The Austrian Paradoxical Cerebral Embolism Trial "TACET"

Completed

Phase N/A Results

Trial Description

To document the baseline characteristics and 2-year follow-up results of individually selected diagnostic and treatment strategies in a cohort of stroke/TIA patients in whom contrast transesophageal echocardiography (cTEE) demonstrated cardiac-(patent foramen ovale, PFO, atrial septal defect, ASD) or pulmonary right-to-left shunts (RLS).

Interventions

  • Clopidogrel (Plavix┬«)Drug
    Other Names: Plavix
    Intervention Desc: Antiplatelet agent
  • Dipyridamole (Persantine┬«)Drug
    Intervention Desc: Platelet aggregation inhibitor
  • Anticoagulants Drug
  • PFO/ASD transcatheter closure Procedure/Surgery
    Intervention Desc: Percutaneous closure of the defect.
  • Surgical Closure Procedure/Surgery
    Intervention Desc: closing of PFO using surgical procedure
  • Aspirin Drug
    Other Names: clopidogrel; combination aspirin-dipyridamole
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2; antipyretic

Trial Design

Prospective, national, multi-center, non randomized trial (registry)

Patient Involvement

Patients are individually assigned to best medical therapy or PFO/ASD closure. Best medical therapy treatment options include aspirin alone, aspirin combined with dipyridamole, clopidogrel alone or phenprocoumon alone. Scheduled visits at discharge, 6 months, 1 and 2 years.

Outcomes

Type Measure Time Frame Safety Issue
Primary Comparison of medical versus interventional therapy in regard to stroke/TIA recurrence and intervention-related complications.
Secondary Comparison of cTEE results with cTCD in regard to: sensitivity of cardiac and pulmonary RLS detection by means of cTCD, assessment of shunt size and assessment of postinterventional residual shunts.

Sponsors

Austrian Society for Stroke Research