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Antiphospholipid Syndrome (APS)DOWAPSNCT06884384

DOAC Versus VKA in Patients With Non-high-risk APS : Prospective Cohort Study

An observational study of Antiphospholipid Syndrome (APS) and Cohort Study, run by Central Hospital, Nancy, France at 13 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Additional blood collection during routine blood sampling at the inclusion (33.9 ml) and at the thrombotic recurrence (between 3.5 and 5 ml), Completion of a questionnaire on compliance with anticoagulant treatment and Completion of a questionnaire on satisfaction with treatment anticoagulant
How many people
310 participants
Where
13 sitesFrance
Study dates
15 Sep 2025to 15 Sep 2031
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study 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.

Who may be able to join

  • 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;
  • Carrier of venous thrombotic SAPL:
  • 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
  • Regardless of how long the disease has been present
Show all 14Show fewer
  • With persistent positivity of at least one biological criterion:
  • Positivity of circulating lupus anticoagulant or IgG anticardiolipid or IgG anti-beta-2GPI
  • And persistence of the same positive test ≥ 12 weeks apart
  • And With maximum delay of positivity of the 1st antiphospholipid test of 3 years after the thrombotic event
  • Current anticoagulant treatment, regardless of date of introduction
  • rivaroxaban or apixaban
  • or antivitamin K
  • Patient affiliated to a social security system

Who cannot join

  • Venous thrombotic event motivating current anticoagulant treatment favoured by a major favouring factor:
  • 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.
  • In the absence of a history of pre-eclampsia or placental insufficiency: venous thrombotic event motivating current anticoagulant treatment favoured by 2 or more minor favouring factors:
Show all 25Show fewer
  • Systemic autoimmune disease or active inflammatory bowel disease
  • Acute/severe infection
  • Central venous catheter in the same vascular bed
  • Hormone replacement therapy, estrogenic oral contraceptives, or hormone-stimulating therapy in progress
  • Long-distance travel (≥ 8 hours)
  • Obesity (BMI ≥ 30 kg/m²)
  • Pregnancy or post-partum (6 weeks after delivery)
  • Prolonged immobilization
  • Surgery with general/spinal/epidural anesthesia for < 30 minutes in the 3 months preceding the event
  • Known triple antiphospholipid positivity
  • Isolated IgM antiphospholipid positivity
  • History of known arterial thrombosis
  • History of known microcirculatory thrombosis
  • Known SAPL-related cardiac valvular disease
  • Persons referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code
  • Persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care under articles L. 3212-1 and L. 3213-1.
  • Glomerular filtration rate < 30ml/min.
  • Weight < 50kg
  • History of thrombotic recurrence under well-administered anticoagulant therapy.

