Sidlenafil in Combination With Oral Anticoagulants in Patients With Intermediate-high Risk of Pulmonary Embolism

Phase 1

• Conditions: Pulmonary Embolism; Combination of Oral Anticoagulation Therapy and Sildenafil; Intermediate-high Risk
• Interventions: Drug: apixaban; Drug: Sildenafil/apixaban

• Registration Number: NCT02946944
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-10
• Study Start: 2016-10
• Study First Submitted: 2016-10-20
• Study First Submitted QC: 2016-10-25
• Study First Posted: 2016-10-27
• Last Update Submitted: 2016-10-29
• Last Update Posted: 2016-11-01
• Primary Completion: 2020-10
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mono drug therapy	apixaban	-
double drug therapy	Sildenafil/apixaban	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
death	one month	in the hospital and within a month follow-up
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
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
Echocardiogram RV \ LV Index	one month	Echocardiogram (an index of RV \\ LV) on one month

Trial Locations

Locations (1)

Federal State Institution Academician E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rusmedtechnology; 🇷🇺 Novosibirsk, Russian Federation