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Deep Vein ThrombosisPhase 3ATTRACTNCT00790335

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

A Phase 3 study testing Recombinant tissue plasminogen activator (rt-PA) in people with Deep Vein Thrombosis and Venous Thrombosis, run by Washington University School of Medicine at 56 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 16 to 75 years
What is being tested?
Recombinant tissue plasminogen activator (rt-PA)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
692 participants
Where
56 sitesUnited States
Study dates
Nov 2009to Jan 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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).
Show all 20Show fewer
  • 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).

Trial locations and contacts

56 sites in 1 country.

56 sites in 1 country

United States56 sites

  • University of New Mexico

    Albuquerque, New Mexico, 87131

  • Ann Arbor Veteran's Administration Health System

    Ann Arbor, Michigan, 48105

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48109

  • University of Maryland

    Baltimore, Maryland, 21201

  • St. Luke's Hospital and Health Network

    Bethlehem, Pennsylvania, 18015

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599-7035

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

  • Good Samaritan Hospital

    Cincinnati, Ohio, 45220

  • Mease Countryside Hospital

    Clearwater, Florida, 33761

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Danbury Hospital

    Danbury, Connecticut, 06810

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • St. Elizabeth Healthcare of Northern Kentucky

    Florence, Kentucky, 41042

  • Arrowhead Hospital/Phoenix Heart, PLLC

    Glendale, Arizona, 85306

  • Adventist Midwest Health

    Hinsdale, Illinois

  • CorVasc

    Indianapolis, Indiana, 46260

  • University of Iowa Carver's College of Medicine

    Iowa City, Iowa, 52242

  • St. Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Gundersen Clinic, Ltd.

    La Crosse, Wisconsin, 54601

  • Saint Elizabeth Regional Medical Center

    Lincoln, Nebraska, 68510-2494

  • Baptist Cardiac & Vascular Institute

    Miami, Florida, 33176

  • Medical College of Wisconsin/Froedtert Hospital

    Milwaukee, Wisconsin, 53226

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Cornell Weill Medical Center

    New York, New York, 10021

  • Christiana Care Health Systems

    Newark, Delaware, 19718

  • Eastern Connecticut Hematology and Oncology Associates

    Norwich, Connecticut, 06360

  • St. Joseph Hospital

    Orange, California, 92868

  • Florida Hospital

    Orlando, Florida, 32803

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • Temple University Hospital

    Philadelphia, Pennsylvania

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • University of Pittsburgh Medical Center Presbyterian Shadyside

    Pittsburgh, Pennsylvania, 15213

  • The Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • Maine Medical Center

    Portland, Maine, 04102

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Utah Valley Regional Medical Center

    Provo, Utah, 84604

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Utah

    Salt Lake City, Utah, 84132

  • Sacred Heart Medical Center

    Spokane, Washington, 99204

  • Southern Illinois University

    Springfield, Illinois, 62702

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stanford University Medical Center

    Stanford, California, 94305

  • Staten Island University Hospital

    Staten Island, New York, 10305

  • Florida Hospital-Tampa Division-Pepin Heart Institute and Dr. Kiran C. Patel Research Institute

    Tampa, Florida, 33613

  • Holy Name Hospital

    Teaneck, New Jersey, 07666

  • Jobst Vascular Center

    Toledo, Ohio, 43606

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • The Reading Hospital and Medical Center

    West Reading, Pennsylvania, 19611

  • Central DuPage Hospital

    Winfield, Illinois, 60190

  • Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: 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.

Read the 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
Being tested
Recombinant tissue plasminogen activator (rt-PA)
Keywords
deep vein thrombosis, deep venous thrombosis, post thrombotic syndrome, blood clot, thrombolysis, tissue plasminogen activator, rt-PA, Activase, mechanical thrombectomy, pharmacomechanical, ATTRACT
Medical subject headings
Venous Thrombosis, Postphlebitic Syndrome, Venous Thromboembolism, Postthrombotic Syndrome, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recombinant tissue plasminogen activator (rt-PA)Drug

    Also called rt-PA, recombinant tissue plasminogen activator, Activase, Alteplase

    Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.

