Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05804734
Status:
COMPLETED
Last Update Posted:
2023-04-07
First Post:
2023-03-27
Brief Title:
Vitamin K Antagonist Versus Direct Oral Anticoagulant Treatments in Hemophilia
Sponsor:
Groupe Maladies hémorragiques de Bretagne
Organization:
Groupe Maladies hémorragiques de Bretagne
Study Overview
Official Title:
Vitamin K Antagonist Versus Direct Oral Anticoagulant Treatments in Hemophilia
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KADOAH
Brief Summary:
Hemophilia is a rare X-linked bleeding disorder responsible for deficiency of coagulation factor VIII FVIII or IX FIX The main clinical manifestation is increased bleeding throughout the life which is directly correlated to the severity of the hemophilia either mild FVIIIFIX 6-40 moderate FVIIIFIX 1-5 or severe FVIIIFIX1 Thanks to new therapies and long-term specialized follow-up by hemophilia treatment centers HTCs the life expectancy of patients with hemophilia PWH has improved considerably even reaching that of the general population 1
Healthcare professionals are so more confronted to PWH with age-related pathologies in particular cardiovascular pathologies such as atrial fibrillation acute coronary syndromes or thromboembolic events arterial or venous It is now recommended in PWH that an anticoagulant treatment AC be prescribed as in the general population 234 The recently published COCHE study demonstrated a significantly increased risk of bleeding in PWH receiving antithrombotic treatment This bleeding risk depended significantly on the type of antithrombotic treatment which was higher for anticoagulant vs antiplatelet drugs on basal levels of FVIII or FIX and on the HAS-BLED score 5
Nowadays in the general population among anticoagulant drugs direct oral anticoagulants DOACs are preferred to vitamin K antagonist KVA thanks to their reduced risk of bleeding particularly intracerebral bleeding and better anticoagulant stability over time 6 However we do not yet know precisely whether DOACs could occupy the same place in the PWH population because of the lack of evidence-based data due to the very small number of these patients although some authors already recommend them over KVA The KADOAH study was therefore set up to try to provide initial elements for future recommendations Its main objective was to compare the level of bleeding risk of PWH treated with VKA vs DOACs
Healthcare professionals are so more confronted to PWH with age-related pathologies in particular cardiovascular pathologies such as atrial fibrillation acute coronary syndromes or thromboembolic events arterial or venous It is now recommended in PWH that an anticoagulant treatment AC be prescribed as in the general population 234 The recently published COCHE study demonstrated a significantly increased risk of bleeding in PWH receiving antithrombotic treatment This bleeding risk depended significantly on the type of antithrombotic treatment which was higher for anticoagulant vs antiplatelet drugs on basal levels of FVIII or FIX and on the HAS-BLED score 5
Nowadays in the general population among anticoagulant drugs direct oral anticoagulants DOACs are preferred to vitamin K antagonist KVA thanks to their reduced risk of bleeding particularly intracerebral bleeding and better anticoagulant stability over time 6 However we do not yet know precisely whether DOACs could occupy the same place in the PWH population because of the lack of evidence-based data due to the very small number of these patients although some authors already recommend them over KVA The KADOAH study was therefore set up to try to provide initial elements for future recommendations Its main objective was to compare the level of bleeding risk of PWH treated with VKA vs DOACs
Detailed Description:
The KADOAH study is an observational retrospective and multicenter case-control study conducted in Hemophilia Treatment Centers HTC of the French Grand-Ouest interregion including HTCs of Brest Caen Le Mans Nantes Rennes and Rouen
Objectives of the KADOAH study are
To compare the risk of bleeding events of 2 types of long-term anticoagulant treatment vitamin K antagonists VKA versus Direct Oral Anticoagulants DOAC in patients with hemophilia
To describe the different types of bleeding events that occur during anticoagulant treatments in patients with hemophilia
To investigate for the influence of the HAS-BLED score on the risk of bleeding events in patients with hemophilia receiving a long-term anticoagulant treatment
Inclusion criteria
Cases
Males at any ages with hemophilia of any severity and of any type
Patients having received or receiving a long-term anticoagulant treatment during at least 6 consecutive months during the period from 2012 to 2021
Regular follow-up in a hemophilia treatment center
Controls cross-matched with cases on
Age - 5 years
Hemophilia type either A or B
Hemophilia severity for mild hemophilia same basal factor level - 5
HAS-BLED score same score - 1
Exclusion criteria
