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Pilot randomized study of the sidlenafil efficacy in combination with oral anticoagulants in the treatment of patients with intermediate-high risk of pulmonary embolism
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| double drug therapy | Experimental |
| |
| mono drug therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sildenafil/apixaban | Drug | 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 . |
| Measure | Description | Time Frame |
|---|---|---|
| MSCT RV \ LV Index | on the 7th day of treatment RV \ LV Index (calculated according to MSCT angiography of the pulmonary arteries) | 7th day |
| Measure | Description | Time Frame |
|---|---|---|
| Echocardiogram RV \ LV Index | Echocardiogram (an index of RV \ LV) on 7th day | 7th day |
| Echocardiogram RV \ LV Index | Echocardiogram (an index of RV \ LV) on 14th day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrey Karpenko, MD/PhD | Contact | a_karpenko@meshalkin.ru | ||
| Alexey Cheban, MD | Contact | cheban_a@meshalkin.ru |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal State Institution Academician E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rusmedtechnology | Recruiting | Novosibirsk | 630055 | Russia |
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| apixaban | Drug | 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 . |
|
| 14th day |
| Echocardiogram RV \ LV Index | Echocardiogram (an index of RV \ LV) on one month | one month |
| Echocardiogram pressure in the pulmonary artery | the average pressure in the pulmonary artery according to echocardiography | one month |
| hemodynamic instability | in the hospital and within a month follow-up | one month |
| death | in the hospital and within a month follow-up | one month |
| bleeding | clinically significant bleeding on a scale HAS-BLED | one month |
| recurrent venous thrombosis | recurrent venous thrombosis | one month |
| recurrent pulmonary embolism | recurrent pulmonary embolism. | one month |
|
| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| C522181 | apixaban |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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