Study groups in NCT00790335
Study groupRoleWhat they receive
A-InterventionExperimentalPCDT with intrathrombus delivery of recombinant tissue plasminogen activator (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
Receives: Drug: Recombinant tissue plasminogen activator (rt-PA)
B-ControlNo interventionInitial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target international normalized ratio 2.0 - 3.0). Elastic compression stockings will be prescribed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale)

    Patients who experienced one of the following occurrences in the index leg between the 6 month and 24 month post-randomization follow-up visits, inclusive: 1) Villalta score of 5 or greater; 2) leg ulcer; or 3) late endovascular procedure performed to treat severe venous disease. The Villalta scale ranges from 0-33 points, with higher scores being worse.

    Measured: Between 6 and 24 months after randomization

Secondary outcomes (26)

  1. Major Non-post-thrombotic Syndrome Treatment Failure

    A major non-post-thrombotic-syndrome treatment failure refers to when any of three events occurred in the index leg: 1) an unplanned endovascular procedure to treat severe venous symptoms within 6 months post-randomization; 2) venous gangrene within 6 months; or 3) an amputation within 24 months.

    Measured: Through 24 months

  2. Any Treatment Failure

    Composite of PTS and major non-PTS treatment failure

    Measured: Through 24 months

  3. Moderate-to-severe Post-thrombotic Syndrome

    Proportion of patients with Villalta score of 10 or higher at any time between the 6 month and 24 month follow-up visits, inclusive. The Villalta scale ranges from 0-33 points, with higher scores being worse.

    Measured: Between 6 and 24 months after randomization

  4. Major Bleeding

    Defined as clinically overt bleeding that is associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g. intracranial, intraspinal).

    Measured: Within 10 days after randomization

  5. Major Bleeding

    Defined as clinically overt bleeding that was associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g. intracranial, intraspinal).

    Measured: Within 24 months after randomization

  6. Any (Minor + Major) Bleeding

    Clinically overt bleeding that occurred through 10 days post-randomization

    Measured: Within 10 days after randomization

  7. Any (Major + Minor) Bleeding

    Clinically overt bleeding that occurred within 24 months post-randomization

    Measured: Within 24 months after randomization

  8. Recurrent Venous Thromboembolism

    Proportion of patients with symptomatic recurrent venous thromboembolism (including DVT and/or PE)

    Measured: Within 10 days after randomization

  9. Recurrent Venous Thromboembolism

    Symptomatic recurrent venous thromboembolism (DVT and/or PE)

    Measured: Within 24 months after randomization

  10. Death

    All-cause mortality

    Measured: Within 10 days after randomization

  11. Death

    All-cause mortality

    Measured: Within 24 months after randomization

  12. Severity of Post-thrombotic Syndrome (Villalta)

    Mean Villalta scale score at the specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.

    Measured: At 6 months

  13. Severity of Post-thrombotic Syndrome (Villalta)

    Mean Villalta scale score at the specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.

    Measured: At 12 months

  14. Severity of Post-thrombotic Syndrome (Villalta)

    Mean Villalta scale score at specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.

    Measured: At 18 months

  15. Severity of Post-thrombotic Syndrome (Villalta)

    Mean Villalta scale score at specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.

    Measured: At 24 months

  16. Venous Clinical Severity Score

    Mean Venous Clinical Severity Score (VCSS) at the specified follow-up visit; range 0-27 (did not use compression item), higher score is worse

    Measured: At 6 months

  17. Venous Clinical Severity Score

    Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)

    Measured: At 12 months

  18. Venous Clinical Severity Score

    Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)

    Measured: At 18 months

  19. Venous Clinical Severity Score

    Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)

    Measured: At 24 months

  20. Change in General Quality of Life - Physical

    Short-Form-36 Health Survey, Version 2, Physical Component Summary (PCS) Scale. Range of scores 0-100 with higher scores representing better quality of life.

    Measured: Baseline to 24 months post-randomization

  21. Change in General Quality of Life - Mental

    Short-Form-36 Health Survey, Version 2, Mental Component Summary (MCS) Scale. Range of scores 0-100 with higher scores representing better quality of life.

