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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Atrial Fibrillation
• Intervention / Treatment: Procedure: Transoesophageal echocardiography

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.

• Study Type: Interventional
• Enrollment (Actual): 227
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Almelo, Netherlands
    • Twenteborg
  • Amsterdam, Netherlands
    • VUMC
  • Arnhem, Netherlands
    • Rijnstate Ziekenhuis
  • Breda, Netherlands
    • Amphia ziekenhuis
  • Den Bosch, Netherlands
    • Jeroen Bosch Ziekenhuis
  • Heerlen, Netherlands
    • Atrium Medisch Centrum Heerlen
  • Maastricht, Netherlands
    • Academisch Ziekenhuis Maastricht
  • Meppel, Netherlands
    • Diaconessenhuis Meppel
  • Nijmegen, Netherlands
    • UMCN
  • Venlo, Netherlands
    • VieCuri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aspirin; Ascal 100mg once daily	Procedure: Transoesophageal echocardiography; TEE; Other Names: No other names
Active Comparator: Coumarin derivates; Acenocoumarol or fenprocoumon	Procedure: Transoesophageal echocardiography; TEE; Other Names: No other names

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
A composite of the following endpoints: ischemic stroke, systemic embolism, major bleeding, acute coronary syndrome, death.	at least 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Completion of a technical adequate TTE/TEE on the four echocardiographic features of high stroke risk.	1 year

Collaborators and Investigators

• Sponsor: The Interuniversity Cardiology Institute of the Netherlands
• Investigators: Study Chair: HJGM Crijns, MD, PhD, Academisch Ziekenhuis Maastricht

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: September 21, 2005
• First Submitted That Met QC Criteria: September 21, 2005
• First Posted (Estimate): September 23, 2005

Study Record Updates

• Last Update Posted (Estimate): September 7, 2011
• Last Update Submitted That Met QC Criteria: September 5, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Echocardiography
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Stroke; Atrial Fibrillation
• Other Study ID Numbers: 0415