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View Clinical Trial (Medical Research Study)
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Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis - NCT00790335-53226 (Clinical Trial 344615)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy344615.aspx
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| City: |
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Milwaukee |
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State:
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WI |
| Zip Code: |
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53226 |
| Conditions: |
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Deep Vein Thrombosis - Venous Thrombosis - Postphlebitic Syndrome - Venous Thromboembolism - Post Thrombotic Syndrome |
| Purpose: |
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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.
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| Study summary: |
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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: |
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Inclusion Criteria:
- Symptomatic proximal DVT involving the iliac, common femoral, and/or femoral vein.
Exclusion Criteria:
- Age less than 16 years or greater than 70 years.
- Symptom duration > 14 days for the current DVT episode (i.e. subacute or chronic
DVT).
- Established PTS in the ipsilateral leg, previous symptomatic DVT episode in the
ipsilateral leg within the last 2 years, or recent (< 1 month) symptomatic DVT in the
contralateral leg.
- Presence of IVC filter with associated thrombus (acute or chronic), or DVT known to
extend > 3 cm into the IVC (if a filter is present, the IVC should be imaged prior to
randomization).
- Limb-threatening circulatory compromise (i.e., phlegmasia cerulea dolens).
- PE 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 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, CPR, 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).
- Severe hypertension on repeated readings (systolic > 180 mmHg or diastolic > 105
mmHg).
- Pregnant (positive pregnancy test, women of childbearing age must be tested).
- Recently (< 1 mo) had thrombolysis or is participating in another investigational
drug study.
- Use of clopidogrel, ticlopidine, or other thienopyridine antiplatelet drug in the
last 7 days.
- Life expectancy < 2 years or chronic non-ambulatory status.
- Inability to comply with study assessments (e.g. due to geographic distance). |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 4, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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