Use of Ventavis in Patients With Postembolic Residual Pulmonary Hypertension
Information source: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Residual Pulmonary Hypertension
Intervention: Ventavis (Drug); Warfarin (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Meshalkin Research Institute of Pathology of Circulation Overall contact: Yulia Klevanets, MD, Phone: +79139443607, Email: klevanetc@yandex.ru
Summary
To assess the effectiveness of the synthetic analogue of prostacyclin in postembolic
residual pulmonary hypertension.
Clinical Details
Official title: Use of Ventavis in Patients With Postembolic Residual Pulmonary Hypertension
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Pulmonary hypertension
Secondary outcome: Number of deathsNumber of recurrent pulmonary embolisms Number of venous thromboembolisms
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
Yulia Klevanets, MD, Phone: +79139443607, Email: klevanetc@yandex.ru
State Research Institute of Circulation Pathology, Novosibirsk 630055, Russian Federation; Recruiting Yulia Klevanets, MD, Phone: +79139443607, Email: klevanetc@yandex.ru
Additional Information
Starting date: September 2014
Last updated: September 11, 2014
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