Tenecteplase Pulmonary Embolism Italian Study

Phase 2 Terminated 180 enrolled University Of Perugia

RandomizedParallel-groupQuadruple-blindTreatment

Summary

To assess the efficacy and safety of Tenecteplase versus Placebo in normotensive patients with sub-massive Pulmonary Embolism and Right Ventricular Dysfunction (RVD) all receiving unfractionated heparin (UFH)

Timeline

Start: 2004-07
Primary completion: —
Completion: 2006-07

Outcome

Met primary endpoint

Stopped: “competitor study about to start”

paper 0.31+/-0.08 in patients randomized to tenecteplase as compared to 0.10+/-0.07 in patients randomized to placebo (p=0.04). PMID 19833379 ↗

Publications

Becattini C, Agnelli G, Salvi A, Grifoni S, Pancaldi LG, Enea I, Balsemin F, Campanini M, Ghirarduzzi A, Casazza F; TIPES Study Group. Bolus tenecteplase for right ventricle dysfunction in hemodynamically stable patients with pulmonary embolism. Thromb Res. 2010 Mar;125(3):e82-6. doi: 10.1016/j.thromres.2009.09.017. Epub 2009 Oct 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tenecteplase	Protein / enzyme biologic	—	Intravenous