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Rationale and design of a Phase 3b, Prospective, Randomized, Open Label, Blinded-endpoint, Multicenter Trial of the Efficacy and Safety of Urokinase Thrombolysis Comparing With Antiplatelet Agents for Patients With Minor Stroke
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
Affiliation  

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.

更新日期:2021-04-20
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