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 20, 2020
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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 |
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Pulmonary Arterial Hypertension | Drug: Oral anticoagulant treatment |
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 2021 |
Estimated Study Completion Date : | December 2022 |

Group/Cohort | Intervention/treatment |
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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.
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Drug: Oral anticoagulant treatment
The treatment is delivered according to the usual practice.
Other Names:
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- 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.
- 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 |
Inclusion Criteria:
- 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.
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).

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
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 |
France | |
CHU Clermont-Ferrand | Not yet recruiting |
Clermont-Ferrand, France | |
Principal Investigator: Claire DAUPHIN, MD | |
Sub-Investigator: Romain TRESORIER, MD | |
CHU de Grenoble | Recruiting |
Grenoble, France, 38100 | |
Principal Investigator: Christophe Pison, MD | |
Sub-Investigator: Hélène Bouvaist, MD | |
Hospices Civils de Lyon | Recruiting |
Lyon, France, 69002 | |
Principal Investigator: Vincent Cottin, MD | |
Sub-Investigator: Ségolène Turquier, MD | |
Sub-Investigator: Clément Deudon, MD | |
Sub-Investigator: Julie Traclet, MD | |
Sub-Investigator: Kais Ahmad, 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 | |
Sub-Investigator: Sandrine Accassat, MD | |
Sub-Investigator: Cécile Duvillard, MD | |
Sub-Investigator: Judith Catella, MD | |
Sub-Investigator: Jean-Baptiste Gaultier, MD |
Principal Investigator: | Laurent Bertoletti, PhD | CHU de Saint-Etienne |
Responsible Party: | Centre Hospitalier Universitaire de Saint Etienne |
ClinicalTrials.gov Identifier: | NCT02800941 |
Other Study ID Numbers: |
1608037 2016-001608-41 ( EudraCT Number ) |
First Posted: | June 15, 2016 Key Record Dates |
Last Update Posted: | October 20, 2020 |
Last Verified: | October 2020 |
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 |
Pulmonary Arterial hypertension Oral anticoagulants Major bleedings |
Hypertension, Pulmonary Hypertension Hemorrhage Vascular Diseases Cardiovascular Diseases Pathologic Processes |
Lung Diseases Respiratory Tract Diseases Warfarin Anticoagulants Acenocoumarol Fluindione |