This prospective, multicenter, multinational, phase IV, interventional single-armed (management) trial will focus on the safety, efficacy and cost-effectiveness of a new oral anticoagulant in the treatment of patients with acute intermediate-risk PE based on validated imaging (echocardiographic or CT angiographic) and laboratory biomarker (circulating levels of cardiac troponins and natriuretic peptides) parameters and their combinations.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Low molecular weight heparin for 72 hours followed by 6 months of dabigatran
Center for Thrombosis and Hemostasis, University Medical Center Mainz
Mainz, Germany
Occurrence of symptomatic venous thromboembolism (VTE) or pulmonary embolism (PE) related death (yes/no)
Time frame: 6 months
Recovery of right ventricle (RV) function
Time frame: 6±1 days or upon discharge (whichever comes first), 6 months
Temporal pattern of changes in NT-proBNP (N-terminal prohormone of brain natriuretic peptide) levels
Time frame: 6±1 days or upon discharge (whichever comes first), 6 months
Death from any cause
Time frame: 30 days
Pulmonary embolism (PE) related death, or PE-related or hemodynamic collapse or decompensation
Time frame: 30 days
Overall duration of hospital stay
Time frame: 6 months
Major bleeding
Time frame: 6 months
Clinically relevant bleeding
Time frame: 6 months
Serious adverse events (SAE)
Time frame: 72 hours, 30 days, 6 months
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