NCT00790335

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 692 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

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

Interventions

Type	Name	Description
DRUG	Recombinant tissue plasminogen activator (rt-PA)	Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Timeline

• Start date: 2009-11-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2008-11-13
• Last updated: 2018-03-29
• Results posted: 2018-03-29

Locations

56 sites across 1 country: United States