Use of Ventavis in Patients With Postembolic Residual Pulmonary Hypertension

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Unknown; Phase 2

Conditions: Residual Pulmonary Hypertension

Treatments: Drug: Warfarin; Drug: Ventavis

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02238535

Ventavis_PRPH

Details and patient eligibility

About

To assess the effectiveness of the synthetic analogue of prostacyclin in postembolic residual pulmonary hypertension.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with pulmonary embolism after undergone surgical treatment (intravascular thrombolysis, catheter thrombus fragmentation)
• Patients with preserved thromboembolism in the pulmonary circulation system and mean pressure in the pulmonary artery of more than 25 mm Hg

Exclusion criteria

• Patient did not sign the informed consent.
• Mean pulmonary artery pressure after surgical treatment less than 25 mm Hg
• Age above 75 years.
• Patients with an increased risk of bleeding - including gastric ulcer and 12 duodenal ulcer in acute, hemorrhagic stroke.
• Severe coronary artery disease (unstable angina, myocardial infarction within the last 6 months).
• Acute heart failure or CHF IV in NYHA.
• Severe arrhythmias.
• Pregnancy, lactation.
• The presence of severe diseases of other organ systems that may result in death during the first year after surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Ventavis + Warfarin

Active Comparator group

Description:

Patients in this group will receive drug treatment - ventavis (2,0 ml - 6 time per day - during 5 days). Warfarin - INR=2,0-3,0

Treatment:

Drug: Warfarin

Drug: Ventavis

Warfarin

Active Comparator group

Description:

Patients in this group will receive drug treatment according to up-to-date guidelines (Warfarin - INR=2,0-3,0)

Treatment:

Drug: Warfarin