    Measured: Baseline to 24 months post-randomization

  22. Change in Venous Disease-specific Quality of Life

    Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) questionnaire. Range of scores 0-100 with higher scores representing better quality of life, and higher change scores representing greater improvement from baseline.

    Measured: Baseline to 24 months post-randomization

  23. Change in Leg Pain Severity

    Likert pain scale ranging from 1-7, with higher scores representing a greater intensity of pain

    Measured: Baseline to 10 days post-randomization

  24. Change in Leg Pain Severity

    Likert pain scale ranging from 1-7, with higher scores representing a greater intensity of pain

    Measured: Baseline to 30 days post-randomization

  25. Change in Leg Circumference

    Mean calf circumference measured 10 cm below the tibial tuberosity

    Measured: Baseline to 10 days post-randomization

  26. Change in Leg Circumference

    Mean calf circumference measured 10 cm below the tibial tuberosity

    Measured: Baseline to 30 days post-randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2008 (estimated)
  2. Study startNov 2009
  3. Primary completionJan 2017
  4. Study completionJan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
692 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00790335
Sponsor's protocol ID
22326953211
Other IDs
U01HL088476-01A1
Acronym
ATTRACT
Status last verified
Feb 2018
First submitted
15 Oct 2008
Last updated
29 Mar 2018
Data monitoring committee
Yes

Publications

  • Kearon C, Kahn SR, Agnelli G, Goldhaber S, Raskob GE, Comerota AJ. 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. doi: 10.1378/chest.08-0658.

    PubMed 18574272

  • Kahn SR. The post-thrombotic syndrome: the forgotten morbidity of deep venous thrombosis. J Thromb Thrombolysis. 2006 Feb;21(1):41-8. doi: 10.1007/s11239-006-5574-9.

    PubMed 16475040

  • 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. doi: 10.1097/01.RVI.0000203802.35689.66. No abstract available.

    PubMed 16614142

  • 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. doi: 10.1097/01.rvi.0000127894.00553.02.

    PubMed 15178716

  • Flumignan RL, Nakano LC, Flumignan CD, Baptista-Silva JC. Angioplasty or stenting for deep venous thrombosis. Cochrane Database Syst Rev. 2025 Feb 19;2(2):CD011468. doi: 10.1002/14651858.CD011468.pub2.

    PubMed 39968829

  • Li W, Kessinger CW, Orii M, Lee H, Wang L, Weinberg I, Jaff MR, Reed GL, Libby P, Tawakol A, Henke PK, Jaffer FA. Time-Restricted Salutary Effects of Blood Flow Restoration on Venous Thrombosis and Vein Wall Injury in Mouse and Human Subjects. Circulation. 2021 Mar 23;143(12):1224-1238. doi: 10.1161/CIRCULATIONAHA.120.049096. Epub 2021 Jan 15.

    PubMed 33445952

  • Kahn SR, Julian JA, Kearon C, Gu CS, Cohen DJ, Magnuson EA, Comerota AJ, Goldhaber SZ, Jaff MR, Razavi MK, Kindzelski AL, Schneider JR, Kim P, Chaer R, Sista AK, McLafferty RB, Kaufman JA, Wible BC, Blinder M, Vedantham S; ATTRACT Trial Investigators. Quality of life after pharmacomechanical catheter-directed thrombolysis for proximal deep venous thrombosis. J Vasc Surg Venous Lymphat Disord. 2020 Jan;8(1):8-23.e18. doi: 10.1016/j.jvsv.2019.03.023.

    PubMed 31843251

  • Magnuson EA, Chinnakondepalli K, Vilain K, Kearon C, Julian JA, Kahn SR, Goldhaber SZ, Jaff MR, Kindzelski AL, Herman K, Brady PS, Sharma K, Black CM, Vedantham S, Cohen DJ. Cost-Effectiveness of Pharmacomechanical Catheter-Directed Thrombolysis Versus Standard Anticoagulation in Patients With Proximal Deep Vein Thrombosis: Results From the ATTRACT Trial. Circ Cardiovasc Qual Outcomes. 2019 Oct;12(10):e005659. doi: 10.1161/CIRCOUTCOMES.119.005659. Epub 2019 Oct 8.

