Atrial FibrillationTIARANCT00224757
Transesophageal Echocardiography to Identify pAtients With Low Risk of Stroke in Atrial Fibrillation - TIARA Pilot Study
A study testing Transoesophageal echocardiography in people with Atrial Fibrillation and Stroke, run by The Interuniversity Cardiology Institute of the Netherlands at 10 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Stroke
- What is being tested?
- Transoesophageal echocardiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 10 sitesNetherlands
- Study dates
- Sep 2005to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented atrial fibrillation or atrial flutter, paroxysmal or permanent
- Conventional indication for VKA treatment
- Signed informed consent
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Netherlands10 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch
Twenteborg
Almelo
VUMC
Amsterdam
Rijnstate Ziekenhuis
Arnhem
Amphia Ziekenhuis
Breda
Atrium Medisch Centrum Heerlen
Heerlen
Academisch Ziekenhuis Maastricht
Maastricht
Diaconessenhuis Meppel
Meppel
UMCN
Nijmegen
Viecuri
Venlo
About this study
Official title: 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.
Read the 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
- To show that TEE based aspirin treatment is safe when compared with VKA therapy.
- 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.
- Conditions
- Atrial Fibrillation, Stroke
- Being tested
- Transoesophageal echocardiography
- Keywords
- Echocardiography
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transoesophageal echocardiographyProcedure or surgery
Also called No other names
TEE
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Active comparator | Ascal 100mg once daily Receives: Procedure: Transoesophageal echocardiography |
| Coumarin derivates | Active comparator | Acenocoumarol or fenprocoumon Receives: Procedure: Transoesophageal echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite of the following endpoints: ischemic stroke, systemic embolism, major bleeding, acute coronary syndrome, death.
Measured: at least 1 year
Secondary outcomes (1)
Completion of a technical adequate TTE/TEE on the four echocardiographic features of high stroke risk.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Interuniversity Cardiology Institute of the Netherlands
- Sponsor type
- Other government
- Responsible party
- Principal investigator, NHT Dinh, The Interuniversity Cardiology Institute of the Netherlands
- Investigators
- HJGM Crijns, MD, PhD, Study chair, Academisch Ziekenhuis Maastricht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00224757
- Sponsor's protocol ID
- 0415
- Acronym
- TIARA
- Status last verified
- Sep 2011
- First submitted
- 21 Sep 2005
- Last updated
- 7 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transesophageal Echocardiography to Identify pAtients With Low Risk of Stroke in Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00224757
- Acronym / sponsor ID
- TIARA / 0415
- Conditions
- Atrial Fibrillation, Stroke
- Keywords
- Echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- The Interuniversity Cardiology Institute of the NetherlandsOther government
- Study start
- Sep 2005
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 23 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To show that TEE based aspirin treatment is safe when compared with VKA therapy.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Active comparator | Procedure: Transoesophageal echocardiographyAscal 100mg once daily |
| Coumarin derivates | Active comparator | Procedure: Transoesophageal echocardiographyAcenocoumarol or fenprocoumon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Documented atrial fibrillation or atrial flutter, paroxysmal or permanent
- Conventional indication for VKA treatment
- Signed informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transoesophageal echocardiographyAlso: No other namesTEE | Procedure or surgery | Aspirin, Coumarin derivates |
Primary outcome
A composite of the following endpoints: ischemic stroke, systemic embolism, major bleeding, acute coronary syndrome, death.
Time frame: at least 1 year
1 secondary outcome
Completion of a technical adequate TTE/TEE on the four echocardiographic features of high stroke risk.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2011.
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HJGM Crijns, MD, PhD study chair
Academisch Ziekenhuis Maastricht
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transoesophageal echocardiography in people with Atrial Fibrillation and Stroke, run by The Interuniversity Cardiology Institute of the Netherlands at 10 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite of the following endpoints: ischemic stroke, systemic embolism, major bleeding, acute coronary syndrome, death. (time frame: at least 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2011.