Lost to medical follow-up
Refusal to participate in the study
Unable to understand the studys French letter of non-opposition and information
Collected data
All data collected in this study were issued from the medical files at the moment of the inclusion in the study They include
The age
The hemophilias type
The hemophilias severity and last basal factor VIII or IX level
The treatment with anticoagulant drug for cases including
Type of drug either VKA or DOAC
Duration of treatments
Treatments dosages
Compliance of treatments
Indications
If stopped prematurely reasons for stopping
The occurrence of severe bleeding events SBE following the ISTH definition 7
The number of SBE per patient
The types of SBE
The treatment of SBE
The HAS-BLED score calculated with the presence or absence of the following items
High arterial pressure
Abnormal renal andor liver functions
Hemorrhagic stroke
Bleeding antecedent
Age 65 years
Treatments altering the hemostasis out of the anticoagulants andor alcohol intoxication
The CHA2DS-VASc score calculated with the presence or absence of the following items
Cardiac insufficiencyleft ventricular dysfunction
High arterial pressure
Age 75 years or age 65 - 74 years
Diabetes
History of thrombotic events transient ischemic cerebral attack or stroke venous thromboembolic events
Associated treatment with a proton pomp inhibitor or other gastric protector
Statistical analyses Descriptive characteristics were analyzed with median values their 25-75 interquartile ranges IQR and minimum-maximum values MIN-MAX or mean values with standard deviation SD The Fishers exact test will be performed to compare proportions in contingency tables and the t Student test to compare continuous variables An approximate 95 confidence interval will be determined 95 CI for every statistical analysis and a p-value 005 will be considered statistically significant The GraphPad v70 Prism Software Inc San Diego CA will be used to perform the statistical analyses
Objectives of the KADOAH study are
To compare the risk of bleeding events of 2 types of long-term anticoagulant treatment vitamin K antagonists VKA versus Direct Oral Anticoagulants DOAC in patients with hemophilia
To describe the different types of bleeding events that occur during anticoagulant treatments in patients with hemophilia
To investigate for the influence of the HAS-BLED score on the risk of bleeding events in patients with hemophilia receiving a long-term anticoagulant treatment
Inclusion criteria
Cases
Males at any ages with hemophilia of any severity and of any type
Patients having received or receiving a long-term anticoagulant treatment during at least 6 consecutive months during the period from 2012 to 2021
Regular follow-up in a hemophilia treatment center
Controls cross-matched with cases on
Age - 5 years
Hemophilia type either A or B
Hemophilia severity for mild hemophilia same basal factor level - 5
HAS-BLED score same score - 1
Exclusion criteria
Lost to medical follow-up
Refusal to participate in the study
Unable to understand the studys French letter of non-opposition and information
Collected data
All data collected in this study were issued from the medical files at the moment of the inclusion in the study They include
The age
The hemophilias type
The hemophilias severity and last basal factor VIII or IX level
The treatment with anticoagulant drug for cases including
Type of drug either VKA or DOAC
Duration of treatments
Treatments dosages
Compliance of treatments
Indications
If stopped prematurely reasons for stopping
The occurrence of severe bleeding events SBE following the ISTH definition 7
The number of SBE per patient
The types of SBE
The treatment of SBE
The HAS-BLED score calculated with the presence or absence of the following items
High arterial pressure
Abnormal renal andor liver functions
Hemorrhagic stroke
Bleeding antecedent
Age 65 years
Treatments altering the hemostasis out of the anticoagulants andor alcohol intoxication
The CHA2DS-VASc score calculated with the presence or absence of the following items
Cardiac insufficiencyleft ventricular dysfunction
High arterial pressure
Age 75 years or age 65 - 74 years
Diabetes
History of thrombotic events transient ischemic cerebral attack or stroke venous thromboembolic events
Associated treatment with a proton pomp inhibitor or other gastric protector
Statistical analyses Descriptive characteristics were analyzed with median values their 25-75 interquartile ranges IQR and minimum-maximum values MIN-MAX or mean values with standard deviation SD The Fishers exact test will be performed to compare proportions in contingency tables and the t Student test to compare continuous variables An approximate 95 confidence interval will be determined 95 CI for every statistical analysis and a p-value 005 will be considered statistically significant The GraphPad v70 Prism Software Inc San Diego CA will be used to perform the statistical analyses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None