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

NCT ID: NCT02946944

Last Updated: 2016-11-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2020-10-31

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

Conditions

Pulmonary Embolism; Intermediate-high Risk; Combination of Oral Anticoagulation Therapy and Sildenafil

Keywords

Pulmonary Embolism; sildenafil; oral anticoagulation therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

double drug therapy

Group Type: EXPERIMENTAL

Sildenafil/apixaban

Intervention Type: 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 .

mono drug therapy

Group Type: ACTIVE_COMPARATOR

apixaban

Intervention Type: 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 .

Interventions

Sildenafil/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 .

Intervention Type: 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.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 .

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Federal State Institution Academician E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rusmedtechnology

Novosibirsk, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Andrey Karpenko, MD/PhD

Role: CONTACT

Email: a_karpenko@meshalkin.ru

Alexey Cheban, MD

Role: CONTACT

Email: cheban_a@meshalkin.ru

Facility Contacts

Artem Rabtsun

Role: primary

Other Identifiers

NRICP-45734

Identifier Type: -

Identifier Source: org_study_id