Safety and Efficacy of Low Molecular Weight Heparin for 72 Hours Followed by Dabigatran for the Treatment of Acute Intermediate-Risk Pulmonary Embolism
- Conditions
- Acute Pulmonary Embolism (PE)10037454
- Registration Number
- NL-OMON45434
- Lead Sponsor
- niversity Medical Center of the Johannes Gutenberg University of Mainz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Age >=18 years; 2) Objectively confirmed diagnosis of acute PE by multidetector CT angiography, ventilation/perfusion lung scan, or selective invasive pulmonary angiography, according to established diagnostic criteria; 3) Absence of hemodynamic collapse/decompensation at presentation; 4) Intermediate-risk category of PE severity indicated by the presence of at least one of the following a, b, or c criteria: a) At least one sign of RV pressure overload/dysfunction on CT angiography or echocardiography (8,23): a1) on CT angiography, RV pressure overload/dysfunction is defined as RV/LV end-diastolic diameter ratio >1.0; or a2) on echocardiography, RV pressure overload/dysfunction is defined by the presence of at least one of the following findings: RV/LV end*diastolic diameter ratio >1.0 (apical or subcostal 4*chamber view); RV end*diastolic diameter >30 mm (parasternal long*axis or short*axis view); RV free wall hypokinesis (any view); Tricuspid regurgitant jet velocity >2.6 m/s from the apical or subcostal 4*chamber view, or the parasternal short*axis view; Absence of inspiratory collapse of the inferior vena cava. b) Signs of myocardial injury as indicated by elevated troponin levels: Troponin elevation is defined as an abnormal result of any validated troponin test based on the reference values determined by the local Department of Clinical Chemistry at each participating site; c) Signs of (RV) failure as indicated by NT-proBNP levels >600 pg/ml 5) Signed and dated informed consent of the subject available.
Pregnancy or women of childbearing potential who do not practice a medically accepted highly effective contraception during the trial; 2) Use of a fibrinolytic agent, surgical thrombectomy, interventional (catheter-directed) thrombus aspiration or lysis, or use of a cava filter to treat the index episode of PE; 3) Need for long-term treatment with a low molecular weight heparin, a vitamin K antagonists, or a new oral anticoagulant (rivaroxaban, dabigatran, apixaban or edoxaban), for an indication other than VTE; or for antiplatelet agents except acetylsalicylic acid at a dosage <=100 mg/day; 4) Active bleeding or known significant bleeding risk; 5) Renal insufficiency with estimated creatinine clearance <30 ml/min/1.73m2; 6) Non-compliance or inability to adhere to treatment or to the follow-up visits; 7) Life expectancy less than 6 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is whether symptomatic VTE or PE-related death occurs<br /><br>within the first 6 months of anticoagulation therapy (yes/no). Recurrent<br /><br>symptomatic deep vein thrombosis (DVT) of the legs will be confirmed by a new<br /><br>non-compressible venous segment on compression ultrasonography or by a new<br /><br>filling defect on CT venography. Recurrent symptomatic PE will be objectively<br /><br>confirmed by a new filling defect on CT pulmonary angiography, or by a more<br /><br>proximal obstruction of a previously occluded pulmonary artery, or by a new<br /><br>segmental mismatch on ventilation-perfusion lung scan. Death related to PE is<br /><br>defined as death following acute, objectively confirmed symptomatic recurrent<br /><br>PE, or as sudden and unexplained death (without any other suspected cause), or<br /><br>as death occurring rapidly after worsening of dyspnea not explained by another<br /><br>cause.</p><br>
- Secondary Outcome Measures
Name Time Method