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

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

ClinicalTrials.gov Link:

https://clinicaltrials.gov/show/NCT00790335

Overall Status:

Completed

Study Phase:

Phase 3

Genders:

N/A

Minimum Age:

16 Years

Maximum Age:

75 Years

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

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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