Expired Study
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Glendale, Arizona 85306


Purpose:

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.


Study summary:

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


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 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).


Study is Available At:


Original ID:

22326953211


NCT ID:

NCT00790335


Secondary ID:

U01HL088476-01A1


Study Acronym:

ATTRACT


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

16 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Washington University School of Medicine


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

692


Enrollment Type:

Actual


Overall Contact Information

Official Name:Suresh Vedantham, M.D.
Principal Investigator
Clinical Coordinating Center at Washington University School of Medicine

Study Dates

Start Date:November 2009
Completion Date:January 2017
Completion Type:Actual
Primary Completion Date:January 2017
Primary Completion Type:Actual
Verification Date:February 2018
Last Changed Date:February 28, 2018
First Received Date:October 15, 2008
First Results Date:December 18, 2017

Study Outcomes

Outcome Type:Primary Outcome
Measure:Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale)
Time Frame:Between 6 and 24 months after randomization
Safety Issues:False
Description: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 tre
Outcome Type:Secondary Outcome
Measure:Major Non-post-thrombotic Syndrome Treatment Failure
Time Frame:Through 24 months
Safety Issues:False
Description: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 mon
Outcome Type:Secondary Outcome
Measure:Any Treatment Failure
Time Frame:Through 24 months
Safety Issues:False
Description:Composite of PTS and major non-PTS treatment failure
Outcome Type:Secondary Outcome
Measure:Moderate-to-severe Post-thrombotic Syndrome
Time Frame:Between 6 and 24 months after randomization
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Major Bleeding
Time Frame:Within 10 days after randomization
Safety Issues:False
Description: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).
Outcome Type:Secondary Outcome
Measure:Major Bleeding
Time Frame:Within 24 months after randomization
Safety Issues:False
Description: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).
Outcome Type:Secondary Outcome
Measure:Any (Minor + Major) Bleeding
Time Frame:Within 10 days after randomization
Safety Issues:False
Description:Clinically overt bleeding that occurred through 10 days post-randomization
Outcome Type:Secondary Outcome
Measure:Any (Major + Minor) Bleeding
Time Frame:Within 24 months after randomization
Safety Issues:False
Description:Clinically overt bleeding that occurred within 24 months post-randomization
Outcome Type:Secondary Outcome
Measure:Recurrent Venous Thromboembolism
Time Frame:Within 10 days after randomization
Safety Issues:False
Description:Proportion of patients with symptomatic recurrent venous thromboembolism (including DVT and/or PE)
Outcome Type:Secondary Outcome
Measure:Recurrent Venous Thromboembolism
Time Frame:Within 24 months after randomization
Safety Issues:False
Description:Symptomatic recurrent venous thromboembolism (DVT and/or PE)
Outcome Type:Secondary Outcome
Measure:Death
Time Frame:Within 10 days after randomization
Safety Issues:False
Description:All-cause mortality
Outcome Type:Secondary Outcome
Measure:Death
Time Frame:Within 24 months after randomization
Safety Issues:False
Description:All-cause mortality
Outcome Type:Secondary Outcome
Measure:Severity of Post-thrombotic Syndrome (Villalta)
Time Frame:At 6 months
Safety Issues:False
Description:Mean Villalta scale score at the specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.
Outcome Type:Secondary Outcome
Measure:Severity of Post-thrombotic Syndrome (Villalta)
Time Frame:At 12 months
Safety Issues:False
Description:Mean Villalta scale score at the specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.
Outcome Type:Secondary Outcome
Measure:Severity of Post-thrombotic Syndrome (Villalta)
Time Frame:At 18 months
Safety Issues:False
Description:Mean Villalta scale score at specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.
Outcome Type:Secondary Outcome
Measure:Severity of Post-thrombotic Syndrome (Villalta)
Time Frame:At 24 months
Safety Issues:False
Description:Mean Villalta scale score at specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.
Outcome Type:Secondary Outcome
Measure:Venous Clinical Severity Score
Time Frame:At 6 months
Safety Issues:False
Description:Mean Venous Clinical Severity Score (VCSS) at the specified follow-up visit; range 0-27 (did not use compression item), higher score is worse
Outcome Type:Secondary Outcome
Measure:Venous Clinical Severity Score
Time Frame:At 12 months
Safety Issues:False
Description:Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)
Outcome Type:Secondary Outcome
Measure:Venous Clinical Severity Score
Time Frame:At 18 months
Safety Issues:False
Description:Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)
Outcome Type:Secondary Outcome
Measure:Venous Clinical Severity Score
Time Frame:At 24 months
Safety Issues:False
Description:Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)
Outcome Type:Secondary Outcome
Measure:Change in General Quality of Life - Physical
Time Frame:Baseline to 24 months post-randomization
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Change in General Quality of Life - Mental
Time Frame:Baseline to 24 months post-randomization
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Change in Venous Disease-specific Quality of Life
Time Frame:Baseline to 24 months post-randomization
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Change in Leg Pain Severity
Time Frame:Baseline to 10 days post-randomization
Safety Issues:False
Description:Likert pain scale ranging from 1-7, with higher scores representing a greater intensity of pain
Outcome Type:Secondary Outcome
Measure:Change in Leg Pain Severity
Time Frame:Baseline to 30 days post-randomization
Safety Issues:False
Description:Likert pain scale ranging from 1-7, with higher scores representing a greater intensity of pain
Outcome Type:Secondary Outcome
Measure:Change in Leg Circumference
Time Frame:Baseline to 10 days post-randomization
Safety Issues:False
Description:Mean calf circumference measured 10 cm below the tibial tuberosity
Outcome Type:Secondary Outcome
Measure:Change in Leg Circumference
Time Frame:Baseline to 30 days post-randomization
Safety Issues:False
Description:Mean calf circumference measured 10 cm below the tibial tuberosity

Study Interventions

Intervention Type:Drug
Name:Recombinant tissue plasminogen activator (rt-PA)
Description:Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.
Arm Name:A-Intervention
Other Name:rt-PA

Study Arms

Study Arm Type:Experimental
Arm Name:A-Intervention
Description:PCDT 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 multisidehol
Study Arm Type:No Intervention
Arm Name:B-Control
Description:Initial 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

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Washington University School of Medicine
Agency Class:Other
Agency Type:Collaborator
Agency Name:McMaster University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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. Erratum in: Chest. 2008 Oct;134(4):892.
PMID:18574272
Reference Type:Reference
Citation:Kahn SR. The post-thrombotic syndrome: the forgotten morbidity of deep venous thrombosis. J Thromb Thrombolysis. 2006 Feb;21(1):41-8. Review.
PMID:16475040
Reference Type:Reference
Citation: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.
PMID:16614142
Reference Type:Reference
Citation: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.
PMID:15178716

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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