Transesophageal Echocardiography to Identify pAtients With Low Risk of Stroke in Atrial Fibrillation - TIARA Pilot Study
TIARA
1 other identifier
interventional
227
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable atrial-fibrillation
Started Sep 2005
Typical duration for not_applicable atrial-fibrillation
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 21, 2005
CompletedFirst Posted
Study publicly available on registry
September 23, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedSeptember 7, 2011
September 1, 2011
4 years
September 21, 2005
September 5, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
A composite of the following endpoints: ischemic stroke, systemic embolism, major bleeding, acute coronary syndrome, death.
at least 1 year
Secondary Outcomes (1)
Completion of a technical adequate TTE/TEE on the four echocardiographic features of high stroke risk.
1 year
Study Arms (2)
Aspirin
ACTIVE COMPARATORAscal 100mg once daily
Coumarin derivates
ACTIVE COMPARATORAcenocoumarol or fenprocoumon
Interventions
Eligibility Criteria
You may qualify if:
- Documented atrial fibrillation or atrial flutter, paroxysmal or permanent
- Conventional indication for VKA treatment
- Signed informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
Twenteborg
Almelo, Netherlands
VUMC
Amsterdam, Netherlands
Rijnstate Ziekenhuis
Arnhem, Netherlands
Amphia Ziekenhuis
Breda, Netherlands
Atrium Medisch Centrum Heerlen
Heerlen, Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands
Diaconessenhuis Meppel
Meppel, Netherlands
UMCN
Nijmegen, Netherlands
Viecuri
Venlo, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
HJGM Crijns, MD, PhD
Academisch Ziekenhuis Maastricht
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Drs.
Study Record Dates
First Submitted
September 21, 2005
First Posted
September 23, 2005
Study Start
September 1, 2005
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
September 7, 2011
Record last verified: 2011-09