Ignite Creation Date:
2024-05-06 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06124612
Status:
RECRUITING
Last Update Posted:
2023-11-09
First Post:
2023-11-05
Brief Title:
An Investigator-initiated Linked Study to OCEANIC-AF
Sponsor:
East and North Hertfordshire NHS Trust
Organization:
East and North Hertfordshire NHS Trust
Study Overview
Official Title:
Assessing the Effect of Asundexian on Thrombotic Status in Particular Endogenous Fibrinolysis in Patients With Atrial Fibrillation
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
The risk of a clot forming in a blood vessel which can cause a heart attack or stroke is determined partly by how sticky the blood is and partly by the effectiveness of the natural defences in the blood in dissolving any clots that start forming clot lysis or fibrinolysis There are available tests that can assess how sticky the blood is and we can overcome that with specific blood-thinning medications such as anticoagulants such as warfarin apixaban rivaroxaban and antiplatelet agents such as aspirin and clopidogrel However we have not been able to assess the effectiveness of natural clot dissolving mechanisms until recently
In the last few years using new blood testing techniques we and other groups have shown that individuals who have less effective natural clot lysis have a much higher risk of heart attack stroke and death Therefore we would like to find medications that can make clot lysis more effective in such individuals to reduce their risk of stroke and heart attack Unfortunately most blood thinning tablets for long term use do not improve clot lysis
Earlier our group has shown that the anticoagulant apixaban mildly improved clot lysis
We would now like to assess clot lysis in patients taking apixaban and compare it to patients taking a very new type of anticoagulant called asundexian to see if asundexian can improve clot lysis more than apixaban
The easiest way to do this is to test additional blood samples from patients who are already taking part in a clinical trial comparing apixaban and asundexian OCEANIC-AF OCEANIC-AF is a phase 3 multicentre randomised clinical trial comparing asundexian a new type of blood thinner factor XI inhibitor with a commonly used blood thinner apixaban a factor X inhibitor to see if it carries a lower risk of bleeding
This is a prospective observational linked study to the main OCEANIC-AF study to be undertaken in 2 centres in England Patients enrolled in OCEANIC-AF at these 2 centres will have 4 additional blood samples taken at baseline before starting the investigational drug or comparator then at the 3 6 and 12 month visits
In the last few years using new blood testing techniques we and other groups have shown that individuals who have less effective natural clot lysis have a much higher risk of heart attack stroke and death Therefore we would like to find medications that can make clot lysis more effective in such individuals to reduce their risk of stroke and heart attack Unfortunately most blood thinning tablets for long term use do not improve clot lysis
Earlier our group has shown that the anticoagulant apixaban mildly improved clot lysis
We would now like to assess clot lysis in patients taking apixaban and compare it to patients taking a very new type of anticoagulant called asundexian to see if asundexian can improve clot lysis more than apixaban
The easiest way to do this is to test additional blood samples from patients who are already taking part in a clinical trial comparing apixaban and asundexian OCEANIC-AF OCEANIC-AF is a phase 3 multicentre randomised clinical trial comparing asundexian a new type of blood thinner factor XI inhibitor with a commonly used blood thinner apixaban a factor X inhibitor to see if it carries a lower risk of bleeding
This is a prospective observational linked study to the main OCEANIC-AF study to be undertaken in 2 centres in England Patients enrolled in OCEANIC-AF at these 2 centres will have 4 additional blood samples taken at baseline before starting the investigational drug or comparator then at the 3 6 and 12 month visits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None