Acute Intermediate-Risk Pulmonary Embolism MedDRA version: 20.0 Level: HLT Classification code 10037379 Term: Pulmonary embolism and thrombosis System Organ Class: 100000004866
Conditions
Interventions
Trade Name: Pradaxa 110 mg
Product Name: Pradaxa 110 mg Hartkapseln
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: DABIGATRAN
CAS Number: 211914-51-1
Concentration unit: mg milligram(s)
Conce
Sponsors
University Medical Center of the Johannes Gutenberg University Mainz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 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: 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: 1) Pregnancy or women of childbearing potential who do not practice a medically accepted highly effective contraception during the trial and one month beyond; 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 the index PE episode; or for antiplatelet agents except a etylsalicylic 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine whether treatment of acute intermediate-risk PE (as defined by the inclusion and exclusion criteria) with parenteral anticoagulation for at least 72 hours after diagnosis, followed by dabigatran over 6 months, is effective and safe.;Secondary Objective: The secondary objective is to assess the recovery of right ventricular function over the first 6±1 days after the PE diagnosis, or upon discharge, and to evaluate its importance for the 6-month prognosis of patients with intermediate-risk PE.;Primary end point(s): The primary outcome is whether symptomatic VTE or PE-related death occurs within the first 6 months of anticoagulation therapy (yes/no). Symptomatic VTE and PE-related death are defined in chapter 2.2 of the Trial protocol.;Timepoint(s) of evaluation of this end point: 6 months after anticoagulation therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Recovery of RV function at 6±1 days after PE diagnosis, or upon discharge (whichever comes first), and at 6-month follow-up, as assessed by echocardiography; 2) Course of NT-proBNP levels during follow-up (measurement at baseline, 6±1 days or at discharge, and 6-month follow-up); 3) Death from any cause, or hemodynamic collapse or decompensation, within the first 30 days; 4) PE-related death, or PE-related hemodynamic collapse or decompensation, within the first 30 days; 5) Overall duration of hospital stay (index event and repeated hospitalizations due to PE [index or recurrent event] or to a bleeding event) within 6 months; 6) Death from any cause within 6 months.;Timepoint(s) of evaluation of this end point: 30 days, 6 months after PE diagnosis | — |
Countries
Austria, Belgium, France, Germany, Italy, Netherlands, Slovenia, Spain
Contacts
Public ContactCenter for Thrombosis & Hemostasis
University Medical Center of the Johannes Gutenberg University Mainz
Outcome results
None listed