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

Abstract

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.