Combination of Oral Anticoagulation Therapy and Sildenafil, Intermediate-high Risk, Pulmonary Embolism
Conditions
Keywords
Pulmonary Embolism, sildenafil, oral anticoagulation therapy
Brief summary
Pilot randomized study of the sidlenafil efficacy in combination with oral anticoagulants in the treatment of patients with intermediate-high risk of pulmonary embolism
Interventions
DRUGSildenafil/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 .
DRUGapixaban
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 .
Sponsors
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* pulmonary embolism confirmed by CT scan with contrast, with localization of thrombusa in at least one main or proximal lobar pulmonary artery. * Right-left ventricular ratio (RV / LV) ≥1 derived from the apical four-chamber view * Who gave written informed consent to participate in research
Exclusion criteria
* Age \<18 or \>80 years * Symptoms of pulmonary embolism\> 14 days * Inadequate echocardiographic image quality in the apical four-chamber projection, which limits the measurement of RV / LV ratio * A significant risk of bleeding * The administration of thrombolytic drugs within the previous 4 days * Active bleeding * Known coagulopathy * Thrombocytopenia \<100,10\^9 / l * Previous use of vitamin K antagonists with an INR\> 2.5 at admission * History of any intracranial or spinal surgery or trauma or intracranial / spinal bleeding * Intracranial neoplasm * Arteriovenous malformations or aneurysms * GIH \<3 months * Cataract Surgery * Obstetrical manipulation * Cardiopulmonary resuscitation needed. * Other invasive procedures \<10 days * Allergy, hypersensitivity, thrombocytopenia to heparin or tissue plasminogen activator * Allergy to iodine contrast * A well-known right-left cardiac shunt, for example, a large patent foramen ovale, or atrial septal defect; large (\> 10 mm), or a blood clot in right atrium/right ventricle * Systolic blood pressure \<90 mm Hg for at least 15 minutes, or fall of systolic blood pressure is not less than 40 mm Hg for at least 15 min., with evidence of organ hypoperfusion (cold extremities or low diuresis \<30 mL / h, or confusion), or the need for administration of catecholamines to maintain adequate perfusion of organs and systolic blood pressure\> 90 mm Hg * Severe hypertension (systolic\> 180 mm Hg or diastolic\> 105 mm Hg.). * Pregnancy, lactation, delivery\<30 days * Participation in any other study (drug or device) * Life expectancy \<90 days * Refusal to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MSCT RV \ LV Index | 7th day | on the 7th day of treatment RV \\ LV Index (calculated according to MSCT angiography of the pulmonary arteries) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Echocardiogram pressure in the pulmonary artery | one month | the average pressure in the pulmonary artery according to echocardiography |
| hemodynamic instability | one month | in the hospital and within a month follow-up |
| death | one month | in the hospital and within a month follow-up |
| Echocardiogram RV \ LV Index | 7th day | Echocardiogram (an index of RV \\ LV) on 7th day |
| recurrent venous thrombosis | one month | recurrent venous thrombosis |
| recurrent pulmonary embolism | one month | recurrent pulmonary embolism. |
| bleeding | one month | clinically significant bleeding on a scale HAS-BLED |
Countries
Russia
Contacts
Primary ContactAndrey Karpenko, MD/PhD
Backup ContactAlexey Cheban, MD
Outcome results
None listed