Use of Ventavis in Patients With Postembolic Residual Pulmonary Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 6 October 2015
• Main ID: NCT02238535
• Date of registration: 03/09/2014
• Prospective Registration: No
• Primary sponsor: Meshalkin Research Institute of Pathology of Circulation
• Public title: Use of Ventavis in Patients With Postembolic Residual Pulmonary Hypertension
• Scientific title: Use of Ventavis in Patients With Postembolic Residual Pulmonary Hypertension
• Date of first enrolment: September 2014
• Target sample size: 60
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02238535
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Russian Federation

Contacts

• Name: Yulia Klevanets, MD

• Name: Yulia Klevanets, MD

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Residual Pulmonary Hypertension

Intervention(s)

Drug: Ventavis

Drug: Warfarin

Primary Outcome(s)

Pulmonary hypertension [Time Frame: 6 months]

Secondary Outcome(s)

Number of venous thromboembolisms [Time Frame: 6 months]

Number of deaths [Time Frame: 6 months]

Number of recurrent pulmonary embolisms [Time Frame: 6 months]

Secondary ID(s)

Ventavis_PRPH

Source(s) of Monetary Support

Please refer to primary and secondary sponsors