NCT05195372

Brief Summary

Retrospective monocentric registry to evaluate the efficacy and safety of different anticoagulants in patients with thromboembolic antiphospholipid syndrome

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

February 8, 2023

Status Verified

January 1, 2022

Enrollment Period

7.3 years

First QC Date

December 30, 2021

Last Update Submit

February 7, 2023

Conditions

Antiphospholipid SyndromeVenous ThromboembolismArterial ThromboembolismMajor Bleed

Keywords

direct oral anticoagulantvitamin k antagonistantiphospholipid syndromethrombosismajor bleeding

Outcome Measures

Primary Outcomes (1)

  • Recurrent thromboembolism despite coagulation inhibition

    The main observational variable is the occurrence of recurrent thromboembolic events under DOAC-treatment compared to VKA-treatment and/or other therapeutic regimens (e.g. low molecular weight heparins, aggregation inhibitors) in patients with different APS risk profiles.

    2015 - 2021

Secondary Outcomes (1)

  • major bleeding during coagulation inhibition

    2015 - 2021

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive patients with confirmed thromboembolic antiphospholipid-syndrome who need anticoagulation and/or aggregation inhibition

You may qualify if:

  • Minimum age of 18 years
  • Confirmed antiphospholipid syndrome with thromboembolic clinical manifestations (VTE, LAE, stroke etc.)
  • Patients with APS antibody risk profile (single/double/triple positivity)

You may not qualify if:

  • APS with isolated pregnancy complications
  • No coagulation inhibition
  • Inadequately diagnosed APS
  • Non-compliance of patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edelgard Lindhoff-Last

Frankfurt am Main, Hesse, 60389, Germany

Location

MeSH Terms

Conditions

Antiphospholipid SyndromeVenous ThromboembolismThrombosis

Condition Hierarchy (Ancestors)

Autoimmune DiseasesImmune System DiseasesThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Edelgard Lindhoff-Last

    CardioAngiology Center Bethanienhospital (CCB)Frankfurt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2021

First Posted

January 19, 2022

Study Start

January 1, 2015

Primary Completion

April 1, 2022

Study Completion

July 1, 2022

Last Updated

February 8, 2023

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)