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

Pulmonary Embolism Clinical Trial

— PSCAT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02946944
• Other study ID #: NRICP-45734
• Status: Recruiting
• Phase: Phase 1
• First received: October 20, 2016
• Last updated: October 29, 2016
• Start date: October 2016
• Est. completion date: October 2020

Study information

• Verified date: October 2016
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: Andrey Karpenko, MD/PhD
• Email: a_karpenko[@]meshalkin.ru
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• 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 .
• 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 .

Locations

Country	Name	City	State
Russian Federation	Federal State Institution Academician E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rusmedtechnology	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MSCT RV \ LV Index	on the 7th day of treatment RV \ LV Index (calculated according to MSCT angiography of the pulmonary arteries)	7th day	Yes
Secondary	Echocardiogram RV \ LV Index	Echocardiogram (an index of RV \ LV) on 7th day	7th day	Yes
Secondary	Echocardiogram RV \ LV Index	Echocardiogram (an index of RV \ LV) on 14th day	14th day	Yes
Secondary	Echocardiogram RV \ LV Index	Echocardiogram (an index of RV \ LV) on one month	one month	Yes
Secondary	Echocardiogram pressure in the pulmonary artery	the average pressure in the pulmonary artery according to echocardiography	one month	Yes
Secondary	hemodynamic instability	in the hospital and within a month follow-up	one month	Yes
Secondary	death	in the hospital and within a month follow-up	one month	Yes
Secondary	bleeding	clinically significant bleeding on a scale HAS-BLED	one month	Yes
Secondary	recurrent venous thrombosis	recurrent venous thrombosis	one month	Yes
Secondary	recurrent pulmonary embolism	recurrent pulmonary embolism.	one month	Yes