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

13 sites in 1 country

France13 sites

  • CHU d'Amiens

    Amiens, 80054

    Simon Soudet, 000000000, Soudet.Simon@chu-amiens.fr

    Simon SOUDET

  • CHU de Besançon

    Besançon, 25030

    Nadine Magy-Bertrand, 00000000, nadine.magy@univ-fcomte.fr

    Nadine MAGY BERTRAND

  • CHU de Brest

    Brest, 29200

    Francis Couturaud, 00000000, francis.couturaud@chu-brest.fr

    Francis COUTURAUD

  • CHU de Dijon

    Dijon, 21079

    Hélène Greigert, MD, 00000000 ext. +33, helene.greigert@chu-dijon.fr

    Hélène GREIGERT

  • CHU de Lyon

    Lyon, 69003

    Thomas Barba, 00000000, thomas.barba@chu-lyon.fr

    Thomas BARBA

  • Hôpital Robert Schuman, UNEOS

    Metz, 57000

    Julien Campagne, 00000000 ext. +33, julien.campagne@uneos.fr

    Julien CAMPAGNE

  • CH de Mulhouse

    Mulhouse, 68100

    Amer Hamade, 00000000, HAMADEA@ghrmsa.fr

    Amer HAMADE

  • CHU de Nantes

    Nantes, 44800

    Olivier Espitia, 00000000, Olivier.ESPITIA@chu-nantes.fr

    Olivier ESPITIA

  • Hôpital Lariboisière - APHP

    Paris, 75010

    Maxime Delrue, 00000000, maxime.delrue@aphp.fr

    Maxime DELRUE

  • CHU de Reims

    Reims, 51100

    Amélie Servettaz, 000000000, aservettaz@chu-reims.fr

    Amélie SERVETTAZ

  • CHU de Saint Etienne

    Saint-Priest-en-Jarez, 42270

    Géraldine Poenou, 00000000, Geraldine.Poenou@chu-st-etienne.fr

    Géraldine POENOU

  • CHU de Strasbourg - Hôpital civil

    Strasbourg, 67091

    Dominique Stephan, 00000000, Dominique.Stephan@chru-strasbourg.fr

    Dominique STEPHAN

  • Central Hospital, Nancy, France

    Vandœuvre-lès-Nancy, Grand Est, 54500

    Virginie DUFROST, MD, 0383157828 ext. +33, v.dufrost@chru-nancy.fr

    Denis WAHL, MD, PhD, d.wahl@chru-nancy.fr

Other trials in France

About this study

Official title: Direct Oral Anticoagulants Versus Warfarin in Patients With Non-high-risk Antiphospholipid Syndrome : Prospective Cohort Study

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.

Read the detailed description

prospective cohort of APS patient treated with VKA or DOACs (specially oral Xa treatment).

APS patients will be non high risk patients (no triple positivity, any previous arterial or small vessels thrombosis or cardiac involvment).

the treatment taken by the patient at inclusion will not be modified. There will therefore be no change to the patient's usual management.

all patients will have a blood sample taken at inclusion as part of a routine blood test.

Patients will be prospectively follow up and the level of recurrence thrombotic event will be recorded

Being tested
Additional blood collection during routine blood sampling at the inclusion (33.9 ml) and at the thrombotic recurrence (between 3.5 and 5 ml), Completion of a questionnaire on compliance with anticoagulant treatment, Completion of a questionnaire on satisfaction with treatment anticoagulant
Keywords
Antiphospholipid Syndrome, VKA treatment, DOAC Treatment, biological analysis, Thrombotic and bleeding events
Medical subject headings
Antiphospholipid Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

    At 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 treatmentBehavioural

    Also called GIRERD questionnaire

    The 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 anticoagulantBehavioural

    Also called Anti-Clot Treatment Scale - ACTS

    The 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.

Study groups in NCT06884384
Study groupRoleWhat they receive
Patient with VKA treatmentPopulation of "non-high-risk" thrombotic APS patients treated with VKAs, regardless of how long they have been on therapy. "Non-high-risk" APS is defined by the absence of a history of arterial or microcirculatory thrombosis, the absence of valvulopathy related to APS and a biological profile with only one or two positive antiphospholipid tests.
Receives: Biological: Additional blood collection during routine blood sampling at the inclusion (33.9 ml) and at the thrombotic recurrence (between 3.5 and 5 ml); Behavioral: Completion of a questionnaire on compliance with anticoagulant treatment; Behavioral: Completion of a questionnaire on satisfaction with treatment anticoagulant
Patient with DOAC treatmentPopulation of "non-high-risk" thrombotic APS patients treated with oral AntiXa, regardless of how long they have been treated. Non-high-risk" APS is defined by the absence of a history of arterial or microcirculatory thrombosis, the absence of valvulopathy related to APS, and a biological profile with only one or two positive antiphospholipid tests.
Receives: Biological: Additional blood collection during routine blood sampling at the inclusion (33.9 ml) and at the thrombotic recurrence (between 3.5 and 5 ml); Behavioral: Completion of a questionnaire on compliance with anticoagulant treatment; Behavioral: Completion of a questionnaire on satisfaction with treatment anticoagulant

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: "From enrollment to the thrombotic recurrence or the end of the study (24 months post-inclusion)

Secondary outcomes (7)

  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.

    Measured: 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

    Measured: 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

    Measured: 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.

    Measured: From enrollment to the end of follow-up (24 months post-inclusion or thrombotic recurrence)

  5. Net clinical benefit defined as a composite endpoint between the 2 arms

    Net clinical benefit defined as a composite endpoint including venous, arterial or microcirculatory thrombotic recurrence, cardiovascular death or major bleeding as defined by ISTH during 24-month follow-up.

