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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03157154
Other study ID # RC17_0150
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 27, 2017
Est. completion date July 30, 2017

Study information

Verified date January 2020
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Life expectancy of haemophilia patients (specially severe) has dramatically increase in the last decades, which lead to the apparition of aging diseases such as cardiovascular disease, with the potential bleeding risk of antiplatelet therapies and anticoagulants.

The primary endpoint of the study is to evaluate this bleeding risk in haemophilia patients (all severity) with such treatment in comparison to non treated patients, according to the number of bleeding events in the last year reported by the haemophilia patients under study treatment (antiplatelet and anticoagulant) in comparison to haemophilia patients free of such treatment. The main hypothesis is that antiplatelet and anticoagulant therapy can be safely used in minor haemophilia patients but might lead to increase bleeding risk in other haemophilia patients.

Secondary endpoint consist in:

- Evaluate the impact of know cardio-vascular risk in haemophilia patients (Odd ratios=OR)

- Evaluate the number of sever bleeding event in patient under study treatments compared to the control group

- Evaluate the overall consumption of factor VIII or IX supply in patients under study treatments compared to control group

- Estimate the stenosis relapse risk in haemophilia patients with arterial STENT

- Estimate the embolic risk of haemophilia patients with atrial fibrillation

Population description:

Haemophilia patients (man, all severity)

Age above 50 years, followed during the last 5 years in one of the study centre


Recruitment information / eligibility

Status Completed
Enrollment 259
Est. completion date July 30, 2017
Est. primary completion date July 30, 2017
Accepts healthy volunteers
Gender Male
Age group 50 Years and older
Eligibility Inclusion Criteria:

- Male

- Age above 50 years

- Hemophilia A or B carriers

- Followed within the 5 last years in one of the research center

Exclusion Criteria:

- Jurisdictional prevention procedures

- Other medical condition that might interfere with the bleeding risk (Willebrand's disease, Other coagulation factor deficiencies, haematological malignancies, …)

- Other drugs that might interfere with the bleeding risk (Serotonin reuptake inhibitors)

- Patient refusal

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Non interventional study
A query form to all concerned patients by each investigating centre will be send

Locations

Country Name City State
France Angers University Hospital Angers
France Brest University Hospital Brest
France Le Mans Hospital La Mans
France Lyon University Hospital Lyon
France Rennes University Hospital Rennes
France Tours University Hospital Tours

Sponsors (1)

Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of bleeding occurrences last 12 months
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