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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NHT Dinh, The Interuniversity Cardiology Institute of the Netherlands
ClinicalTrials.gov Identifier:
NCT00224757
First received: September 21, 2005
Last updated: September 5, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Stroke
Procedure: Transoesophageal echocardiography

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Transesophageal Echocardiography to Identify pAtients With Low Risk of Stroke in Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by The Interuniversity Cardiology Institute of the Netherlands:

Primary Outcome Measures:
  • A composite of the following endpoints: ischemic stroke, systemic embolism, major bleeding, acute coronary syndrome, death. [ Time Frame: at least 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Completion of a technical adequate TTE/TEE on the four echocardiographic features of high stroke risk. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 227
Study Start Date: September 2005
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aspirin
Ascal 100mg once daily
Procedure: Transoesophageal echocardiography
TEE
Other Name: No other names
Active Comparator: Coumarin derivates
Acenocoumarol or fenprocoumon
Procedure: Transoesophageal echocardiography
TEE
Other Name: No other names

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00224757

Locations
Netherlands
Twenteborg
Almelo, Netherlands
VUMC
Amsterdam, Netherlands
Rijnstate Ziekenhuis
Arnhem, Netherlands
Amphia Ziekenhuis
Breda, Netherlands
Jeroen Bosch Ziekenhuis
Den Bosch, Netherlands
Atrium Medisch Centrum Heerlen
Heerlen, Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands
Diaconessenhuis Meppel
Meppel, Netherlands
UMCN
Nijmegen, Netherlands
Viecuri
Venlo, Netherlands
Sponsors and Collaborators
The Interuniversity Cardiology Institute of the Netherlands
Investigators
Study Chair: HJGM Crijns, MD, PhD Academisch Ziekenhuis Maastricht
  More Information

No publications provided

Responsible Party: NHT Dinh, Drs., The Interuniversity Cardiology Institute of the Netherlands
ClinicalTrials.gov Identifier: NCT00224757     History of Changes
Other Study ID Numbers: 0415
Study First Received: September 21, 2005
Last Updated: September 5, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by The Interuniversity Cardiology Institute of the Netherlands:
Echocardiography

Additional relevant MeSH terms:
Atrial Fibrillation
Stroke
Cerebral Infarction
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 20, 2014