Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke (DIAS-4)

Phase 3 Terminated 270 enrolled H. Lundbeck A/S

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of the study is to determine whether desmoteplase is effective and safe in the treatment of patients with acute ischaemic stroke when given within 3 to 9 hours from onset of stroke symptoms.

Timeline

Start: 2009-04
Primary completion: 2014-10
Completion: —

Outcome

Missed primary endpoint

Stopped (Enrollment): “The recruitment into DIAS4 has been stopped as the result of DIAS 3 indicates that the study is unlikely to reach its primary endpoint with the current protocol”

registry analysis (superiority or other test); Desmoteplase vs Placebo; p = 0.2290; Odds Ratio (OR) 1.45 (95% CI 0.79 to 2.64); Regression, Logistic NCT00856661 ↗

Publications

von Kummer R, Mori E, Truelsen T, Jensen JS, Gronning BA, Fiebach JB, Lovblad KO, Pedraza S, Romero JM, Chabriat H, Chang KC, Davalos A, Ford GA, Grotta J, Kaste M, Schwamm LH, Shuaib A, Albers GW; DIAS-4 Investigators. Desmoteplase 3 to 9 Hours After Major Artery Occlusion Stroke: The DIAS-4 Trial (Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke). Stroke. 2016 Dec;47(12):2880-2887. doi: 10.1161/STROKEAHA.116.013715. Epub 2016 Nov 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Desmoteplase	Protein / enzyme biologic	90 ug/kg	Intravenous