Use of Ventavis in Patients With Postembolic Residual Pulmonary Hypertension

September 21, 2015 updated by: Meshalkin Research Institute of Pathology of Circulation
To assess the effectiveness of the synthetic analogue of prostacyclin in postembolic residual pulmonary hypertension.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Novosibirsk, Russian Federation, 630055
        • Recruiting
        • State Research Institute of Circulation Pathology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Drug: Warfarin
Drug: Ventavis
Active Comparator: Warfarin
Patients in this group will receive drug treatment according to up-to-date guidelines (Warfarin - INR=2,0-3,0)
Drug: Warfarin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary hypertension
Time Frame: 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).
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of deaths
Time Frame: 6 months
6 months
Number of recurrent pulmonary embolisms
Time Frame: 6 months
6 months
Number of venous thromboembolisms
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

September 3, 2014

First Submitted That Met QC Criteria

September 11, 2014

First Posted (Estimate)

September 12, 2014

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 21, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ventavis_PRPH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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