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).
- Clopidogrel (Plavix®)Drug
Other Names: Plavix, Clodelib, Clovelen Intervention Desc: Antiplatelet agent
- Dipyridamole (Persantine®)Drug
Intervention Desc: Platelet aggregation inhibitor
- Anticoagulants Drug
Other Names: warfarin and novel oral anticoagulants
- 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: ASA; acetylsalicylic acid Intervention Desc: Antiplatelet agent; inhibits thromboxane A2; antipyretic
Prospective, national, multi-center, non randomized trial (registry)
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.
|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.|