Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis
This trial is active, not recruiting.
|Conditions||deep vein thrombosis, venous thrombosis, postphlebitic syndrome, venous thromboembolism, post thrombotic syndrome|
|Treatment||recombinant tissue plasminogen activator (rt-pa)|
|Sponsor||Washington University School of Medicine|
|Start date||November 2009|
|End date||January 2017|
|Trial size||692 participants|
|Trial identifier||NCT00790335, 22326953211, U01HL088476-01A1|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Glendale, AZ||Arrowhead Hospital/Phoenix Heart, PLLC||no longer recruiting|
|Orange, CA||St. Joseph Hospital||no longer recruiting|
|Stanford, CA||Stanford University Medical Center||no longer recruiting|
|Danbury, CT||Danbury Hospital||no longer recruiting|
|Norwich, CT||Eastern Connecticut Hematology and Oncology Associates||no longer recruiting|
|Newark, DE||Christiana Care Health Systems||no longer recruiting|
|Washington, DC||Georgetown University Hospital||no longer recruiting|
|Clearwater, FL||Mease Countryside Hospital||no longer recruiting|
|Miami, FL||Baptist Cardiac & Vascular Institute||no longer recruiting|
|Orlando, FL||Florida Hospital||no longer recruiting|
|Tampa, FL||Florida Hospital-Tampa Division-Pepin Heart Institute and Dr. Kiran C. Patel Research Institute||no longer recruiting|
|Chicago, IL||University of Illinois at Chicago||no longer recruiting|
|Hinsdale, IL||Adventist Midwest Health||no longer recruiting|
|Springfield, IL||Southern Illinois University||no longer recruiting|
|Winfield, IL||Central DuPage Hospital||no longer recruiting|
|Indianapolis, IN||CorVasc||no longer recruiting|
|Iowa City, IA||University of Iowa Carver's College of Medicine||no longer recruiting|
|Florence, KY||St. Elizabeth Healthcare of Northern Kentucky||no longer recruiting|
|Portland, ME||Maine Medical Center||no longer recruiting|
|Baltimore, MD||University of Maryland||no longer recruiting|
|Boston, MA||Massachusetts General Hospital||no longer recruiting|
|Ann Arbor, MI||Ann Arbor Veteran's Administration Health System||no longer recruiting|
|Ann Arbor, MI||University of Michigan Medical Center||no longer recruiting|
|Detroit, MI||Henry Ford Health System||no longer recruiting|
|Minneapolis, MN||University of Minnesota||no longer recruiting|
|Rochester, MN||Mayo Clinic||no longer recruiting|
|Kansas City, MO||St. Luke's Hospital of Kansas City||no longer recruiting|
|St. Louis, MO||Washington University School of Medicine||no longer recruiting|
|Lincoln, NE||Saint Elizabeth Regional Medical Center||no longer recruiting|
|Teaneck, NJ||Holy Name Hospital||no longer recruiting|
|Albuquerque, NM||University of New Mexico||no longer recruiting|
|New York, NY||Cornell Weill Medical Center||no longer recruiting|
|Staten Island, NY||Staten Island University Hospital||no longer recruiting|
|Chapel Hill, NC||University of North Carolina at Chapel Hill||no longer recruiting|
|Winston Salem, NC||Wake Forest University Baptist Medical Center||no longer recruiting|
|Winston-Salem, NC||Forsyth Medical Center||no longer recruiting|
|Cincinatti, OH||Good Samaritan Hospital||no longer recruiting|
|Cleveland, OH||Cleveland Clinic||no longer recruiting|
|Columbus, OH||Riverside Methodist Hospital||no longer recruiting|
|Toledo, OH||Jobst Vascular Center||no longer recruiting|
|Portland, OR||Oregon Health & Science University||no longer recruiting|
|Bethlehem, PA||St. Luke's Hospital and Health Network||no longer recruiting|
|Philadelphia, PA||Albert Einstein Medical Center||no longer recruiting|
|Philadelphia, PA||Temple University Hospital||no longer recruiting|
|Pittsburgh, PA||Allegheny General Hospital||no longer recruiting|
|Pittsburgh, PA||University of Pittsburgh Medical Center Presbyterian Shadyside||no longer recruiting|
|Pittsburgh, PA||The Western Pennsylvania Hospital||no longer recruiting|
|West Reading, PA||The Reading Hospital and Medical Center||no longer recruiting|
|Providence, RI||Rhode Island Hospital||no longer recruiting|
|Charleston, SC||Medical University of South Carolina||no longer recruiting|
|Dallas, TX||University of Texas Southwestern Medical Center||no longer recruiting|
|Provo, UT||Utah Valley Regional Medical Center||no longer recruiting|
|Salt Lake City, UT||University of Utah||no longer recruiting|
|Charlottesville, VA||University of Virginia Health System||no longer recruiting|
|Spokane, WA||Sacred Heart Medical Center||no longer recruiting|
|Morgantown, WV||West Virginia University||no longer recruiting|
|La Crosse, WI||Gundersen Clinic, Ltd.||no longer recruiting|
|Milwaukee, WI||Medical College of Wisconsin/Froedtert Hospital||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Cumulative incidence of Post-Thrombotic Syndrome (Villalta Scale)
time frame: within 24 months after randomization
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
Major bleeding, symptomatic pulmonary embolism, recurrent venous thromboembolism, and death
time frame: within 10 days and 24 months after randomization
Male or female participants from 16 years up to 75 years old.
- Symptomatic proximal DVT involving the iliac, common femoral, and/or femoral vein.
- 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).
|Official title||Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis--The ATTRACT Trial|
|Principal investigator||Suresh Vedantham, M.D.|
|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|
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