Background：Acute minor ischemic stroke （AMIS） or transient ischemic attack （TIA） is a common cerebrovascular event with a considerable high recurrence.Prior research demonstrated the effectiveness of regular long...Background：Acute minor ischemic stroke （AMIS） or transient ischemic attack （TIA） is a common cerebrovascular event with a considerable high recurrence.Prior research demonstrated the effectiveness of regular long-term remote ischemic conditioning （RIC） in secondary stroke prevention in patients with intracranial stenosis.We hypothesized that RIC can serve as an effective adjunctive therapy to pharmacotherapy in preventing ischemic events in patients with AMIS/TIA.This study aimed to investigate the feasibility,safety,and preliminary efficacy of daily RIC in inhibiting cerebrovascular/cardiovascular events after AMIS/TIA.Methods：This is a single-arm,open-label,multicenter Phase IIa futility study with a sample size of 165.Patients with AMIS/TIA receive RIC as an additional therapy to secondary stroke prevention regimen.RIC consists of five cycles of 5-min inflation （200 mmHg） and 5-min deflation of cuffs on bilateral upper limbs twice a day for 90 days.The antiplatelet strategy is based on individual physician＇s best practice：aspirin alone,clopidogrel alone,or combination of aspirin and clopidogrel.We will assess the recurrence rate of ischemic stroke/TIA within 3 months as the primary outcomes.Conclusions：The data gathered from the study will be used to determine whether a further large-scale,multicenter randomized controlled Phase Ⅱ trial is warranted in patients with AMIS/TIA.Trial Registration：ClinicalTrials.gov,NCT03004820;https：//www.clinicaltrials.gov/ct2/show/NCT03004820.展开更多
基金PICNIC-One study is supported by the grants from the National Natural Science Foundation of China （No. 81325007 and No. 81620108011）, the Capital Health Research and Special Development （No. 2016-4-1032）, the American Stroke Association （No. 14SDG 1829003）, and the National Institute of Health （No. P20GM 109040）.
文摘Background：Acute minor ischemic stroke （AMIS） or transient ischemic attack （TIA） is a common cerebrovascular event with a considerable high recurrence.Prior research demonstrated the effectiveness of regular long-term remote ischemic conditioning （RIC） in secondary stroke prevention in patients with intracranial stenosis.We hypothesized that RIC can serve as an effective adjunctive therapy to pharmacotherapy in preventing ischemic events in patients with AMIS/TIA.This study aimed to investigate the feasibility,safety,and preliminary efficacy of daily RIC in inhibiting cerebrovascular/cardiovascular events after AMIS/TIA.Methods：This is a single-arm,open-label,multicenter Phase IIa futility study with a sample size of 165.Patients with AMIS/TIA receive RIC as an additional therapy to secondary stroke prevention regimen.RIC consists of five cycles of 5-min inflation （200 mmHg） and 5-min deflation of cuffs on bilateral upper limbs twice a day for 90 days.The antiplatelet strategy is based on individual physician＇s best practice：aspirin alone,clopidogrel alone,or combination of aspirin and clopidogrel.We will assess the recurrence rate of ischemic stroke/TIA within 3 months as the primary outcomes.Conclusions：The data gathered from the study will be used to determine whether a further large-scale,multicenter randomized controlled Phase Ⅱ trial is warranted in patients with AMIS/TIA.Trial Registration：ClinicalTrials.gov,NCT03004820;https：//www.clinicaltrials.gov/ct2/show/NCT03004820.