    PubMed 31592728

  • Weinberg I, Vedantham S, Salter A, Hadley G, Al-Hammadi N, Kearon C, Julian JA, Razavi MK, Gornik HL, Goldhaber SZ, Comerota AJ, Kindzelski AL, Schainfeld RM, Angle JF, Misra S, Schor JA, Hurst D, Jaff MR; ATTRACT Trial Investigators. Relationships between the use of pharmacomechanical catheter-directed thrombolysis, sonographic findings, and clinical outcomes in patients with acute proximal DVT: Results from the ATTRACT Multicenter Randomized Trial. Vasc Med. 2019 Oct;24(5):442-451. doi: 10.1177/1358863X19862043. Epub 2019 Jul 27.

    PubMed 31354089

  • Kearon C, Gu CS, Julian JA, Goldhaber SZ, Comerota AJ, Gornik HL, Murphy TP, Lewis L, Kahn SR, Kindzelski AL, Slater D, Geary R, Winokur R, Natarajan K, Dietzek A, Leung DA, Kim S, Vedantham S. Pharmacomechanical Catheter-Directed Thrombolysis in Acute Femoral-Popliteal Deep Vein Thrombosis: Analysis from a Stratified Randomized Trial. Thromb Haemost. 2019 Apr;119(4):633-644. doi: 10.1055/s-0039-1677795. Epub 2019 Jan 30.

    PubMed 30699446

  • Comerota AJ, Kearon C, Gu CS, Julian JA, Goldhaber SZ, Kahn SR, Jaff MR, Razavi MK, Kindzelski AL, Bashir R, Patel P, Sharafuddin M, Sichlau MJ, Saad WE, Assi Z, Hofmann LV, Kennedy M, Vedantham S; ATTRACT Trial Investigators. Endovascular Thrombus Removal for Acute Iliofemoral Deep Vein Thrombosis. Circulation. 2019 Feb 26;139(9):1162-1173. doi: 10.1161/CIRCULATIONAHA.118.037425.

    PubMed 30586751

  • Vedantham S, Goldhaber SZ, Julian JA, Kahn SR, Jaff MR, Cohen DJ, Magnuson E, Razavi MK, Comerota AJ, Gornik HL, Murphy TP, Lewis L, Duncan JR, Nieters P, Derfler MC, Filion M, Gu CS, Kee S, Schneider J, Saad N, Blinder M, Moll S, Sacks D, Lin J, Rundback J, Garcia M, Razdan R, VanderWoude E, Marques V, Kearon C; ATTRACT Trial Investigators. Pharmacomechanical Catheter-Directed Thrombolysis for Deep-Vein Thrombosis. N Engl J Med. 2017 Dec 7;377(23):2240-2252. doi: 10.1056/NEJMoa1615066.

    PubMed 29211671

  • Vedantham S, Goldhaber SZ, Kahn SR, Julian J, Magnuson E, Jaff MR, Murphy TP, Cohen DJ, Comerota AJ, Gornik HL, Razavi MK, Lewis L, Kearon C. Rationale and design of the ATTRACT Study: a multicenter randomized trial to evaluate pharmacomechanical catheter-directed thrombolysis for the prevention of postthrombotic syndrome in patients with proximal deep vein thrombosis. Am Heart J. 2013 Apr;165(4):523-530.e3. doi: 10.1016/j.ahj.2013.01.024. Epub 2013 Mar 5.

    PubMed 23537968

  • Comerota AJ. The ATTRACT trial: rationale for early intervention for iliofemoral DVT. Perspect Vasc Surg Endovasc Ther. 2009 Dec;21(4):221-4; quiz 224-5. doi: 10.1177/1531003509359311. Epub 2010 Jan 3.

    PubMed 20047905

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Recombinant tissue plasminogen activator (rt-PA) in people with Deep Vein Thrombosis and Venous Thrombosis, run by Washington University School of Medicine at 56 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale) (time frame: Between 6 and 24 months after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00790335, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.

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