r-tPA Thrombolytic Therapy in Combination With Remote Ischemic Conditioning for Acute Ischemic Stroke Recovery "rtPA-RIC"

Not yet recruiting

Phase N/A Results N/A

Trial Description

The purpose of this study is to determine whether remote limb ischemic conditioning(RIC) increase the risk of intracranial hemorrhage for the acute ischemic stroke patients who received r-tPA thrombolytic therapy.

Conditions

Interventions

  • Ischemic conditioning Device
    Other Names: Doctormate, IPC-906
    Intervention Desc: In this study, the remote ischemic conditioning treatment was composed of five cycles of bilateral upper limb ischemia intervened by reperfusion, which was induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation.
    ARM 1: Kind: Experimental
    Label: RIC group
    Description: The upper limb ischemic conditioning is composed of five cycles of bilateral upper limb ischemia intervened by reperfusion, which is induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. This therapy started within 2 hours after r-tPA thrombolytic therapy. In addition, all participants receive a standard clinical therapy.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Number of participants with intracranial hemorrhage after RIC therapy 90 days Yes
Primary objective signs of tissue or neurovascular injury 90 days Yes
Primary levels of plasma biomarkers 30 days Yes
Secondary number of participants with mRS 0-1 90 days No
Secondary Scores assessed by modified Rankin Scale(mRS) 90 days No
Secondary Scores assessed by Barthel Index(BI) 90 days No
Secondary Scores assessed by National Institutes of Health Stroke Scale(NIHSS) 90 days No
Secondary Number of participants with adverse events that are related to treatment 90 days Yes

Sponsors