Pilot randomized study of the sidlenafil efficacy in combination with oral anticoagulants in the treatment of patients with intermediate-high risk of pulmonary embolism
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
After arrival to the emergency department, a series of surveys to determine the risk of death from pulmonary embolism are carried out. Then angiography, tensiometry of SBCC, catheter thrombus fragmentation are scheduled. Then puncture of the right jugular vein is performed. PigTail catheter is inserted via guidewire into the pulmonary artery . Angiography of the pulmonary arteries is performed. Miller index is calculated. Catheter thrombus fragmentation is performed by a PigTail catheter. RV, RA pressures are measured. In the ICU heparin is prescribed (of 1000 units per hour) under the control of PTT (50-75s). The next day patients are randomizaed to assign them into 2 groups. Dual drug therapy is going to be administered to this group (experimental): sildenafil 30mg 3p \\ g + 10 mg apixaban 2p \\ d for 14 days. On the 7th day MSCT angiography of the pulmonary aretry with contrast and echocardiogram are performed. On the 14th day the controlechocardiogram is performed .
After arrival to the emergency department, a series of surveys to determine the risk of death from pulmonary embolism are carried out. Then angiography, tensiometry of SBCC, catheter thrombus fragmentation are scheduled. Then puncture of the right jugular vein is performed. PigTail catheter is inserted via guidewire into the pulmonary artery . Angiography of the pulmonary arteries is performed. Miller index is calculated. Catheter thrombus fragmentation is performed by a PigTail catheter. RV, RA pressures are measured. In the ICU heparin is prescribed (of 1000 units per hour) under the control of PTT (50-75s). The next day patients are randomizaed to assign them into 2 groups.Mono drug therapy is going to be administered to this group (active comparator): apixaban 10 mg 2p \\ d for 14 days. On the 7th day MSCT angiography of the pulmonary aretry with contrast and echocardiogram are performed. On the 14th day the controlechocardiogram is performed .
Federal State Institution Academician E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rusmedtechnology
Novosibirsk, Russia
RECRUITINGMSCT RV \ LV Index
on the 7th day of treatment RV \\ LV Index (calculated according to MSCT angiography of the pulmonary arteries)
Time frame: 7th day
Echocardiogram RV \ LV Index
Echocardiogram (an index of RV \\ LV) on 7th day
Time frame: 7th day
Echocardiogram RV \ LV Index
Echocardiogram (an index of RV \\ LV) on 14th day
Time frame: 14th day
Echocardiogram RV \ LV Index
Echocardiogram (an index of RV \\ LV) on one month
Time frame: one month
Echocardiogram pressure in the pulmonary artery
the average pressure in the pulmonary artery according to echocardiography
Time frame: one month
hemodynamic instability
in the hospital and within a month follow-up
Time frame: one month
death
in the hospital and within a month follow-up
Time frame: one month
bleeding
clinically significant bleeding on a scale HAS-BLED
Time frame: one month
recurrent venous thrombosis
recurrent venous thrombosis
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: one month
recurrent pulmonary embolism
recurrent pulmonary embolism.
Time frame: one month