DOAC Versus VKA in Patients With Non-high-risk APS : Prospective Cohort Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentral Hospital, Nancy, France
About this trial
Antiphospholipid syndrome (APS) is a thrombotic disease requiring prolonged anticoagulation. Direct oral anticoagulants (DOACs) are indicated as 1st-line therapy in venous thrombosis, compared with VKAs, due to their easier handling and lower bleeding risk for equivalent efficacy. In APS, VKAs are still the reference treatment. However, DOACs are generally introduced in the acute phase of venous, before the diagnosis of APS. VKA have the disadvantage of numerous food and drug interactions, and therefore require close monitoring of INR, at least once a month. Because they are easier to use than VKAs, and the risk of bleeding is lower, patients are often reluctant to switch from DOACs to VKA. Studies have shown that APS patients with high thrombotic risk (positivity of all three antiphospholipid tests, history of arterial or small vessels thrombosis or cardiac valve damage) have an increased thrombotic risk during DOACs vs. VKA treatment. Since 2020, the ISTH guidelines have suggested avoiding DOACs in high-risk APS, but suggest continuing theim in other patients if they were introduced for venous thrombosis and if follow-up on DOACs is reassuring. In the case of high-risk APS patients, the relay is therefore systematic. For non-high-risk patients (the majority), there are no data to justify systematic switch. Given the quality-of-life advantages of DOACs over VKAs, patients are not always in favor of changing their anticoagulant therapy, especially if they have been on it for many years with good tolerability. For these reasons, a number of patients with non-high-risk APS remain on DOACs. Nevertheless, the limited data available on the efficacy of DOACs in non-high-risk patients are of low level of evidence and contradictory. In 2020, a literature review of non-high-risk SAPL patients treated with DOACs reported that 8.6% of them experienced thrombotic recurrence within 12 months, with no possible comparison with VKAs. A recent retrospective study with 96 patients reported that 15.4% of patients treated with DOACs had a recurrence, compared to 5.3% on VKAs. However, this difference was not statistically significant (p=0.15) due to a clear lack of power. The objective is to determine the frequency of thrombotic recurrences and to compare it according to the type of oral treatment, anti-Xa versus VKA, in non-high-risk APS, through a cohort study with prospective follow-up. The patient's usual antithrombotic treatment, DOAC and VKA, will be continued unchanged.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Persons who have received full information about the organization of the research and have given their oral consent to participate.
Male or female 18 years of age or older;
Not favoured by a major or ≥ 2 minor favouring factors, if the patient doesn't present with obstetrical SAPL in accordance with the ACR/EULAR 2023 clinical classification criteria.
Or favored by ≥ 2 minors, if the patient has obstetrical SAPL: severe preeclampsia < 34 weeks or placental insufficiency
Disqualifiers
Active cancer
Hospitalization with bed rest for at least 3 days in the 3 months preceding the event
Major trauma with fractures or spinal cord injury in the month preceding the event
Surgery with general/spinal/epidural anesthesia for > 30 minutes in the 3 months preceding the event.
Trial population
Population of "non-high-risk" thrombotic APS patients treated with oral AntiXa or VKA regarding the treatment already taken at inclusion. Non-high-risk" APS is defined by no history of arterial or small vessels thrombosis, any valvulopathy related to APS, and a biological profile with only one or two positive antiphospholipid tests. Patients will be recruited via the departments authorized to manage them, during their consultation or hospitalization. Patients will be invited to participate in the study as part of their regular follow-up visit. There will be no change in current antithrombotic treatment at the time of inclusion.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Additional blood collection during routine blood sampling at the inclusion (33.9 ml) and at the thrombotic recurrence (between 3.5 and 5 ml)
Biological/VaccineAt inclusion, the blood sample is used to perform thrombin generation tests (activated protein C resistance profile and ratio), classical and innovative aPL assays centrally to limit the fluctuation inherent in the tests used and enable comparison between patients, immunothrombosis markers: circulating neutrophil extracellular traps (NETs) assay, sTREM-1 assay In the event of recurrence, blood sampling can be used to confirm compliance with treatment by measuring the anti Xa activity of the drug or INR
Completion of a questionnaire on compliance with anticoagulant treatment
BehavioralThe Girerd questionnaire (6 questions) will be proposed to patients in order to estimate the degree of compliance with AODs and VKAs at inclusion and at each follow-up visit for the duration of their participation in the study.
Completion of a questionnaire on satisfaction with treatment anticoagulant
BehavioralThe ACTS questionnaire (15 questions) will be proposed to them in order to estimate their satisfaction with their anticoagulant treatment (AOD or AVK) at inclusion and at each follow-up visit for the duration of their participation in the study.
Treatment groups
310 Participants
are divided into 2 treatment groupsGroup A: Patient with VKA treatment3 interventions
Group B: Patient with DOAC treatment3 interventions
Trial outcomes
Primary outcomes
1
Frequency of thrombotic recurrence between the 2 arms
Occurrence (percentage at group level) of thrombotic recurrence within 24 months of inclusion confirmed by objective examination and defined by the occurrence of one of the following events: * Venous thrombosis of any location or pulmonary embolism * Arterial thrombosis in any location * Microcirculatory thrombosis in any location
Time frame
"From enrollment to the thrombotic recurrence or the end of the study (24 months post-inclusion)Secondary outcomes
1
Risk Factors of thrombotic recurrence on the 2 arms
The risk factors for thrombotic recurrence tested were: age, gender, cardiovascular risk factors, manifestations associated with APS, associated autoimmune diseases, biological parameters (antiXa activity, INR, biomarkers of immunothrombosis collected as part of the research.
Time frame
Biological parameters : at the end of the study after the last visit of the last patient. No biological parameters : from enrollment to the end of follow-up (24 months post-inclusion or thrombotic recurrence)2
Occurrence of major hemorrhage between the 2 arms
Major bleeding as defined by the International Society on Thrombosis and Haemostasis within Haemostasis within 24 months of inclusion
Time frame
From enrollment to the end of follow-up (24 month post-inclusion or thrombotic recurrence)3
Occurrence of clinically relevant hemorrhage between the 2 arms
Occurrence of clinically relevant bleeding as defined by the International Society on Thrombosis and Haemostasis within 24 months of inclusion
Time frame
From enrollment to the end of follow-up (24 months post-inclusion or thrombotic recurrence)4
Occurrence of a minor bleed between the 2 arms
Occurrence of a minor bleed within 24 months of inclusion, defined as a bleed that does not meet the International Society on Thrombosis and Haemostasis definition of clinically relevant major or non-major bleeding.
Time frame
From enrollment to the end of follow-up (24 months post-inclusion or thrombotic recurrence)Sponsors and contacts
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Source ClinicalTrials.gov
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