Document Detail


Rationale and design of the ATTRACT Study: a multicenter randomized trial to evaluate pharmacomechanical catheter-directed thrombolysis for the prevention of postthrombotic syndrome in patients with proximal deep vein thrombosis.
MedLine Citation:
PMID:  23537968     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Current standard therapy for patients with acute proximal deep vein thrombosis (DVT) consists of anticoagulant therapy and graduated elastic compression stockings. Despite use of this strategy, the postthrombotic syndrome (PTS) develops frequently, causes substantial patient disability, and impairs quality of life. Pharmacomechanical catheter-directed thrombolysis (PCDT), which rapidly removes acute venous thrombus, may reduce the frequency of PTS. However, this hypothesis has not been tested in a large multicenter randomized trial.
STUDY DESIGN: The ATTRACT Study is an ongoing National Institutes of Health-sponsored, Phase III, multicenter, randomized, open-label, assessor-blinded, parallel two-arm, controlled clinical trial. Approximately 692 patients with acute proximal DVT involving the femoral, common femoral, and/or iliac vein are being randomized to receive PCDT + standard therapy versus standard therapy alone. The primary study hypothesis is that PCDT will reduce the proportion of patients who develop PTS within 2 years by one-third, assessed using the Villalta Scale. Secondary outcomes include safety, general and venous disease-specific quality of life, relief of early pain and swelling, and cost-effectiveness.
CONCLUSION: ATTRACT will determine if PCDT should be routinely used to prevent PTS in patients with symptomatic proximal DVT above the popliteal vein.
Authors:
Suresh Vedantham; Samuel Z Goldhaber; Susan R Kahn; Jim Julian; Elizabeth Magnuson; Michael R Jaff; Timothy P Murphy; David J Cohen; Anthony J Comerota; Heather L Gornik; Mahmood K Razavi; Lawrence Lewis; Clive Kearon
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Publication Detail:
Type:  Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't     Date:  2013-03-05
Journal Detail:
Title:  American heart journal     Volume:  165     ISSN:  1097-6744     ISO Abbreviation:  Am. Heart J.     Publication Date:  2013 Apr 
Date Detail:
Created Date:  2013-03-29     Completed Date:  2013-06-24     Revised Date:  2014-04-02    
Medline Journal Info:
Nlm Unique ID:  0370465     Medline TA:  Am Heart J     Country:  United States    
Other Details:
Languages:  eng     Pagination:  523-530.e3     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2013 Mosby, Inc. All rights reserved.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00790335
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MeSH Terms
Descriptor/Qualifier:
Anticoagulants / therapeutic use
Clinical Trials, Phase III as Topic
Cost-Benefit Analysis
Heparin / therapeutic use
Humans
Intention to Treat Analysis
Postthrombotic Syndrome / prevention & control*
Quality of Life
Randomized Controlled Trials as Topic
Research Design
Thrombolytic Therapy / economics,  methods*
Grant Support
ID/Acronym/Agency:
U01 HL088118/HL/NHLBI NIH HHS; U01 HL088476/HL/NHLBI NIH HHS; U01-HL088118/HL/NHLBI NIH HHS; U01-HL088476/HL/NHLBI NIH HHS
Chemical
Reg. No./Substance:
0/Anticoagulants; 9005-49-6/Heparin
Comments/Corrections

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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