Assessing the effects of asundexian on blood clot lysis in patients with atrial fibrillation
Assessing the Effect of Asundexian on Thrombotic Status, in Particular Endogenous Fibrinolysis, in Patients With Atrial Fibrillation
This study is testing if asundexian helps patients with atrial fibrillation dissolve blood clots better than apixaban to lower their risk of heart attacks and strokes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | East and North Hertfordshire NHS Trust Government |
| Locations | 2 sites (Liverpool and 1 other locations) |
| Trial ID | NCT06124612 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the impact of asundexian on endogenous fibrinolysis in patients with atrial fibrillation, comparing its effects to those of apixaban. By utilizing advanced blood testing techniques, the study seeks to determine how well these medications enhance the body's natural ability to dissolve clots, which is crucial for reducing the risk of heart attacks and strokes. Participants will be drawn from those already enrolled in the OCEANIC-AF study, and additional blood samples will be collected for analysis. The findings could lead to targeted treatments for patients who are at high risk despite current antithrombotic therapies.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 18 and over who are already enrolled in the OCEANIC-AF study and can provide informed consent.
Not a fit: Patients with significant comorbidities or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new targeted treatment option for patients with impaired clot lysis, potentially reducing their risk of thrombotic events.
How similar studies have performed: While the approach of enhancing endogenous fibrinolysis is relatively novel, previous studies have shown that anticoagulants like apixaban can mildly improve clot lysis, indicating potential for success with asundexian.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged 18 years or over 2. Patients enrolled in OCEANIC-AF study 3. Free from the exclusion criteria below 4. The patient is willing and able to understand the Patient Information Sheet and provide written informed consent 5. The patient agrees to comply with the drawing of blood samples for the assessments. Exclusion Criteria: 1. Inability to provide valid informed consent 2. Patients aged \< 18 years of age 3. Patients with significant neurological, hepatic, renal, endocrine, gastrointestinal, pulmonary, haemorrhagic, metabolic or other disease likely to confound the study requirements or analyses 4. Patients with a history of substance abuse or signs or clinical features of active substance abuse or psychiatric disease 5. Alcohol consumption above 21 units per week 6. Any illness deemed significant by the investigator during the four (4) weeks preceding the screening period of the study 7. Any major bleeding diathesis or blood dyscrasia (platelets \<70 x 109/l, Hb \<80 g/dl, INR \>1.4, APTT \>x 2 UNL, leucocyte count \<3.5 x 109/l, neutrophil count \<1 x 109/l)
Where this trial is running
Liverpool and 1 other locations
- Liverpool Heart and Chest Hospital — Liverpool, United Kingdom (Not_yet_recruiting)
- East and North Herts NHS Trust — Stevenage, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Diana A Gorog, MD, PhD — East and North Hertfordshire NHS Trust
- Study coordinator: Joshua H Leader, MBCHB, BSc
- Email: joshua.leader@nhs.net
- Phone: 07376188768
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.