NCT06124612

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Nov 2023

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Nov 2023Sep 2026

Study Start

First participant enrolled

November 3, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 9, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2026

Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

2.9 years

First QC Date

November 5, 2023

Last Update Submit

November 5, 2023

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationEndogenous fibrinolysisGlobal thrombosis test

Outcome Measures

Primary Outcomes (1)

  • Thrombotic status

    The main marker of interest is endogenous fibrinolysis time (LT)

    12 months

Study Arms (1)

Atrial fibrillation

Patients already enrolled in main OCEANIC-AF study.

Diagnostic Test: Thrombotic assessment

Interventions

Thrombotic assessmentDIAGNOSTIC_TEST

GTT The Global Thrombosis Test (GTT) (Thromboquest Limited, UK) is an in vitro method imitating high shear stress conditions akin to that which exist in a severely stenosed artery. The test measures platelet reactivity (occlusion time) and endogenous fibrinolysis time (lysis time). TEG Thromboelastography (TEG, Haemonetics Corporation, USA) is a technique that assesses the whole process of clotting and its viscoelastic properties, from the initial activation and aggregation of platelets, to the role of thrombin and finally the stability of the formed clot, as a measure of fibrinolytic resistance. Citrated plasma will be stored for subsequent evaluation of thrombosis and fibrinolysis markers (including but not restricted to D-dimer, PAI-1, hs-CRP, NETs)

Atrial fibrillation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients enrolled into OCEANIC-AF study at these two centres will be approached to also participate in this linked study.

You may qualify if:

  • Patients aged 18 years or over
  • Patients enrolled in OCEANIC-AF study

You may not qualify if:

  • 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.
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Liverpool Heart and Chest Hospital

Liverpool, United Kingdom

NOT YET RECRUITING

East and North Herts NHS Trust

Stevenage, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Diana A Gorog, MD, PhD

    East and North Hertfordshire NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua H Leader, MBCHB, BSc

CONTACT

07376188768joshua.leader@nhs.net

Diana A Gorog, MD, PhD

CONTACT

01707247512d.gorog@imperial.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 5, 2023

First Posted

November 9, 2023

Study Start

November 3, 2023

Primary Completion (Estimated)

September 17, 2026

Study Completion (Estimated)

September 17, 2026

Last Updated

November 9, 2023

Record last verified: 2023-11

Locations

GB(2)