Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00224757
Status:
COMPLETED
Last Update Posted:
2011-09-07
First Post:
2005-09-21
Brief Title:
Transesophageal Echocardiography to Identify pAtients With Low Risk of Stroke in Atrial Fibrillation - TIARA Pilot Study
Sponsor:
The Interuniversity Cardiology Institute of the Netherlands
Organization:
The Interuniversity Cardiology Institute of the Netherlands
Study Overview
Official Title:
Transesophageal Echocardiography to Identify pAtients With Low Risk of Stroke in Atrial Fibrillation
Status:
COMPLETED
Status Verified Date:
2011-09
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:
TIARA
Brief Summary:
In this multi centre pilot study we will perform TEE in patients with AF who are eligible for VKA treatment TTE will be used as pre-screening if TTE shows left atrial abnormalities or aortic plaque patients will be excluded from randomisation TEE will be performed in all other patients to detect or exclude complex aorta plaques or signs of left atrial stasis Three hundred patients who do not have these features on TTE will be randomly assigned to treatment with aspirin or VKA Follow-up will be 1 year
Detailed Description:
BACKGROUND Atrial fibrillation AF is an independent risk factor for stroke Therapy with vitamin K antagonists VKA and aspirin reduces the risk of thromboembolism TE dramatically Risk stratification is nowadays based on clinical characteristics However many high risk AF patients may actually be at low risk identified by trans-oesophageal echocardiography TEE
HYPOTHESIS A comprehensive strategy of TEE based aspirin treatment in AF patients eligible for VKA therapy is safe and feasible
OBJECTIVES
1 To show that TEE based aspirin treatment is safe when compared with VKA therapy
2 To test the feasibility of TEE as a tool to detect all four echocardiographic features of high stroke risk
METHODS In this multi centre pilot study we will perform TEE in patients with AF who are eligible for VKA treatment TTE will be used as pre-screening if TTE shows left atrial abnormalities or aortic plaque patients will be excluded from randomisation TEE will be performed in all other patients to detect or exclude complex aorta plaques or signs of left atrial stasis Three hundred patients who do not have these features on TTE will be randomly assigned to treatment with aspirin or VKA Follow-up will be 1 year
EXPECTED RESULTS Application of a new echo-guided antithrombotic strategy as proposed herein is feasible and may help to reduce bleeding whilst stroke prevention is maintained If the lower limit of the 95 confidence interval of the yearly incidence of the primary endpoint on aspirin remains below 44 then a large multi centre randomised controlled trial will be performed
HYPOTHESIS A comprehensive strategy of TEE based aspirin treatment in AF patients eligible for VKA therapy is safe and feasible
OBJECTIVES
1 To show that TEE based aspirin treatment is safe when compared with VKA therapy
2 To test the feasibility of TEE as a tool to detect all four echocardiographic features of high stroke risk
METHODS In this multi centre pilot study we will perform TEE in patients with AF who are eligible for VKA treatment TTE will be used as pre-screening if TTE shows left atrial abnormalities or aortic plaque patients will be excluded from randomisation TEE will be performed in all other patients to detect or exclude complex aorta plaques or signs of left atrial stasis Three hundred patients who do not have these features on TTE will be randomly assigned to treatment with aspirin or VKA Follow-up will be 1 year
EXPECTED RESULTS Application of a new echo-guided antithrombotic strategy as proposed herein is feasible and may help to reduce bleeding whilst stroke prevention is maintained If the lower limit of the 95 confidence interval of the yearly incidence of the primary endpoint on aspirin remains below 44 then a large multi centre randomised controlled trial will be performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None