A Phase 1 interventional study of Sildenafil/apixaban and apixaban in Pulmonary Embolism, Intermediate-high Risk and Combination of Oral Anticoagulation Therapy and Sildenafil, sponsored by Meshalkin Research Institute of Pathology of Circulation. Status unknown at 1 site in Russian Federation. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-11-01.
Sponsored by Meshalkin Research Institute of Pathology of Circulation · Phase 1, Interventional, and Treatment
Pilot randomized study of the sidlenafil efficacy in combination with oral anticoagulants in the treatment of patients with intermediate-high risk of pulmonary embolism
739 studies on the registry are indexed under Pulmonary Embolism; 159 are open to participants now.
This study's planned enrollment of 100 is below the median of 150 across 381 interventional studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →Meshalkin Research Institute of Pathology of Circulation is the lead sponsor of 114 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Sildenafil/apixaban
Drug: apixaban
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 .
MSCT 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
Time frame: one month
recurrent pulmonary embolism
recurrent pulmonary embolism.
Time frame: one month
This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Meshalkin Research Institute of Pathology of Circulation