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

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Unknown; Phase 1

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

Treatments: Drug: Sildenafil/apixaban; Drug: apixaban

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02946944

NRICP-45734

Details and patient eligibility

About

Pilot randomized study of the sidlenafil efficacy in combination with oral anticoagulants in the treatment of patients with intermediate-high risk of pulmonary embolism

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

double drug therapy

Experimental group

Treatment:

Drug: Sildenafil/apixaban

mono drug therapy

Active Comparator group

Treatment:

Drug: apixaban