Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Newark, Delaware 19718


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


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).



Primary Contact:

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

Backup Contact:


Location Contact:

Newark, Delaware 19718
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.