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.