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



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:16 - 75
Updated:4/17/2018
Start Date:November 2009
End Date:January 2017

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Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis--The ATTRACT Trial

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.

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

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.

- Pulmonary embolism 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 glomerular filtration rate
[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, cardiopulmonary resuscitation, 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).
We found this trial at
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185 Cambridge Street
Boston, Massachusetts 02114
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Chapel Hill, North Carolina 27599
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3231 North McMullen Booth Road
Clearwater, Florida 33761
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
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8900 North Kendall Drive
Miami, Florida 33176
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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22 Bramhall St
Portland, Maine 04102
(207) 662-0111
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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Albuquerque, New Mexico 87131
(505) 277-0111
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Ann Arbor, Michigan 48109
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Baltimore, Maryland 20742
(301) 405-1000
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801 Ostrum St
Bethlehem, Pennsylvania 18015
(484) 526-4000
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
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Cincinnati, Ohio 45220
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3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
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Danbury, Connecticut 06810
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Detroit, Michigan 48202
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Glendale, Arizona 85306
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Indianapolis, Indiana 46260
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Kansas City, Missouri 64111
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La Crosse, Wisconsin 54601
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Lincoln, Nebraska 68510
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New York, New York 10021
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Newark, Delaware 19713
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330 Washington St #220
Norwich, Connecticut 06360
(860) 886-8362
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Orange, California 92868
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Florida Hospital Florida Hospital is one of the country
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5501 Old York Road
Philadelphia, Pennsylvania 19141
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3401 N Broad St
Philadelphia, Pennsylvania
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Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
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Rochester, Minnesota 55905
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
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Spokane, Washington 99204
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327 W Calhoun Ave
Springfield, Illinois 62702
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300 Pasteur Dr
Stanford, California 94305
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475 Seaview Ave
Staten Island, New York 10305
(718) 226-9000
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Teaneck, New Jersey 07666
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Toledo, Ohio 43606
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 444-2000
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West Reading, Pennsylvania 19612
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Winfield, Illinois 60190
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Winston-Salem, North Carolina 27103
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1 Medical Center Blvd
Winston-Salem, North Carolina 27103
(336) 716-2011
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