Transesophageal Echocardiography to Identify pAtients With Low Risk of Stroke in Atrial Fibrillation - TIARA Pilot Study

Stroke Clinical Trial

— TIARA  

Official title:

Transesophageal Echocardiography to Identify pAtients With Low Risk of Stroke in Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00224757
• Other study ID #: 0415
• Status: Completed
• Phase: N/A
• First received: September 21, 2005
• Last updated: September 5, 2011
• Start date: September 2005
• Est. completion date: September 2009

Study information

• Verified date: September 2011
• Source: The Interuniversity Cardiology Institute of the Netherlands
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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 4.4% then a large multi centre randomised controlled trial will be performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Documented atrial fibrillation or atrial flutter, paroxysmal or permanent

• Conventional indication for VKA treatment

• Signed informed consent

Exclusion Criteria:

• Planned electro cardioversion

• Very high risk of TE (previous ischemic stroke or systemic TE, symptoms of heart failure or left ventricular dysfunction, mitral valve stenosis, hypertrophic cardiomyopathy)

• Indication for VKA treatment other than atrial fibrillation (e.g. mechanic valve prosthesis)

• Atrial fibrillation secondary to reversible diseases (e.g. thyrotoxicosis)

• Contraindication for treatment with VKA, aspirin, or clopidogrel

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Intervention

Procedure:
• Transoesophageal echocardiography
TEE

Locations

Country	Name	City	State
Netherlands	Twenteborg	Almelo
Netherlands	VUMC	Amsterdam
Netherlands	Rijnstate Ziekenhuis	Arnhem
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Jeroen Bosch Ziekenhuis	Den Bosch
Netherlands	Atrium Medisch Centrum Heerlen	Heerlen
Netherlands	Academisch Ziekenhuis Maastricht	Maastricht
Netherlands	Diaconessenhuis Meppel	Meppel
Netherlands	UMCN	Nijmegen
Netherlands	Viecuri	Venlo

Sponsors (1)

Lead Sponsor	Collaborator
The Interuniversity Cardiology Institute of the Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A composite of the following endpoints: ischemic stroke, systemic embolism, major bleeding, acute coronary syndrome, death.		at least 1 year	Yes
Secondary	Completion of a technical adequate TTE/TEE on the four echocardiographic features of high stroke risk.		1 year	Yes