Clinical trial NCT00224757: Transesophageal Echocardiography to Identify pAtients With Low Risk of Stroke in Atrial Fibrillation - TIARA Pilot Study
Official title: Transesophageal Echocardiography to Identify pAtients With Low Risk of Stroke in Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Stroke
Keywords: Echocardiography
Lead sponsor: The Interuniversity Cardiology Institute of the Netherlands
Sponsor class: OTHER_GOV
First posted: 2005-09-23
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: A composite of the following endpoints: ischemic stroke, systemic embolism, major bleeding, acute coronary syndrome, death.
timeFrame: at least 1 year
Secondary outcomes:
measure: Completion of a technical adequate TTE/TEE on the four echocardiographic features of high stroke risk.
timeFrame: 1 year
Other outcomes:
Locations:
city: Almelo
country: Netherlands
facility: Twenteborg
city: Amsterdam
country: Netherlands
facility: VUMC
city: Arnhem
country: Netherlands
facility: Rijnstate Ziekenhuis
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Heerlen
country: Netherlands
facility: Atrium Medisch Centrum Heerlen
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht
city: Meppel
country: Netherlands
facility: Diaconessenhuis Meppel
city: Nijmegen
country: Netherlands
facility: UMCN
city: Venlo
country: Netherlands
facility: Viecuri
Study officials:
affiliation: Academisch Ziekenhuis Maastricht
name: HJGM Crijns, MD, PhD
role: STUDY_CHAIR
References: