An Investigator-initiated Linked Study to OCEANIC-AF
Recruiting · NCT06124612 · Observational (researchers observe without assigning treatment) · Lead sponsor: East and North Hertfordshire NHS Trust
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Patients aged 18 years or over
- Patients enrolled in OCEANIC-AF study
- Free from the
Exclusion criteria
- below
- The patient is willing and able to understand the Patient Information Sheet and provide written informed consent
- The patient agrees to comply with the drawing of blood samples for the assessments.
- Exclusion Criteria:
- Inability to provide valid informed consent
- Patients aged \< 18 years of age
- Patients with significant neurological, hepatic, renal, endocrine, gastrointestinal, pulmonary, haemorrhagic, metabolic or other disease likely to confound the study requirements or analyses
- Patients with a history of substance abuse or signs or clinical features of active substance abuse or psychiatric disease
- Alcohol consumption above 21 units per week
- Any illness deemed significant by the investigator during the four (4) weeks preceding the screening period of the study
- 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 it is running
2 locations listed.
- Liverpool Heart and Chest Hospital - Liverpool, United Kingdom
- East and North Herts NHS Trust - Stevenage, United Kingdom