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

Primary Purpose

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

Status

Unknown status

Phase

Phase 1

Locations

Russian Federation

Study Type

Interventional

Intervention

Sildenafil/apixaban

apixaban

About this trial

This is an interventional treatment trial for Pulmonary Embolism focused on measuring Pulmonary Embolism, sildenafil, oral anticoagulation therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

double drug therapy

mono drug therapy

Arm Description

Outcomes

Primary Outcome Measures

MSCT RV \ LV Index

on the 7th day of treatment RV \ LV Index (calculated according to MSCT angiography of the pulmonary arteries)

Secondary Outcome Measures

Echocardiogram RV \ LV Index

Echocardiogram (an index of RV \ LV) on 7th day

Echocardiogram RV \ LV Index

Echocardiogram (an index of RV \ LV) on 14th day

Echocardiogram RV \ LV Index

Echocardiogram (an index of RV \ LV) on one month

Echocardiogram pressure in the pulmonary artery

the average pressure in the pulmonary artery according to echocardiography

hemodynamic instability

in the hospital and within a month follow-up

death

in the hospital and within a month follow-up

bleeding

clinically significant bleeding on a scale HAS-BLED

recurrent venous thrombosis

recurrent pulmonary embolism

recurrent pulmonary embolism.

Full Information

NCT ID

NCT02946944

First Posted

October 20, 2016

Last Updated

October 29, 2016

Sponsor

Meshalkin Research Institute of Pathology of Circulation

1. Study Identification

Unique Protocol Identification Number

NCT02946944

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Unknown status

Study Start Date

October 2016 (undefined)

Primary Completion Date

October 2020 (Anticipated)

Study Completion Date

October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Meshalkin Research Institute of Pathology of Circulation

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Pulmonary Embolism, sildenafil, oral anticoagulation therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

double drug therapy

Arm Type

Experimental

Arm Title

mono drug therapy

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Sildenafil/apixaban

Intervention Description

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

Intervention Name(s)

apixaban

Intervention Description

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 .

Primary Outcome Measure Information:

Title

MSCT RV \ LV Index

Description

on the 7th day of treatment RV \ LV Index (calculated according to MSCT angiography of the pulmonary arteries)

Time Frame

7th day

Secondary Outcome Measure Information:

Title

Echocardiogram RV \ LV Index

Description

Echocardiogram (an index of RV \ LV) on 7th day

Time Frame

7th day

Title

Echocardiogram RV \ LV Index

Description

Echocardiogram (an index of RV \ LV) on 14th day

Time Frame

14th day

Title

Echocardiogram RV \ LV Index

Description

Echocardiogram (an index of RV \ LV) on one month

Time Frame

one month

Title

Echocardiogram pressure in the pulmonary artery

Description

the average pressure in the pulmonary artery according to echocardiography

Time Frame

one month

Title

hemodynamic instability

Description

in the hospital and within a month follow-up

Time Frame

one month

Title

death

Description

in the hospital and within a month follow-up

Time Frame

one month

Title

bleeding

Description

clinically significant bleeding on a scale HAS-BLED

Time Frame

one month

Title

recurrent venous thrombosis

Description

recurrent venous thrombosis

Time Frame

one month

Title

recurrent pulmonary embolism

Description

recurrent pulmonary embolism.

Time Frame

one month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andrey Karpenko, MD/PhD

a_karpenko@meshalkin.ru

First Name & Middle Initial & Last Name or Official Title & Degree

Alexey Cheban, MD

cheban_a@meshalkin.ru

Facility Information:

Facility Name

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

City

Novosibirsk

ZIP/Postal Code

630055

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Artem Rabtsun

Phone

+79137078354

a_rabtsun@meshalkin.ru

12. IPD Sharing Statement

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

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