Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05195372 |
| Other study ID # |
APSANTICO-Registry |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2015 |
| Est. completion date |
July 2022 |
Study information
| Verified date |
January 2022 |
| Source |
Cardioangiologisches Centrum Bethanien |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Retrospective monocentric registry to evaluate the efficacy and safety of different
anticoagulants in patients with thromboembolic antiphospholipid syndrome
Description:
Antiphospholipid syndrome is a thrombophilic diathesis characterised by the occurrence of
recurrent, unprovoked thromboembolic events (arterial, venous, microvascular) in combination
with the presence of specific APS antibodies.
A distinction is made between different subtypes of APS. One is the thrombotic
antiphospholipid syndrome (APS), which is the focus of the registry, and the other is
obstetric APS, which is characterised by obstetric complications.
The particular challenge in dealing with APS patients is to establish an adequate therapy
regime, as some patients suffer from an increased risk of recurrent thrombosis despite
anticoagulation and/or aggregation inhibition.
The standard medication for antiphospholipid syndrome is based on the use of vitamin K
antagonists (VKA). This regimen is essential to follow, especially in high-risk patients with
positive lupus anticoagulants and/or triple positive antiphospholipid antibodies.
In 2019, a 'Red Hand Letter' was issued advising against treating APS patients with direct
oral anticoagulants (DOACs) but so far some studies suggest that alternative anticoagulation
with DOACs may be beneficial in a selected patient population with a single- or
double-positive antiphospholipid antibody profile.
However, the current data on the use of DOAKs in patients with antiphospholipid syndrome is
still limited. Therefore, the analysis of the patient data available in the investigator's
specialised coagulation centre in the form of the APSantiCO registry should help to select a
suitable anticoagulant regimen in everyday clinical practice.
The clinical and laboratory data required for the creation of the register are already
available for evaluation in the form of electronic medical records, as the Coagulation Centre
of the CCB Bethanien Hospital, which was founded in 2015, has been providing outpatient care
to numerous APS patients for years. The data regarding the recording of recurrent thromboses
despite anticoagulation and major bleeding under the various anticoagulants are collected
with the help of a differentiated study of records. In addition, telephone contact is made
with the patients. The telephone contact takes place within the framework of routine quality
assurance in order to ensure optimal patient care, since many patients were unable or
unwilling to attend their semi-annual or annual routine check-ups in the last two years due
to the COVID 19 pandemic situation.
In the course of the telephone call, it should therefore be clarified whether a new
appointment is needed, e.g. in case of a new event under the existing medication since the
last presentation at the coagulation centre or in case of the occurrence of undesirable side
effects and bleeding.
Apart from this telephone call, no patient contact is foreseen.
