Investigating anti-platelet factor 4 antibodies in patients with thrombosis
The APIT Study: Prospective Observational Study of the Incidence of Anti-platelet Factor 4 Antibodies in Suspected Immune-associated Arterial and/or Venous Thrombosis
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Cardioangiologisches Centrum Bethanien Academic / other |
| Locations | 2 sites (Berlin and 1 other locations) |
| Trial ID | NCT06650826 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 60 years with spontaneous or infection- or vaccine-associated arterial and/or venous thrombosis.
Not a fit: Patients with thrombosis related to known risk factors such as surgery or chronic vascular conditions may not benefit from this study.
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 performed: While the investigation of anti-platelet factor 4 antibodies is a recognized area of interest, this specific observational approach is relatively novel.
Eligibility criteria
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 this trial is running
Berlin and 1 other locations
- Deutsches Herzzentrum der Charite (DHZC) — Berlin, Germany (Not_yet_recruiting)
- Cardioangiologisches Zentrum Bethanien (CCB) — Frankfurt am Main, Germany (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.