Back to resultsAntiplatelet Therapy for Silent Brain Infarction (ANTISBI)
Primary Purpose
Brain Infarction
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Aspirin
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional prevention trial for Brain Infarction focused on measuring Silent Brain Infarction, Antithrombotics, Antiplatelet, Aspirin, Asymptomatic
Eligibility Criteria
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:
- 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)
Sites / Locations
- Shenyang Brain Hsopital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
aspirin 100mg
placebo
Arm Description
Participants will be given aspirin 100mg once per day.
Participants will be given placebo oral tablets once per day.
Outcomes
Primary Outcome Measures
composite outcome with any incident stroke, myocardial infarction and all-cause death
Secondary Outcome Measures
ischemic stroke, intracranial cerebral hemorrhage, any bleeding, independence (mRS≥2)
Full Information
NCT ID
NCT03318744
First Posted
October 19, 2017
Last Updated
October 24, 2017
Sponsor
First People's Hospital of Shenyang
1. Study Identification
Unique Protocol Identification Number
NCT03318744
Brief Title
Antiplatelet Therapy for Silent Brain Infarction
Acronym
ANTISBI
Official Title
Antiplatelet Therapy in Secondary Prevention for Patient With Silent Brain Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2018 (Anticipated)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First People's Hospital of Shenyang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Infarction
Keywords
Silent Brain Infarction, Antithrombotics, Antiplatelet, Aspirin, Asymptomatic
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
aspirin 100mg
Arm Type
Experimental
Arm Description
Participants will be given aspirin 100mg once per day.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Participants will be given placebo oral tablets once per day.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
Bayaspirin
Intervention Description
Aspirin is one of the most widely used antithrombotic agents to prevent recurrent ischemic stroke for patients with prior symptomatic ischemic stroke.
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Placebo resembling aspirin tablet will be be given to participants in control arm.
Primary Outcome Measure Information:
Title
composite outcome with any incident stroke, myocardial infarction and all-cause death
Time Frame
24 months
Secondary Outcome Measure Information:
Title
ischemic stroke, intracranial cerebral hemorrhage, any bleeding, independence (mRS≥2)
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Sui, MD PhD
Phone
+86 24 31956417
Email
jakeyisui@icloud.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Xiao, MMed
Phone
+86 24 31956417
Email
438505109@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Sui, MD PhD
Organizational Affiliation
First People's Hospital of Shenyang
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shenyang Brain Hsopital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110041
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Sui, MD
Phone
+86 24 31956417
Email
jakeyisui@icloud.com
First Name & Middle Initial & Last Name & Degree
Ying Xiao, MMed
Email
438505109@qq.com
First Name & Middle Initial & Last Name & Degree
Yi Sui, MD PhD
First Name & Middle Initial & Last Name & Degree
Bing Xu, MD PhD
First Name & Middle Initial & Last Name & Degree
Jin Zhou, MD PhD
First Name & Middle Initial & Last Name & Degree
Li Li, MD PhD
First Name & Middle Initial & Last Name & Degree
Ying Xiao, MD MMed
First Name & Middle Initial & Last Name & Degree
Li Ren, MD MMed
First Name & Middle Initial & Last Name & Degree
Yunxin Zhai, MD MMed
First Name & Middle Initial & Last Name & Degree
Xia Wang, MD
First Name & Middle Initial & Last Name & Degree
Xu Wang, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
22267825
Citation
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.
Results Reference
background
PubMed Identifier
21700935
Citation
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.
Results Reference
background
PubMed Identifier
10692089
Citation
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.
Results Reference
background
PubMed Identifier
24481975
Citation
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.
Results Reference
background
PubMed Identifier
9823834
Citation
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.
Results Reference
background
PubMed Identifier
26888534
Citation
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.
Results Reference
background
PubMed Identifier
27980126
Citation
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.
Results Reference
background
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Antiplatelet Therapy for Silent Brain Infarction
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