Rationale and Study Design for a Single-Arm Phase IIa Study Investigating Feasibility of Preventing Ischemic Cerebrovascular Events in High-Risk Patients with Acute Non-disabling Ischemic Cerebrovascular Events Using Remote Ischemic Conditioning.

Shi-meng Liu; Wen-le Zhao; Hai-qing Song; Ran Meng; Si-jie LI; Chang-hong Ren; Bruce Ovbiagele; Xun-ming JI; Wu-wei Feng

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Rationale and Study Design for a Single-Arm Phase IIa Study Investigating Feasibility of Preventing Ischemic Cerebrovascular Events in High-Risk Patients with Acute Non-disabling Ischemic Cerebrovascular Events Using Remote Ischemic Conditioning.

Author: Shi-Meng LIU ¹ ; Wen-Le ZHAO ² ; Hai-Qing SONG ¹ ; Ran MENG ¹ ; Si-Jie LI ³ ; Chang-Hong REN ³ ; Bruce OVBIAGELE ⁴ ; Xun-Ming JI ⁵ ; Wu-Wei FENG ⁴
Author Information

1. Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.
2. Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC 29403, USA.
3. Beijing Key Laboratory of Hypoxia Conditioning Translational Medicine, Beijing 100053, China.
4. Department of Neurology, Medical University of South Carolina, Charleston, SC 29403, USA.
5. Department of Neurology, Xuanwu Hospital, Capital Medical University
Publication Type:Journal Article
From: Chinese Medical Journal 2018;131(3):347-351
CountryChina
Language:English
Abstract:
BACKGROUNDAcute 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.
METHODSThis 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.
CONCLUSIONSThe 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 REGISTRATIONClinicalTrials.gov, NCT03004820; https://www.clinicaltrials.gov/ct2/show/NCT03004820.