Safety and efficacy of remote ischemic conditioning combined with intravenous thrombolysis for acute ischemic stroke: A multicenter,randomized,parallel-controlled clinical trial (SERIC-IVT) Study design and protocol

Abstract

Rationale:

Remote ischemic conditioning (RIC) combined with intravenous thrombolysis (IVT) may improve functional outcomes in patients with acute ischemic stroke (AIS).

Aim:

To assess the efficacy and safety of RIC combined with IVT for AIS.

Methods and design:

SERIC-IVT is a multicenter, randomized, parallel-controlled, blinded endpoint clinical trial. A total of 558 patients with AIS who underwent IVT therapy will be randomly assigned 1:1 to receive RIC or sham-RIC plus standard medical therapy. The cuff pressures of the RIC group and the sham-RIC group will be 200 mm Hg and 60 mm Hg, respectively, performed twice a day for seven consecutive days.

Study outcomes:

The primary efficacy outcome is the proportion of patients with a favorable functional outcome as defined as a modified Rankin Scale ⩽ 1 at 90 days. Safety outcomes include mortality and adverse events within 90 days.

Sample size estimates:

A sample size of 558 patients with AIS (279 in each group) will allow detection of a shift of 13.14% toward favorable functional outcome at 90 days (modified Rankin Scale ⩽ 1) with 5% significance and 80% power.

Discussion:

RIC is a promising adjuvant treatment for AIS. SERIC-IVT will inform on whether RIC treatment combined with IVT improves functional outcomes in AIS patients and identify any safety issues.