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Bleeding Frequency Under Anticoagulant Treatment in Pulmonary Hypertension (HEMA-HTP)

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ClinicalTrials.gov Identifier: NCT02800941
Recruitment Status : Recruiting
First Posted : June 15, 2016
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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.


Condition or disease Intervention/treatment
Pulmonary Arterial Hypertension Drug: Oral anticoagulant treatment

Detailed Description:

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 (bleeding).

The only one study scaling the tolerance of anticoagulants for this population found major hemorrhagic levels discording with the clinical practice : really high for connectives associated to pulmonary arterial hypertension (PAHT), and lower in "simple" pulmonary embolism in CTE-PHT. These discoveries could belong to methodological failures of this study: a retrospective, monocentric one, without adjudication of events by an independent committee. Furthermore, there were no information about the existence of a validated indication for anticoagulant treatments.

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.


Study Type : Observational
Estimated Enrollment : 203 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bleeding Frequency Under Anticoagulant Treatment in Pulmonary Hypertension : HEMA-HTP Multicentric Study.
Actual Study Start Date : July 5, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019


Group/Cohort Intervention/treatment
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
The treatment is delivered according to the usual practice.
Other Names:
  • warfarin (Coumadine®)
  • fluindione (Préviscan®)
  • acenocoumarol (Sintrom®)




Primary Outcome Measures :
  1. Number of major bleeding (according to the International Society on Thrombosis and Haemostasis definition) [ Time Frame: 1 year ]
    Major bleedings (according to the International Society on Thrombosis and Haemostasis definition) will be notified during one year under oral anticoagulant treatment.


Secondary Outcome Measures :
  1. Number of clinically relevant bleedings [ Time Frame: 1 year ]
    Clinically relevant bleedings (major and non major ones) will be notified during one year under oral anticoagulant treatment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cohort of pulmonary hypertension patients receiving oral anticoagulant treatment.
Criteria

Inclusion Criteria:

  • Patient insured or entitled to a social security scheme;
  • Patient with confirmed pulmonary hypertension, followed in one of the three following centers: St-Etienne, Grenoble, Lyon;
  • 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.

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800941


Contacts
Contact: Laurent Bertoletti, PhD 04.77.82.91.21 ext +33 laurent.bertoletti@chu-st-etienne.fr
Contact: Carine Labruyere, CRA 04 77 12 04 69 ext +33 carine.labruyere@chu-st-etienne.fr

Locations
France
CHU de Grenoble Not yet recruiting
Grenoble, France, 38100
Contact: Christophe Pison, MD       christophe.pison@chu-grenoble.fr   
Principal Investigator: Christophe Pison, MD         
Hospices Civils de Lyon Not yet recruiting
Lyon, France, 69002
Contact: Jean François Mornex, MD       jean-francois.mornex@chu-lyon.fr   
Sub-Investigator: Jean François Mornex, MD         
Principal Investigator: Vincent Cottin, MD         
CHU de Saint-Etienne Recruiting
Saint-Etienne, France, 42055
Contact: Laurent Bertoletti, PhD    04 77 82 91 21 ext +33    laurent.bertoletti@chu-st-etienne.fr   
Principal Investigator: Laurent Bertoletti, PhD         
Sub-Investigator: Elodie De Magalhaes, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Principal Investigator: Laurent Bertoletti, PhD CHU de Saint-Etienne

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02800941     History of Changes
Other Study ID Numbers: 1608037
2016-001608-41 ( EudraCT Number )
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Pulmonary Arterial hypertension
Oral anticoagulants
Major bleedings

Additional relevant MeSH terms:
Hypertension
Hemorrhage
Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Anticoagulants
Acenocoumarol