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Clinical Trial Summary

The purpose of this study is to determine if the use of adjunctive Pharmacomechanical Catheter Directed Thrombolysis, which includes the intrathrombus administration of rt-PA--Activase (Alteplase),can prevent the post-thrombotic syndrome(PTS)in patients with symptomatic proximal deep vein thrombosis(DVT)as compared with optimal standard DVT therapy alone.


Clinical Trial Description

Activase, the study drug, is a fibrinolytic drug that is indicated for use in acute myocardial infarction, acute ischemic stroke, and acute massive pulmonary embolism in adults. Previous studies have established the ability of rt-PA to lyse venous thrombus in patients with deep vein thrombosis (DVT), and suggest that successful rt-PA mediated thrombolysis can prevent the post-thrombotic syndrome (PTS), a morbid, late complication of DVT that occurs in nearly 50% of patients.

rt-PA is delivered directly into venous thrombus using a catheter/device which is embedded within the thrombus by a physician under imaging guidance. This method of rt-PA delivery, pharmacomechanical catheter-directed intrathrombus thrombolysis (PCDT),is thought to be safer, more effective, and more efficient than previous methods. The question of whether PCDT using rt-PA improves long-term DVT patient outcomes with acceptable risk and cost has not yet been addressed.

The rationale for performing the ATTRACT Trial is based upon:

- the major burden of PTS on DVT patients and the U.S. healthcare system

- the association between rapid clot lysis and prevention of PTS

- the proven ability of rt-PA to dissolve venous thrombus in proximal DVT

- recent advances in CDT methods which may lower bleeding risk

- the major clinical controversy on whether CDT should be routinely used for first-line DVT therapy ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00790335
Study type Interventional
Source Washington University School of Medicine
Contact
Status Completed
Phase Phase 3
Start date November 2009
Completion date January 2017

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