Antiphospholipid SyndromeOBSTINATENCT04262492
International Registry of Thrombotic APS Patients Treated With Direct Oral Anticoagulants
An observational study of Antiphospholipid Syndrome and Thrombosis, run by Stéphane Zuily at 1 site in France.
Trial summary
This registry, currently being established will ensure consistency of data collection and provide safety information in non high-risk APS patients currently on DOACs. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Antiphospholipid Syndrome, Thrombosis, Anticoagulants Causing Adverse Effects in Therapeutic Use
- What is being tested?
- Rivaroxaban
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 21 Oct 2020to 21 Apr 2031
- How long will I take part?
- 5 Years
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Thrombotic APS patients according to revised Sapporo-Sydney criteria
Who may be able to join
- Patient receiving a comprehensive information about the study, and not opposed to participate
- Age ≥ 18 yo
- Classification of definite APS according to revised Sapporo-Sydney criteria
- Direct oral anticoagulant treatment prescribed during at least 6 months or with the possibility of follow-up of at least 6 months
Who cannot join
- Incomplete revised Sapporo-Sydney criteria
- No data regarding the recurrent thrombosis
- Pregnant woman
- Age < 18 yo
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Stéphane Zuily
Nancy, 54500
Stéphane Zuily, MD, PhD, +33383157354, s.zuily@chru-nancy.fr
Virginie Dufrost, MD, MSc
About this study
Official title: OBServaToire INternational Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs
This registry, currently being established will ensure consistency of data collection and provide safety information in non high-risk APS patients currently on DOACs.
- Conditions
- Antiphospholipid Syndrome, Thrombosis, Anticoagulants Causing Adverse Effects in Therapeutic Use
- Being tested
- Rivaroxaban
- Keywords
- antiphospholipid syndrome, direct oral anticoagulants
- Medical subject headings
- Antiphospholipid Syndrome, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Also called Dabigatran, Apixaban, Edoxaban
Rivaroxaban 10 mg or 15 mg or 20 mg OD Dabigatran 110 mg or 150 mg BID Apixaban 2.5 mg or 5 mg or 10 mg BID
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Recurrent Thrombosis
Rate of Recurrent Thrombosis either arterial, venous or microvascular confirmed by a relevant exam
Measured: 6 months
Secondary outcomes (3)
Rate of Bleeding
Rate of Bleeding either severe or major or clinically relevant non-major bleeding according to ISTH classification
Measured: 6 months
Rate of Non-Criteria Manifestations
Rate of Non-Criteria Manifestations according to Sydney criteria
Measured: 6 months
Adherence to treatment
Rate of patients who have a good adherence to oral anticoagulants assessed by the Girerd questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start21 Oct 2020
- Primary completion21 Apr 2030 (estimated)
- Study completion21 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Antiphospholipid SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Stéphane Zuily
- Sponsor type
- University, hospital or other
- Collaborators
- International Society on Thrombosis and Haemostasis
- Responsible party
- Sponsor-investigator, Stéphane Zuily, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262492
- Sponsor's protocol ID
- 2019-A01415-52
- Acronym
- OBSTINATE
- Status last verified
- May 2026
- First submitted
- 6 Feb 2020
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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 30103045Dufrost V, Risse J, Wahl D, Zuily S. Direct Oral Anticoagulants Use in Antiphospholipid Syndrome: Are These Drugs an Effective and Safe Alternative to Warfarin? A Systematic Review of the Literature: Response to Comment. Curr Rheumatol Rep. 2017 Aug;19(8):52. doi: 10.1007/s11926-017-0676-2. No abstract available.
PubMed 28741234
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OBServaToire INternational Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs
- ClinicalTrials.gov ID
- NCT04262492
- Acronym / sponsor ID
- OBSTINATE / 2019-A01415-52
- Conditions
- Antiphospholipid Syndrome, Thrombosis, Anticoagulants Causing Adverse Effects in Therapeutic Use
- Keywords
- antiphospholipid syndrome, direct oral anticoagulants
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Stéphane ZuilyUniversity, hospital or other
- Collaborators
- International Society on Thrombosis and Haemostasis
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 21 Apr 2030 (estimated)
- Study completion
- 21 Apr 2031 (estimated)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This registry, currently being established will ensure consistency of data collection and provide safety information in non high-risk APS patients currently on DOACs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Thrombotic APS patients according to revised Sapporo-Sydney criteria
Key inclusion criteria (4 listed)
- Patient receiving a comprehensive information about the study, and not opposed to participate
- Age ≥ 18 yo
- Classification of definite APS according to revised Sapporo-Sydney criteria
- Direct oral anticoagulant treatment prescribed during at least 6 months or with the possibility of follow-up of at least 6 months
Key exclusion criteria (4 listed)
- Incomplete revised Sapporo-Sydney criteria
- No data regarding the recurrent thrombosis
- Pregnant woman
- Age < 18 yo
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RivaroxabanAlso: Dabigatran, Apixaban, EdoxabanRivaroxaban 10 mg or 15 mg or 20 mg OD Dabigatran 110 mg or 150 mg BID Apixaban 2.5 mg or 5 mg or 10 mg BID | Drug | – |
Primary outcome
Rate of Recurrent Thrombosis
Time frame: 6 months
Rate of Recurrent Thrombosis either arterial, venous or microvascular confirmed by a relevant exam
3 secondary outcomes
Rate of Bleeding
Time frame: 6 months
Rate of Non-Criteria Manifestations
Time frame: 6 months
Adherence to treatment
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Background: PubMed 30103045Dufrost 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.
- Background: PubMed 28741234Dufrost V, Risse J, Wahl D, Zuily S. Direct Oral Anticoagulants Use in Antiphospholipid Syndrome: Are These Drugs an Effective and Safe Alternative to Warfarin? A Systematic Review of the Literature: Response to Comment. Curr Rheumatol Rep. 2017 Aug;19(8):52. doi: 10.1007/s11926-017-0676-2. No abstract available.
- ISTH SSC LA/aPL projectLink provided by the sponsor.
- OBSTINATE webpageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antiphospholipid Syndrome and Thrombosis, run by Stéphane Zuily at 1 site 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Virginie Dufrost, MD, MSc (+33383157828, v.dufrost@chru-nancy.Fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Recurrent Thrombosis (time frame: 6 months). 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 NCT04262492, which also lists 2 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 8 May 2026.