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.

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.