Trial · NCT06884384
DOAC Versus VKA in Patients With Non-high-risk APS : Prospective Cohort Study
NCT06884384, Not yet recruiting, Central Hospital, Nancy, France
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. DOAC Versus VKA in Patients With Non-high-risk APS : Prospective Cohort Study. Trials, record NCT06884384. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06884384
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- DOAC Versus VKA in Patients With Non-high-risk APS : Prospective Cohort Study
- NCT number
- NCT06884384
- Status
- Not yet recruiting
- Enrollment
- 310 participants, estimated
- Lead sponsor
- Central Hospital, Nancy, France
- Conditions
- Antiphospholipid Syndrome (APS), Cohort Study, Thrombotic and Bleeding Events
- Interventions
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
- First posted
- 2025-03-19
- Last updated
- 2025-06-13
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Frequency of thrombotic recurrence between the 2 arms | "From enrollment to the thrombotic recurrence or the end of the study (24 months post-inclusion) | 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 |
| Secondary | Risk Factors of thrombotic recurrence on the 2 arms | 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) | 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. |
| Secondary | Occurrence of major hemorrhage between the 2 arms | From enrollment to the end of follow-up (24 month post-inclusion or thrombotic recurrence) | Major bleeding as defined by the International Society on Thrombosis and Haemostasis within Haemostasis within 24 months of inclusion |
| Secondary | Occurrence of clinically relevant hemorrhage between the 2 arms | From enrollment to the end of follow-up (24 months post-inclusion or thrombotic recurrence) | Occurrence of clinically relevant bleeding as defined by the International Society on Thrombosis and Haemostasis within 24 months of inclusion |
| Secondary | Occurrence of a minor bleed between the 2 arms | From enrollment to the end of follow-up (24 months post-inclusion or thrombotic recurrence) | 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. |
| Secondary | Net clinical benefit defined as a composite endpoint between the 2 arms | From enrollment to the end of follow-up (24 months post-inclusion or thrombotic recurrence) | 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. |
| Secondary | Drug Compliance evaluation between the 2 arms | From enrollment to the end of follow-up (24 months post-inclusion or thrombotic recurrence) | 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 |
| Secondary | Quality of life under anticoagulants evaluation by Anti-Clot Treatment Scale (ACTS) satisfaction scores between the 2 arms | From enrollment to the end of follow-up (24 months post-inclusion or thrombotic recurrence) | 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 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06884384
GET https://conductscience.org/api/trials/v1/NCT06884384/registered