Use of Ventavis in Patients With Postembolic Residual Pulmonary Hypertension

Phase 2

• Conditions: Residual Pulmonary Hypertension
• Interventions: Drug: Ventavis; Drug: Warfarin

• Registration Number: NCT02238535
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-03
• Study First Submitted QC: 2014-09-11
• Study First Posted: 2014-09-12
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-21
• Last Update Posted: 2015-09-23
• Primary Completion: 2016-03
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Pulmonary hypertension	6 months	The average pressure in the pulmonary artery trunk (according to direct tensiometry before Ventavis therapy, after the therapy according to transthoracic echocardiography and six months after discharge (transthoracic echocardiography).

Secondary Outcome Measures

Name	Time	Method
Number of deaths	6 months
Number of recurrent pulmonary embolisms	6 months
Number of venous thromboembolisms	6 months

Trial Locations

Locations (1)

State Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Russian Federation