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Sponsors and Collaborators: |
Washington University School of Medicine National Heart, Lung, and Blood Institute (NHLBI) Genentech Bacchus Vascular Possis Medical BSN-JOBST Inc. |
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Information provided by: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00790335 |
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 |
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Deep Vein Thrombosis Venous Thrombosis Postphlebitic Syndrome Venous Thromboembolism Post Thrombotic Syndrome |
Drug: Recombinant tissue plasminogen activator (rt-PA) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis--The ATTRACT Trial |
Estimated Enrollment: | 692 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | January 2014 |
Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A-Intervention: Experimental
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
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Drug: Recombinant tissue plasminogen activator (rt-PA)
Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.
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B-Control: No Intervention
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
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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:
Ages Eligible for Study: | 16 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Patty M Nieters, RN, BSN | 314 362 3371 | nietersp@mir.wustl.edu |
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, Illinois | |
Southern Illinois University | |
Springfield, Illinois, United States, 62702 | |
United States, Michigan | |
University of Michigan Medical Center | |
Ann Arbor, Michigan, United States, 48109 | |
Ann Arbor Veteran's Administration Health System | |
Ann Arbor, Michigan, United States, 48105 | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 | |
United States, Missouri | |
Washington University School of Medicine | |
St. Louis, Missouri, United States, 63110 | |
United States, New Jersey | |
Holy Name Hospital | |
Teaneck, New Jersey, United States, 07666 | |
United States, New York | |
Mount Sinai Medical Center | |
New York City, New York, United States, 10029 | |
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44195 | |
Jobst Vascular Center | |
Toledo, Ohio, United States, 43606 | |
United States, Rhode Island | |
Rhode Island Hospital | |
Providence, Rhode Island, United States, 02903 | |
United States, South Carolina | |
Greenville Hospital System | |
Greenville, South Carolina, United States, 29615 | |
United States, Utah | |
Utah Valley Regional Medical Center | |
Provo, Utah, United States, 84604 | |
United States, Virginia | |
University of Virginia | |
Charlottesville, Virginia, United States, 22908 | |
United States, Washington | |
Sacred Heart Medical Center | |
Spokane, Washington, United States, 99204 |
Principal Investigator: | Suresh Vedantham, MD | Washington University School of Medicine |
Study Chair: | Samuel Z Goldhaber, MD | Brigham and Women's Hospital |
Responsible Party: | Washington University School of Medicine ( Suresh Vedantham, M.D. ) |
Study ID Numbers: | 22326953211, U01 HL088476-01A1 |
Study First Received: | October 15, 2008 |
Last Updated: | November 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00790335 |
Health Authority: | United States: Food and Drug Administration |
deep vein thrombosis deep venous thrombosis post thrombotic syndrome blood clot thrombolysis tissue plasminogen activator |
rt-PA Activase mechanical thrombectomy pharmacomechanical ATTRACT |
Peripheral Vascular Diseases Vascular Diseases Tissue Plasminogen Activator Postthrombotic Syndrome Venous Thromboembolism Thrombosis Thromboembolism |
Embolism and Thrombosis Embolism Venous Insufficiency Phlebitis Venous Thrombosis Plasminogen Postphlebitic Syndrome |
Fibrin Modulating Agents Pathologic Processes Disease Molecular Mechanisms of Pharmacological Action Therapeutic Uses Syndrome |
Hematologic Agents Fibrinolytic Agents Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |