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
|Condition or disease||Intervention/treatment||Phase|
|Brain Infarction||Drug: Aspirin Drug: Placebo Oral Tablet||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Experimental: aspirin 100mg
Participants will be given aspirin 100mg once per day.
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.
- composite outcome with any incident stroke, myocardial infarction and all-cause death [ Time Frame: 24 months ]
- ischemic stroke, intracranial cerebral hemorrhage, any bleeding, independence (mRS≥2) [ Time Frame: 24 months ]
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
|Contact: Yi Sui, MD PhD||+86 24 email@example.com|
|Contact: Ying Xiao, MMed||+86 24 firstname.lastname@example.org|
|Shenyang Brain Hsopital|
|Shenyang, Liaoning, China, 110041|
|Contact: Yi Sui, MD +86 24 31956417 email@example.com|
|Contact: Ying Xiao, MMed firstname.lastname@example.org|
|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|
|Principal Investigator:||Yi Sui, MD PhD||First People's Hospital of Shenyang|