Use of Ventavis in Patients With Postembolic Residual Pulmonary Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-10-31

Brief Summary

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

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Detailed Description

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Conditions

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Residual Pulmonary Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ventavis + 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

Group Type ACTIVE_COMPARATOR

Ventavis

Intervention Type DRUG

Warfarin

Intervention Type DRUG

Warfarin

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

Group Type ACTIVE_COMPARATOR

Warfarin

Intervention Type DRUG

Interventions

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Ventavis

Intervention Type DRUG

Warfarin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No