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

This study is ongoing, but not recruiting participants.
McMaster University
Ontario Clinical Oncology Group (OCOG)
National Heart, Lung, and Blood Institute (NHLBI)
BSN Medical Inc
Genentech, Inc.
Medtronic - MITG
Boston Scientific Corporation
Mid America Heart Institute
Society of Interventional Radiology Foundation
Massachusetts General Hospital
Information provided by (Responsible Party):
Washington University School of Medicine Identifier:
First received: October 15, 2008
Last updated: October 1, 2015
Last verified: October 2015

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.

Condition Intervention Phase
Deep Vein Thrombosis
Venous Thrombosis
Postphlebitic Syndrome
Venous Thromboembolism
Post Thrombotic Syndrome
Drug: Recombinant tissue plasminogen activator (rt-PA)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis--The ATTRACT Trial

Resource links provided by NLM:

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Cumulative incidence of Post-Thrombotic Syndrome (Villalta Scale) [ Time Frame: within 24 months after randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Severity of post thrombotic syndrome, resolution of presenting DVT symptoms, the prevalence of valvular reflux and residual thrombus, the degree of clot lysis, and cost-effectiveness. [ Time Frame: within 24 months of randomization ] [ Designated as safety issue: No ]
  • Major bleeding, symptomatic pulmonary embolism, recurrent venous thromboembolism, and death [ Time Frame: within 10 days and 24 months after randomization ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 692
Study Start Date: November 2009
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A-Intervention
PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm
Drug: Recombinant tissue plasminogen activator (rt-PA)
Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.
Other Names:
  • rt-PA
  • recombinant tissue plasminogen activator
  • Activase
  • Alteplase
No Intervention: B-Control
Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed

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

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Symptomatic proximal DVT involving the iliac, common femoral, and/or femoral vein.

Exclusion Criteria:

  • Age less than 16 years or greater than 75 years.
  • Symptom duration > 14 days for the DVT episode in the index leg (i.e., non-acute DVT).
  • In the index leg: established PTS, or previous symptomatic DVT within the last 2 years.
  • In the contralateral (non-index) leg: symptomatic acute DVT a) involving the iliac and/or common femoral vein; or b) for which thrombolysis is planned as part of the initial therapy.
  • Limb-threatening circulatory compromise.
  • PE with hemodynamic compromise (i.e., hypotension).
  • Inability to tolerate PCDT procedure due to severe dyspnea or acute systemic illness.
  • Allergy, hypersensitivity, or thrombocytopenia from heparin, rt-PA, or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used.
  • Hemoglobin < 9.0 mg/dl, INR > 1.6 before warfarin was started, or platelets < 100,000/ml.
  • Moderate renal impairment in diabetic patients (estimated GFR < 60 ml/min) or severe renal impairment in non-diabetic patients (estimated GFR < 30 ml/min).
  • Active bleeding, recent (< 3 mo) GI bleeding, severe liver dysfunction, bleeding diathesis.
  • Recent (< 3 mo) internal eye surgery or hemorrhagic retinopathy; recent (< 10 days) major surgery, cataract surgery, trauma, CPR, obstetrical delivery, or other invasive procedure.
  • History of stroke or intracranial/intraspinal bleed, tumor, vascular malformation, aneurysm.
  • Active cancer (metastatic, progressive, or treated within the last 6 months). Exception: patients with non-melanoma primary skin cancers are eligible to participate in the study.
  • Severe hypertension on repeated readings (systolic > 180 mmHg or diastolic > 105 mmHg).
  • Pregnant (positive pregnancy test, women of childbearing potential must be tested).
  • Recently (< 1 mo) had thrombolysis or is participating in another investigational drug study.
  • Use of a thienopyridine antiplatelet drug (except clopidogrel) in the last 5 days.
  • Life expectancy < 2 years or chronic non-ambulatory status.
  • Inability to provide informed consent or to comply with study assessments (e.g. due to cognitive impairment or geographic distance).
  Contacts and Locations
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Please refer to this study by its identifier: NCT00790335

  Hide Study Locations
United States, Arizona
Arrowhead Hospital/Phoenix Heart, PLLC
Glendale, Arizona, United States, 85306
United States, California
St. Joseph Hospital
Orange, California, United States, 92868
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Connecticut
Danbury Hospital
Danbury, Connecticut, United States, 06810
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States, 06360
United States, Delaware
Christiana Care Health Systems
Newark, Delaware, United States, 19718
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20007
United States, Florida
Mease Countryside Hospital
Clearwater, Florida, United States, 33761
Baptist Cardiac & Vascular Institute
Miami, Florida, United States, 33176
Florida Hospital
Orlando, Florida, United States, 32803
Florida Hospital-Tampa Division-Pepin Heart Institute and Dr. Kiran C. Patel Research Institute
Tampa, Florida, United States, 33613
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Adventist Midwest Health
Hinsdale, Illinois, United States
Southern Illinois University
Springfield, Illinois, United States, 62702
Central DuPage Hospital
Winfield, Illinois, United States, 60190
United States, Indiana
Indianapolis, Indiana, United States, 46260
United States, Iowa
University of Iowa Carver's College of Medicine
Iowa City, Iowa, United States, 52242
United States, Kentucky
St. Elizabeth Healthcare of Northern Kentucky
Florence, Kentucky, United States, 41042
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Ann Arbor Veteran's Administration Health System
Ann Arbor, Michigan, United States, 48105
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
St. Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, Nebraska
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, United States, 68510-2494
United States, New Jersey
Holy Name Hospital
Teaneck, New Jersey, United States, 07666
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, New York
Cornell Weill Medical Center
New York, New York, United States, 10021
Staten Island University Hospital
Staten Island, New York, United States, 10305
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7035
Wake Forest University Baptist Medical Center
Winston Salem, North Carolina, United States, 27157
Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Good Samaritan Hospital
Cincinatti, Ohio, United States, 45220
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Jobst Vascular Center
Toledo, Ohio, United States, 43606
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
St. Luke's Hospital and Health Network
Bethlehem, Pennsylvania, United States, 18015
Temple University Hospital
Philadelphia, Pennsylvania, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
The Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
University of Pittsburgh Medical Center Presbyterian Shadyside
Pittsburgh, Pennsylvania, United States, 15213
The Reading Hospital and Medical Center
West Reading, Pennsylvania, United States, 19611
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
United States, Utah
Utah Valley Regional Medical Center
Provo, Utah, United States, 84604
University of Utah
Salt Lake City, Utah, United States, 84132
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
United States, Washington
Sacred Heart Medical Center
Spokane, Washington, United States, 99204
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Gundersen Clinic, Ltd.
La Crosse, Wisconsin, United States, 54601
Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Washington University School of Medicine
McMaster University
Ontario Clinical Oncology Group (OCOG)
National Heart, Lung, and Blood Institute (NHLBI)
BSN Medical Inc
Genentech, Inc.
Medtronic - MITG
Boston Scientific Corporation
Mid America Heart Institute
Society of Interventional Radiology Foundation
Massachusetts General Hospital
Principal Investigator: Suresh Vedantham, M.D. Clinical Coordinating Center at Washington University School of Medicine
Principal Investigator: Clive Kearon, MB, MRCP, FRCP(C), PhD Data Coordinating Center at McMaster University-Ontario Clinical Oncology Group
Study Chair: Samuel Z Goldhaber, M.D. Brigham and Women's Hospital
  More Information

Additional Information:
Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Washington University School of Medicine Identifier: NCT00790335     History of Changes
Other Study ID Numbers: 22326953211, U01 HL088476-01A1
Study First Received: October 15, 2008
Last Updated: October 1, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:
deep vein thrombosis
deep venous thrombosis
post thrombotic syndrome
blood clot
tissue plasminogen activator
mechanical thrombectomy

Additional relevant MeSH terms:
Postphlebitic Syndrome
Postthrombotic Syndrome
Venous Thromboembolism
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Pathologic Processes
Peripheral Vascular Diseases
Vascular Diseases
Venous Insufficiency
Tissue Plasminogen Activator
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on October 06, 2015