Aktuelle klinische Studien
Zerebrovaskuläre Erkrankungen
| Thema | Kurztitel/Akronym | Studientitel | Kurzbeschreibung | Phase | Status | Verantwortlicher |
| Antiinflammatorische Sekundärprävention nach nicht kardioembolischem Schlaganfall | CONVINCE | COlchicine for prevention of Vascular Inflammation in Non-CardioEmbolic stroke) – a randomised clinical trial of low-dose colchicine for secondary prevention after stroke | To investigate the efficacy of low dose colchicine (0.5mg/day) plus usual care (defined as antiplatelet, lipid-lowering, antihypertensive treatment, and appropriate lifestyle advice) compared with usual care alone to prevent non-fatal recurrent ischaemic stroke, myocardial infarction, cardiac arrest, hospitalization for unstable angina and vascular death after ischaemic stroke or transient ischaemic attack (TIA) not caused by cardiac embolism or other defined causes unrelated to atherosclerosis | III | Rekrutierung läuft | Prof. Dr. med. M. Görtler |
| Sekundärprävention nach intrazerebraler Blutung bei Patienten mit Vorhofflimmern | CLEARANCE | Randomized Comparison of interventional cLosure of the lEft atrial Appendage using a LAA closure device versus oRal Anticoagulation therapy in patients with Non-valvular atrial fibrillation and status post intraCranial bleeding | Study goal is to determine the clinical benefit of percutaneous catheter-based left atrial appendage (LAA) closure in patients with non-valvular atrial fibrillation (NVAF) at high risk of stroke (CHA2DS2‐VASc Score ≥2) suffering from an intracranial hemorrhage as compared to best medical care | II/III | Rekrutierung läuft | Prof. Dr. med. R. Braun-Dullaeus / Prof. Dr.med. M. Görtler |
| Sekundärprävention nach embolischem Schlaganfall unbekannten Ursprungs (ESUS) | ATTICUS | Apixaban for TreatmenT of Embolic stroke of UndeterminedSource | To show that apixaban has superior efficacy over ASA (standard of care) to reduce the rate of new ischemic lesions detected by cerebralFLAIR/DWI weighted MRI in patients with Embolic Stroke of Unknown Source (ESUS) | III | Rekrutierung abgeschlossen | Prof. Dr.med. M. Görtler |
Schlaganfall-Akuttherapie
| Thema | Kurztitel/Akronym | Studientitel | Kurzbeschreibung | Phase | Status | Verantwortlicher |
| Wirksamkeit und Sicherheit der endovaskulären Thrombektomie bei ausgedehnten Infarktfrühzeichen im erweiterten Zeitfenster | TENSION | Efficacy and safety of ThrombEctomy iN Stroke with extended leSION and extended time window: a randomized, controlled trial | The primary objective of this study is to test efficacy and safety of thrombectomy in acute stroke patients with uncertain benefit of endovascular stroke treatment, i.e. extended ischemic lesion size with an ASPECT score of 3-5 up to 12 hours from symptom onset or last seen well as compared to best medical care alone. | III | Rekrutierung läuft | Prof. Dr. med. M. Görtler / PD Dr. med. D. Behme |
| Wirksamkeit eines DOAK-Antidot bei Patienten mit akuter intrazerebraler Blutung, die mit Rivaroxaban bzw. Apixaban antikoaguliert sind | ASTRO-DE | Andexanet alfa: non-interventional study in Stroke Units in Germany (DE) | To assess the change in size or volume of the hematoma by CT or MRI in patients with intracranial bleeding (intracranial hemorrhage, ICH) under rivaroxaban and apixaban treated with andexanet alfa. | IV | In Vorbereitung | Prof. Dr. med. M. Görtler |
| Wirksamkeit der alleinigen Thrombektomie gegenüber einer Thrombektomie mit zusätzlich intravenöser Thrombolyse beim ischämischen Schlaganfall | SWIFT DIRECT | Solitaire™With the Intention For Thrombectomy plus intravenous t-PA versus DIRECT Solitaire™ stent retriever thrombectomy in acute anterior circulation stroke | The primary objective of this randomized trial is to determine whether subjects experiencing an AIS due to large intracranial vessel occlusion in the anterior circulation who are referred to a stroke centre with endovascular facilities and who are candidates for IV t-PA will have non- inferior functional outcome at 90 days when treated with direct MT compared to subjects treated with combined IV t-PA and MT | III | Beendet | Prof. Dr. med. M. Görtler / PD Dr. med. D. Behme |
Schlaganfall-Rehabilitation
| Thema | Kurztitel/Akronym | Studientitel | Kurzbeschreibung | Phase | Status | Verantwortlicher |
| BCI in der Frühphase der Rehabilitation nach Schlaganfall | / | Motorische Rehabilitation nach akutem Schlaganfall durch von Gehirnsignalen gesteuerte muskuläre Stimulation | Studienziel ist die Prüfung, ob Patienten mit einer Brain-Computer-Interface- (BCI-)unterstützten Frührehabilitation ein besseres neurologisches und funktionelles Outcome haben als Patienten ohne BCI-Unterstützung | II/III | Rekrutierung abgeschlossen | Prof. Dr. C. Sweeney-Reed |