Investigating anti-platelet factor 4 antibodies in patients with thrombosis
Official title: The APIT Study: Prospective Observational Study of the Incidence of Anti-platelet Factor 4 Antibodies in Suspected Immune-associated Arterial and/or Venous Thrombosis
Run by Cardioangiologisches Centrum Bethanien · NCT06650826 · Data updated 2026-11-12
This study is trying to see if certain antibodies are present in adults aged 18 to 60 who have had blood clots, even after being treated with blood thinners.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Cardioangiologisches Centrum Bethanien Academic / other |
| Locations | 2 sites (Berlin and 1 other locations) |
| Status | Recruiting |
| Started | July 1, 2024 |
| Main results expected | July 2026 |
| Study ends | January 2027 |
| Registry record updated | October 21, 2024 |
| Trial ID | NCT06650826 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 18 to 60 years with spontaneous or infection- or vaccine-associated arterial and/or venous thrombosis.
✕Probably not a fit
Patients with thrombosis related to known risk factors such as surgery or chronic vascular conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to investigate the incidence of anti-platelet factor 4 antibodies in patients aged 18 to 60 years who have experienced spontaneous or infection- or vaccine-associated arterial and/or venous thrombosis. Participants will have blood samples taken within 120 days of their thrombosis event to assess the presence of these antibodies. Additionally, the study will collect data on platelet counts, D-dimer levels, and results from thrombophilia screenings to better understand the relationship between these factors and thrombosis. The study includes patients with recurrent thrombosis despite anticoagulation treatment.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of thrombosis in patients with anti-platelet factor 4 antibodies.
How similar studies have gone: While the investigation of anti-platelet factor 4 antibodies is a recognized area of interest, this specific observational approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18-60 years * Written informed consent of the patient * Spontaneous arterial and/or venous thrombosis * infection-associated arterial and/or venous thrombosis within 30 days of infection * Vaccine-associated arterial and/or venous thrombosis within 30 days of vaccination * Recurrent arterial or venous thrombosis despite anticoagulant therapy Exclusion Criteria: * Lack of consent of the patient * Risk-associated venous thromboses (e.g. following surgery, immobilization, plaster cast, fractures or sprains) * Risk-associated arterial thromboses (in the presence of vascular risk factors such e.g. diabetes mellitus, hypercholesterolemia, hypertension, nicotine abuse) * Thromboses more than 120 days old at the time of blood sampling
Where it's running
-
Cardioangiologisches Zentrum Bethanien (CCB)
Frankfurt am Main, Germany Recruiting -
Deutsches Herzzentrum der Charite (DHZC)
Berlin, Germany Not yet recruiting
Study contacts
- Principal investigator: Edelgard Lindhoff-Last, Professor — Cardioangiologisches Zentrum Bethanien
- Study coordinator: Edelgard Lindhoff-Last, Professor
- Email: e.lindhoff-last@ccb.de
- Phone: +49-699450280
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.