Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis — ATTRACT  

Venous Thromboembolism Clinical Trial

Official title: Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis--The ATTRACT Trial

Status Completed

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 ;

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Post Thrombotic Syndrome
• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Syndrome
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

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