The primary objective of the study will be to determine whether remote limb ischemic conditioning (RLIC) compared with sham RLIC (placebo) treatment reduces the 12-month risk of recurrent IS in patients with a recent TIA or IS caused by stenosis of a major intracranial artery. After screening period, eligible patients will be randomly allocated into 2 groups. In addition, all participants receive an usual clinical therapy.
In this study, Patients in the RLIC group will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (200mmHg) once daily for 12 months; patients in the sham RLIC group will be treated with the Renqiao Remote Ischemic Conditioning Device (Doctormate®) (60mmHg) once daily for 12 months. In the study, the RLIC treatment will be comprised of 5 cycles of bilateral upper limb ischemia and reperfusion, which will be induced by 2 cuffs placed around the upper arms respectively and inflated to 200mmHg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. Sham RLIC treatment will be conducted using the same procedure but with a minimal inflation pressure of 60mmHg, which does not result in upper limb ischemia. In addition, all participants will have received their usual drug therapy according to local medical practice.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
3,000
Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 200mmHg.
Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 60mmHg.
The time from randomization to the first occurrence of fatal or non-fatal ischemic stroke.
Time frame: During the first 12 months from randomization.
The time from randomization to the first occurrence of a composite of fatal or non-fatal stroke (ischemic and hemorrhagic), fatal or non-fatal myocardial infarction, and transient ischemic attack (TIA) .
Time frame: During the first 12 months from randomization.
The time from randomization to the first occurrence of each component of the composite of fatal or non-fatal stroke (ischemic and hemorrhagic), fatal or non-fatal myocardial infarction, and TIA.
Time frame: During the first 12 months from randomization.
Time to death from all causes from randomization.
Time frame: During the first 12 months from randomization.
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