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

Completed

Phase N/A Results N/A

Trial Description

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
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.

Conditions

Interventions

  • Trans-oesophageal echocardiography Procedure/Surgery
    Intervention Desc: ECHO of heart using a probe inserted thru the mouth into the esophagus
  • Transoesophageal echocardiography Procedure
    Other Names: No other names
    Intervention Desc: TEE
    ARM 1: Kind: Experimental
    Label: Aspirin
    Description: Ascal 100mg once daily
    ARM 2: Kind: Experimental
    Label: Coumarin derivates
    Description: Acenocoumarol or fenprocoumon

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

TEE will be performed in patients with AF 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 randomization. TEE will be performed in all other patients to detect or exclude complex aorta plaques or signs of left atrial stasis; 300 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.

Outcomes

Type Measure Time Frame Safety Issue
Primary A composite of the following endpoints; ischemic stroke; systemic embolism; major bleeding (including haemorrhagic stroke); acute coronary syndrome (unstable angina and myocardial infarction); mortality.
Secondary Completion of a technical adequate TTE/TEE on the four echocardiographic features of high stroke risk.
Primary A composite of the following endpoints: ischemic stroke, systemic embolism, major bleeding, acute coronary syndrome, death. at least 1 year Yes

Sponsors