    Measured: From enrollment to the end of follow-up (24 months post-inclusion or thrombotic recurrence)

  6. Drug Compliance evaluation between the 2 arms

    Drug Compliance score assessed by Girerd test at baseline and follow-up visits. Score between 0 to 6. 0 indicates a good observance, 1 to 2 : minimal observance problem and ≥ 3 : Poor compliance

    Measured: From enrollment to the end of follow-up (24 months post-inclusion or thrombotic recurrence)

  7. Quality of life under anticoagulants evaluation by Anti-Clot Treatment Scale (ACTS) satisfaction scores between the 2 arms

    Anti-Clot Treatment Scale (ACTS) satisfaction scores measured at inclusion and at follow-up visits.

    The ACTS Burdens total score ranges from 12 to 60, and the ACTS Benefits total score ranges from 3 to 15. A high score for both indicates better quality of life on anticoagulants

    Measured: From enrollment to the end of follow-up (24 months post-inclusion or thrombotic recurrence)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2025
  2. Study start15 Sep 2025 (estimated)
  3. Primary completion15 Sep 2031 (estimated)
  4. Study completion15 Sep 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
310 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06884384
Sponsor's protocol ID
2024-A02295-42
Other IDs
2023-0195
Acronym
DOWAPS
Status last verified
Apr 2025
First submitted
13 Mar 2025
Last updated
13 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Williams B, Saseen JJ, Trujillo T, Palkimas S. Direct oral anticoagulants versus warfarin in patients with single or double antibody-positive antiphospholipid syndrome. J Thromb Thrombolysis. 2022 Jul;54(1):67-73. doi: 10.1007/s11239-021-02587-0. Epub 2021 Nov 24.

    PubMed 34817786

  • Dufrost V, Darnige L, Reshetnyak T, Vorobyeva M, Jiang X, Yan XX, Gerotziafas G, Jing ZC, Elalamy I, Wahl D, Zuily S. New Insights into the Use of Direct Oral Anticoagulants in Non-high Risk Thrombotic APS Patients: Literature Review and Subgroup Analysis from a Meta-analysis. Curr Rheumatol Rep. 2020 May 20;22(7):25. doi: 10.1007/s11926-020-00901-y.

    PubMed 32436109

  • Zuily S, Cohen H, Isenberg D, Woller SC, Crowther M, Dufrost V, Wahl D, Dore CJ, Cuker A, Carrier M, Pengo V, Devreese KMJ. Use of direct oral anticoagulants in patients with thrombotic antiphospholipid syndrome: Guidance from the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. J Thromb Haemost. 2020 Sep;18(9):2126-2137. doi: 10.1111/jth.14935.

    PubMed 32881337

  • Dufrost V, Risse J, Reshetnyak T, Satybaldyeva M, Du Y, Yan XX, Salta S, Gerotziafas G, Jing ZC, Elalamy I, Wahl D, Zuily S. Increased risk of thrombosis in antiphospholipid syndrome patients treated with direct oral anticoagulants. Results from an international patient-level data meta-analysis. Autoimmun Rev. 2018 Oct;17(10):1011-1021. doi: 10.1016/j.autrev.2018.04.009. Epub 2018 Aug 11.

    PubMed 30103045

  • Pengo V, Denas G, Zoppellaro G, Jose SP, Hoxha A, Ruffatti A, Andreoli L, Tincani A, Cenci C, Prisco D, Fierro T, Gresele P, Cafolla A, De Micheli V, Ghirarduzzi A, Tosetto A, Falanga A, Martinelli I, Testa S, Barcellona D, Gerosa M, Banzato A. Rivaroxaban vs warfarin in high-risk patients with antiphospholipid syndrome. Blood. 2018 Sep 27;132(13):1365-1371. doi: 10.1182/blood-2018-04-848333. Epub 2018 Jul 12.

    PubMed 30002145

Questions about this trial

What is this clinical trial studying?

An observational study of Antiphospholipid Syndrome (APS) and Cohort Study, run by Central Hospital, Nancy, France at 13 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of thrombotic recurrence between the 2 arms (time frame: "From enrollment to the thrombotic recurrence or the end of the study (24 months post-inclusion)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06884384, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.

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