Clinical trial NCT02946944: Sidlenafil in Combination With Oral Anticoagulants in Patients With Intermediate-high Risk of Pulmonary Embolism
Official title: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pulmonary Embolism
Intermediate-high Risk
Combination of Oral Anticoagulation Therapy and Sildenafil
Keywords: Pulmonary Embolism
sildenafil
oral anticoagulation therapy
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2016-10-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: MSCT RV \ LV Index
timeFrame: 7th day
Secondary outcomes:
measure: Echocardiogram RV \ LV Index
timeFrame: 7th day
measure: Echocardiogram RV \ LV Index
timeFrame: 14th day
measure: Echocardiogram RV \ LV Index
timeFrame: one month
measure: Echocardiogram pressure in the pulmonary artery
timeFrame: one month
measure: hemodynamic instability
timeFrame: one month
measure: death
timeFrame: one month
measure: bleeding
timeFrame: one month
measure: recurrent venous thrombosis
timeFrame: one month
measure: recurrent pulmonary embolism
timeFrame: one month
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Federal State Institution Academician E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rusmedtechnology
Study officials:
References: