Pradaxa or Warfarin for Prevention of Recurrent VTE in Patients With Angiographically Confirmed Acute Massive Pulmonary Embolism undergoIng Endovascular Mechanical Fragmentation and Thrombolytic Therapy

Inclusion Criteria:

• Men and women aged > 18 years

• Angiographically confirmed acute massive pulmonary embolism with involvement ofCentral pulmonary arteries.

• endovascular mechanical thrombus fragmentation + thrombolytic therapy (usingrecombinant tissue activator of plasminogen), performed for treatment of theabove-mentioned pulmonary embolism in less than 48 hours before randomization. Thepatient should be randomized no earlier than 24 hours after procedures endovascularmechanical thrombus fragmentation + thrombolytic therapy

• Written informed consent signed by patient.

Exclusion Criteria:

• Signs of hemodynamic instability (i.e. systolic blood pressure <100 mm Hg.St. orepisode of systolic blood pressure fall for ≥40 mm Hg. / or heart rate > 110 lastingmore than 15 min) or need for ventilatory support within 12 hours prior torandomisation.

• The indication for oral anticoagulation, associated with others disease.

• malignant neoplasm of any location

• Contraindications to warfarin or pradaxa according to Russian Instructions for medicaluse of these drugs

• Indications for concomitant treatment with antiplatelet agents

• Any stroke within 6 months before randomization

• Intracranial hemorrhage in anamnesis

• Active bleeding, bleeding diathesis.

• Clinically significant bleeding within the last 30 days.

• Trauma or extensive surgery within 1 month before randomization or surgery planned inthe next 6 months after randomization.

• Intracranial pathology: tumor, arteriovenous fistula or aneurysm.

• Gastrointestinal bleeding in the previous 3 months.

• Gastric ulcer or duodenal ulcer with clinical manifestations or endoscopicallyidentified acute ulcer without signs of scarring during previous 30 days.

• Uncontrolled hypertension (systolic blood pressure> 180 mm Hg. and / or diastolicblood pressure> 100 mm.hg in patients receiving antihypertensive drugs).

• Pregnancy, lactation.

• Life expectancy <6 months.

• Clinically significant liver disease.

• Creatinine clearance (estimated by Cockcroft-Gault) <30 ml / min.

• hemoglobin level <90 g/l), thrombocytopenia <100x10^9 / L.

• Patients who, in the opinion of the researcher, are not suitable for inclusion in thestudy, for example, due to the low likelihood of doctor's recommendations following.

• Long-term use of NSAIDs

• Current participation in another clinical study.

• Allergic to contrast substance or radioisotope drugs used in procedures to assessendpoints of the study, which according to researchers, may be a contraindication tothe implementation of these research methods.