESTIGATOR
First People's Hospital of Shenyang
Locations
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Shenyang Brain Hsopital
Shenyang, Liaoning, China
Countries
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Central Contacts
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Facility Contacts
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Yi Sui, MD
Role: primary
Ying Xiao, MMed
Role: backup
References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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FirstPHShenyang
Identifier Type: -
Identifier Source: org_study_id