NCT06124612 An Investigator-initiated Linked Study to OCEANIC-AF
| NCT ID | NCT06124612 |
| Status | Recruiting |
| Phase | — |
| Sponsor | East and North Hertfordshire NHS Trust |
| Condition | Atrial Fibrillation |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-11-03 |
| Primary Completion | 2026-09-17 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2023-11-03 with a primary completion date of 2026-09-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Impaired endogenous fibrinolysis is a recently recognised risk factor for thrombotic events in patients with cardiovascular disease. Enhancing endogenous fibrinolysis in such individuals represents a way of reducing thrombosis risk. However, the optimal pharmacotherapy to enhance fibrinolysis is unclear. The aim of this study is to assess the effect of asundexian on endogenous fibrinolysis and compare this to apixaban. If asundexian can enhance endogenous fibrinolysis, this could be used as targeted treatment for patients who despite optimal antithrombotic therapy, demonstrate impaired endogenous fibrinolysis.
Eligibility 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)
Contact & Investigator
Diana A Gorog, MD, PhD
PRINCIPAL INVESTIGATOR
East and North Hertfordshire NHS Trust
Frequently Asked Questions
Who can join the NCT06124612 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06124612 currently recruiting?
Yes, NCT06124612 is actively recruiting participants. Contact the research team at joshua.leader@nhs.net for enrollment information.
Where is the NCT06124612 trial being conducted?
This trial is being conducted at Liverpool, United Kingdom, Stevenage, United Kingdom.
Who is sponsoring the NCT06124612 clinical trial?
NCT06124612 is sponsored by East and North Hertfordshire NHS Trust. The principal investigator is Diana A Gorog, MD, PhD at East and North Hertfordshire NHS Trust. The trial plans to enroll 100 participants.
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