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Antiplatelet Therapy for Silent Brain Infarction (ANTISBI)

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ClinicalTrials.gov Identifier: NCT03318744
Recruitment Status : Not yet recruiting
First Posted : October 24, 2017
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Yi Sui, First People's Hospital of Shenyang

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.

Condition or disease Intervention/treatment Phase
Brain Infarction Drug: Aspirin Drug: Placebo Oral Tablet Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Antiplatelet Therapy in Secondary Prevention for Patient With Silent Brain Infarction
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: aspirin 100mg
Participants will be given aspirin 100mg once per day.
Drug: Aspirin
Aspirin is one of the most widely used antithrombotic agents to prevent recurrent ischemic stroke for patients with prior symptomatic ischemic stroke.
Other Name: Bayaspirin

Placebo Comparator: placebo
Participants will be given placebo oral tablets once per day.
Drug: Placebo Oral Tablet
Placebo resembling aspirin tablet will be be given to participants in control arm.




Primary Outcome Measures :
  1. composite outcome with any incident stroke, myocardial infarction and all-cause death [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. ischemic stroke, intracranial cerebral hemorrhage, any bleeding, independence (mRS≥2) [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03318744


Contacts
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Contact: Yi Sui, MD PhD +86 24 31956417 jakeyisui@icloud.com
Contact: Ying Xiao, MMed +86 24 31956417 438505109@qq.com

Locations
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China, Liaoning
Shenyang Brain Hsopital Not yet recruiting
Shenyang, Liaoning, China, 110041
Contact: Yi Sui, MD    +86 24 31956417    jakeyisui@icloud.com   
Contact: Ying Xiao, MMed       438505109@qq.com   
Principal Investigator: Yi Sui, MD PhD         
Sub-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         
Sponsors and Collaborators
First People's Hospital of Shenyang
Investigators
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Principal Investigator: Yi Sui, MD PhD First People's Hospital of Shenyang

Publications:

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Responsible Party: Dr. Yi Sui, Director of Neurology, First People's Hospital of Shenyang
ClinicalTrials.gov Identifier: NCT03318744     History of Changes
Other Study ID Numbers: FirstPHShenyang
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Yi Sui, First People's Hospital of Shenyang:
Silent Brain Infarction
Antithrombotics
Antiplatelet
Aspirin
Asymptomatic

Additional relevant MeSH terms:
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Infarction
Brain Infarction
Ischemia
Pathologic Processes
Necrosis
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics