Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis
Information source: Washington University School of Medicine
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Deep Vein Thrombosis; Venous Thrombosis; Postphlebitic Syndrome; Venous Thromboembolism; Post Thrombotic Syndrome
Intervention: Recombinant tissue plasminogen activator (rt-PA) (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Washington University School of Medicine Official(s) and/or principal investigator(s):
Suresh Vedantham, M.D., Principal Investigator, Affiliation: Clinical Coordinating Center at Washington University School of Medicine
Clive Kearon, MB, MRCP, FRCP(C), PhD, Principal Investigator, Affiliation: Data Coordinating Center at McMaster University-Ontario Clinical Oncology Group
Samuel Z Goldhaber, M.D., Study Chair, Affiliation: Brigham and Women's Hospital
Overall contact:
Patty M Nieters, RN, BSN, Phone: 314 362 3371, Email: nietersp@mir.wustl.edu
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 Details
Official title: Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis--The ATTRACT Trial
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Cumulative incidence of Post-Thrombotic Syndrome (Villalta Scale)
Secondary outcome: 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.Major bleeding, symptomatic pulmonary embolism, recurrent venous thromboembolism, and death
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
Eligibility
Minimum age: 16 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Symptomatic proximal DVT involving the iliac, common femoral, and/or femoral vein.
Exclusion Criteria:
- Age less than 16 years or greater than 70 years.
- Symptom duration > 14 days for the current DVT episode (i. e. subacute or chronic
DVT).
- Established PTS in the ipsilateral leg, previous symptomatic DVT episode in the
ipsilateral leg within the last 2 years, or recent (< 1 month) symptomatic DVT in the
contralateral leg.
- Presence of IVC filter with associated thrombus (acute or chronic), or DVT known to
extend > 3 cm into the IVC (if a filter is present, the IVC should be imaged prior to
randomization).
- Limb-threatening circulatory compromise (i. e., phlegmasia cerulea dolens).
- 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).
- Severe hypertension on repeated readings (systolic > 180 mmHg or diastolic > 105
mmHg).
- Pregnant (positive pregnancy test, women of childbearing age must be tested).
- Recently (< 1 mo) had thrombolysis or is participating in another investigational
drug study.
- Use of clopidogrel, ticlopidine, or other thienopyridine antiplatelet drug in the
last 7 days.
- Life expectancy < 2 years or chronic non-ambulatory status.
- Inability to comply with study assessments (e. g. due to geographic distance).
Locations and Contacts
Patty M Nieters, RN, BSN, Phone: 314 362 3371, Email: nietersp@mir.wustl.edu
St. Joseph Hospital, Orange, California 92868, United States
Stanford University Medical Center, Stanford, California 94305, United States
UCLA-Ronald Reagan Medical Center, Los Angeles, California 90095, United States
Tri-City Medical Center, Oceanside, California 92056, United States
Christiana Care Health Systems, Newark, Delaware 19718, United States
Georgetown University Hospital, Washington, District of Columbia 20007, United States
Baptist Cardiac & Vascular Institute, Miami, Florida 33176, United States
Southern Illinois University, Springfield, Illinois 62702, United States
Central DuPage Hospital, Winfield, Illinois 60190, United States
Maine Medical Center, Portland, Maine 04102, United States
University of Maryland, Baltimore, Maryland 21201, United States
Brigham and Women's Hospital, Boston, Massachusetts 02115, United States
Massachesetts General Hospital, Boston, Massachusetts 02114, United States
University of Michigan Medical Center, Ann Arbor, Michigan 48109, United States
Ann Arbor Veteran's Administration Health System, Ann Arbor, Michigan 48105, United States
Mayo Clinic, Rochester, Minnesota 55905, United States
University of Minnesota, Minneapolis, Minnesota 55455, United States
River Oaks Hospital, Flowood, Mississippi 39232, United States
Washington University School of Medicine, St. Louis, Missouri 63110, United States
Holy Name Hospital, Teaneck, New Jersey 07666, United States
Mount Sinai Medical Center, New York City, New York 10029, United States
New York University Langone Medical Center, New York, New York 10016, United States
Stony Brook University Medical Center, Stony Brook, New York 11794, United States
University of Rochester Medical Center, Rochester, New York 14627, United States
Albany Medical Center, Albany, New York 12208, United States
Wake Forest University Baptist Medical Center, Winston Salem, North Carolina 27157, United States
Forsyth Medical Center, Winston-Salem, North Carolina 27103, United States
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599-7035, United States
Cleveland Clinic, Cleveland, Ohio 44195, United States
Jobst Vascular Center, Toledo, Ohio 43606, United States
Albert Einstein Medical Center, Philadelphia, Pennsylvania 19141, United States
The Reading Hospital and Medical Center, West Reading, Pennsylvania 19611, United States
University of Pittsburgh Medical Center Presbyterian Shadyside, Pittsburgh, Pennsylvania 15213, United States
Rhode Island Hospital, Providence, Rhode Island 02903, United States
The University of Texas Health Science Center at Houston, Houston, Texas 77030, United States
The Methodist Hospital, Houston, Texas 77030, United States
Utah Valley Regional Medical Center, Provo, Utah 84604, United States
University of Virginia Health System, Charlottesville, Virginia 22908, United States
Sacred Heart Medical Center, Spokane, Washington 99204, United States
Medical College of Wisconsin/Froedtert Hospital, Milwaukee, Wisconsin 53226, United States
Additional Information
The Long-Term Clinical Course of Acute Deep Vein Thrombosis Predictors of the Post Thrombotic Syndrome During Long-Term Treatment of Proximal Deep Vein Thrombosis Deep Vein Thrombosis Below-Knee Elastic Compression Stockings to Prevent the Post Thrombotic Syndrome
Related publications: Kearon C, Kahn SR, Agnelli G, Goldhaber S, Raskob GE, Comerota AJ; American College of Chest Physicians. Antithrombotic therapy for venous thromboembolic disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):454S-545S. Erratum in: Chest. 2008 Oct;134(4):892. Kahn SR. The post-thrombotic syndrome: the forgotten morbidity of deep venous thrombosis. J Thromb Thrombolysis. 2006 Feb;21(1):41-8. Review. Vedantham S, Millward SF, Cardella JF, Hofmann LV, Razavi MK, Grassi CJ, Sacks D, Kinney TB; Society of Interventional Radiology. Society of Interventional Radiology position statement: treatment of acute iliofemoral deep vein thrombosis with use of adjunctive catheter-directed intrathrombus thrombolysis. J Vasc Interv Radiol. 2006 Apr;17(4):613-6. No abstract available. Vedantham S, Vesely TM, Sicard GA, Brown D, Rubin B, Sanchez LA, Parti N, Picus D. Pharmacomechanical thrombolysis and early stent placement for iliofemoral deep vein thrombosis. J Vasc Interv Radiol. 2004 Jun;15(6):565-74.
Starting date: November 2009
Ending date: December 2014
Last updated: October 19, 2009
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