NCT02800941

Brief Summary

Pulmonary hypertension (PHT) patients often receive long term oral anticoagulants. If the indication is strong, in the secondary chronic thrombo-embolism pulmonary hypertension (CTE-PHT) prevention, the frequent prescription (50 to 90% of patients) contrasts with their low level of proof in the PHT. Last but not least, anticoagulants are known to be the principal cause of iatrogenic hospitalization (major bleeding). In this study, patients are all followed during one year, to determine the annual frequency of major bleedings (according to the International Society on Thrombosis and Haemostasis (ISTH) international definition). Each event notified is validated by an independent committee for clinical events.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 5, 2017

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2022

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2023

Completed
Last Updated

June 4, 2024

Status Verified

June 1, 2024

Enrollment Period

5.2 years

First QC Date

June 10, 2016

Last Update Submit

June 3, 2024

Conditions

Pulmonary Arterial Hypertension

Keywords

Pulmonary Arterial hypertensionOral anticoagulantsMajor bleedings

Outcome Measures

Primary Outcomes (1)

  • Number of major bleeding (according to the International Society on Thrombosis and Haemostasis definition)

    Major bleedings (according to the International Society on Thrombosis and Haemostasis definition) will be notified during one year under oral anticoagulant treatment.

    1 year

Secondary Outcomes (1)

  • Number of clinically relevant bleedings

    1 year

Study Arms (1)

Oral anticoagulant treatment

Patients with pulmonary hypertension are treated with oral anticoagulants according to the usual practice. Patients have follow-up at 3, 6 and 12 months.

Drug: Oral anticoagulant treatment

Interventions

Oral anticoagulant treatmentDRUG

The treatment is delivered according to the usual practice.

Also known as: warfarin (Coumadine®), fluindione (Préviscan®), acenocoumarol (Sintrom®)
Oral anticoagulant treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cohort of pulmonary hypertension patients receiving oral anticoagulant treatment.

You may qualify if:

  • Patient insured or entitled to a social security scheme;
  • Patient with confirmed pulmonary hypertension;
  • Pulmonary hypertension among the following etiological diagnosis: idiopathic PAH, PAH associated with appetite suppressants, PAH associated with connective, or Chronic Thrombo-embolism Pulmonary Hypertension;
  • Patients receiving oral anticoagulants.

You may not qualify if:

  • Impossible following;
  • Bleeding at baseline;
  • Life expectancy of less than 3 months;
  • Pulmonary hypertension in Group 2, Group 3 (in the absence of associated pulmonary embolism) and Group 5 (in the absence of associated pulmonary embolism).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

CHU de Grenoble

Grenoble, 38100, France

Location

Hospices Civils de Lyon

Lyon, 69002, France

Location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

WarfarinfluindioneAcenocoumarol

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Laurent Bertoletti, PhD

    CHU de Saint-Etienne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2016

First Posted

June 15, 2016

Study Start

July 5, 2017

Primary Completion

September 13, 2022

Study Completion

September 5, 2023

Last Updated

June 4, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)