|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
20 February 2023 |
|
Main ID: |
NCT02800941 |
|
Date of registration:
|
10/06/2016 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Bleeding Frequency Under Anticoagulant Treatment in Pulmonary Hypertension
HEMA-HTP |
|
Scientific title:
|
Bleeding Frequency Under Anticoagulant Treatment in Pulmonary Hypertension : HEMA-HTP Multicentric Study. |
|
Date of first enrolment:
|
July 5, 2017 |
|
Target sample size:
|
203 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT02800941 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Laurent Bertoletti, PhD |
|
Address:
|
|
|
Telephone:
|
04.77.82.91.21 |
|
Email:
|
laurent.bertoletti@chu-st-etienne.fr |
|
Affiliation:
|
|
|
|
Name:
|
Laurent Bertoletti, PhD |
|
Address:
|
|
|
Telephone:
|
04 77 82 91 21 |
|
Email:
|
laurent.bertoletti@chu-st-etienne.fr |
|
Affiliation:
|
|
|
|
Name:
|
Laurent Bertoletti, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
CHU de Saint-Etienne |
|
|
Key inclusion & exclusion criteria
|
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).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Pulmonary Arterial Hypertension
|
|
Intervention(s)
|
|
Drug: Oral anticoagulant treatment
|
|
Primary Outcome(s)
|
|
Number of major bleeding (according to the International Society on Thrombosis and Haemostasis definition)
[Time Frame: 1 year]
|
|
Secondary Outcome(s)
|
|
Number of clinically relevant bleedings
[Time Frame: 1 year]
|
|
Secondary ID(s)
|
|
1608037
|
|
2016-001608-41
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|