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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 deaths

Number 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

Page last updated: August 23, 2015

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