Safety, tolerability and recovery assessment of using sulodexide in acute ischemic stroke (STRAUSS): A pilot study

ABSTRACT

Sulodexide was evaluated in an investigator-initiated, multi-center, randomized, controlled, open-labeled study to determine its safety and tolerability profile, and effect on the neurological recovery and functional outcome of patients with acute ischemic stroke. Sixty-five (65) patients were randomized to Standard care group and 46 to Standard care plus Sulodexide Treatment group. Sulodexide was observed to be safe and well-tolerated among patients included in this study. Although not statistically significant, Modified Rankin Scale Responder Analysis consistently showed higher proportions of functionally improved patients in the Sulodexide group than in the Standard Care group on treatment days 10, 30, and 90 respectively.