An interventional study of Transoesophageal echocardiography in Atrial Fibrillation and Stroke, sponsored by The Interuniversity Cardiology Institute of the Netherlands. Completed at 10 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-09-07.
Sponsored by The Interuniversity Cardiology Institute of the Netherlands · Not applicable, Interventional, and Treatment
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.
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
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 227 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →This is the only study on the registry with The Interuniversity Cardiology Institute of the Netherlands as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ascal 100mg once daily
Procedure: Transoesophageal echocardiography
Acenocoumarol or fenprocoumon
Procedure: Transoesophageal echocardiography
TEE
Also known as: No other names
A composite of the following endpoints: ischemic stroke, systemic embolism, major bleeding, acute coronary syndrome, death.
Time frame: at least 1 year
Completion of a technical adequate TTE/TEE on the four echocardiographic features of high stroke risk.
Time frame: 1 year
This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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