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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aspirin 100mg | Experimental | Participants will be given aspirin 100mg once per day. |
|
| placebo | Placebo Comparator | Participants will be given placebo oral tablets once per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | Aspirin is one of the most widely used antithrombotic agents to prevent recurrent ischemic stroke for patients with prior symptomatic ischemic stroke. |
|
| Measure | Description | Time Frame |
|---|---|---|
| composite outcome with any incident stroke, myocardial infarction and all-cause death | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| ischemic stroke, intracranial cerebral hemorrhage, any bleeding, independence (mRS≥2) | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Sui, MD PhD | Contact | +86 24 31956417 | jakeyisui@icloud.com | |
| Ying Xiao, MMed | Contact | +86 24 31956417 | 438505109@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi Sui, MD PhD | First People's Hospital of Shenyang | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenyang Brain Hsopital | Shenyang | Liaoning | 110041 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22267825 | Background | 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. | |
| 21700935 |
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| ID | Term |
|---|---|
| D020520 | Brain Infarction |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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|
| Placebo Oral Tablet | Drug | Placebo resembling aspirin tablet will be be given to participants in control arm. |
|
| Background |
| 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. |
| 10692089 | Background | 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. |
| 24481975 | Background | 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. |
| 9823834 | Background | 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. |
| 26888534 | Background | 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. |
| 27980126 | Background | 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. |
| D009422 | Nervous System Diseases |
| D020521 | Stroke |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |