International Journal of Stroke ( IF 6.3 ) Pub Date : 2021-04-20 , DOI: 10.1177/17474930211014344 Lu Zhao 1 , Chenyang Jiang 1 , Yongli Tao 1 , Yuan Gao 1 , Yafang Xu 1 , Rui Zhang 1 , Kai Liu 1 , Hongqiu Gu 2 , Yilong Wang 2 , Yuming Xu 1 , Bo Song 1
Rationale: Minor ischemic stroke attack has taken a significant part of cerebrovascular disease burden. Benefits of thrombolysis in minor stroke is under debates and the use of urokinase in developing countries needs to be further explored.
Aim: TRUST (ThRombolysis of Urokinase for minor STroke) trial was designed to evaluate the efficacy and safety of intravenous urokinase for the treatment of acute minor ischemic stroke.
Sample size estimates: To reach a double-sided type I error rate of 0.05 to test our hypothesis, with β=0.80, sample size of 1002 subjects were determined after further adjustment to account for up to 5% nonadherence.
Methods and design: TRUST trial was developed with PROBE design, as a multicenter, randomized, open label, single-blind clinical trial with the stage of phase 3b.
Study outcomes: The proportion of patients retaining full ability of independent living, which is defined as patients scoring 0-1 on modified Rankin Scale score at 90 days.
Discussion: TRUST trial may potentially provide promising and affordable thrombolysis for acute minor ischemic stroke in the developing parts of the world.