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The multi-center, prospective PRODAST study is investigating patients with non-valvular atrial fibrillation (AF) who experienced an ischemic stroke or a transient ischemic attack (TIA) recently (≤ 1 week) both with and without previous oral anticoagulation. It consists of a baseline visit and a 3 months central follow-up for patients who were discharged with dabigatran, vitamin K-antagonists, antiplatelets only, or no oral antithrombotic treatment at all. Thus, data on the use of dabigatran and vitamin K-antagonists in routine clinical practice will be collected to describe how dabigatran is prescribed and used in the population of AF patients with recent cerebrovascular events and how these factors influence important outcome and safety events. The utilization of dabigatran will be assessed with regards to treatment persistence, compliance, proportion of patients discontinuing treatment and reason for discontinuation as well clinical endpoints such as major bleeding, stroke or systemic embolism. Due to the fact that patients will be treated according to local medical practice it is possible that medication will be changed during the observation period. In the follow-up, data from the first as well as from the second prescribed medication will be used in the study. To explore a long-term effect of anticoagulation, survival up to one year will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| investigational group | early/late dabigatran | ||
| control group | vitamin k antagonist (vka) |
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| Measure | Description | Time Frame |
|---|---|---|
| Major bleeding event rate | Major bleeding event rate within 3 months following the index event (= stroke or TIA) | from study inclusion up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complications during hospitalisation | Complications during hospitalisation before study inclusion (= signature of informed consent) | from index event up to 1 week |
| Number of participants with newly occurring or recurrent strokes |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with recent (≤ 1 week from index) ischemic stroke or TIA and with confirmed non-valvular AF (documented by 12 lead ECG, ECG rhythm strip, pacemaker/ICD electrocardiogram, or Holter ECG) will be included.
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| Name | Affiliation | Role |
|---|---|---|
| Hans Diener, Prof. Dr. | University Hospital, Essen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Altenburger Land GmbH | Altenburg | 04600 | Germany | |||
| Kreisklinik Altötting |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39895532 | Derived | Grosse GM, Husing A, Stang A, Kuklik N, Brinkmann M, Grond M, Rollnik JD, Marquardt L, Kraft A, Schlemm E, Eggers C, Eschenfelder CC, Weimar C, Diener HC. Prior Anticoagulation and Risk of Hemorrhagic Transformation in Acute Stroke: A Post Hoc Analysis of the PRODAST Study. J Am Heart Assoc. 2025 Feb 4;14(3):e037014. doi: 10.1161/JAHA.124.037014. Epub 2025 Feb 3. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 24, 2018 | Nov 27, 2018 |
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Stroke (hemorrhagic, ischemic or uncertain classification)
| from study inclusion up to 3 months |
| Severity of stroke assessed by modified Rankin Scale (mRS) | from study inclusion up to 3 months |
| Number of participants with newly occurring or recurrent TIA | transient ischemic attack | from study inclusion up to 3 months |
| Number of participants with systemic embolism | from study inclusion up to 3 months |
| Number of participants with pulmonary embolism | from study inclusion up to 3 months |
| Number of participants with myocardial infarction | from study inclusion up to 3 months |
| Life-threatening bleeding events | from study inclusion up to 3 months |
| Any cause of death | any cause of death (non-vascular, vascular or unknown cause) | from study inclusion up to 3 months |
| Point in time for withdrawal/change of medication | from study inclusion up to 3 months |
| Reason for withdrawal/change of medication | from study inclusion up to 3 months |
| Patient compliance | from study inclusion up to 3 months |
| Treatment persistence | from study inclusion up to 3 months |
| (Serious) Adverse Events (AE/SAE) | from study inclusion up to 3 months |
| Survival one year after study inclusion | any cause of death (non-vascular, vascular or unknown cause) | up to 1 year from study inclusion |
| Altötting |
| 84503 |
| Germany |
| Schön Klinik Bad Aibling | Bad Aibling | 83043 | Germany |
| Hochtaunus-Kliniken gGmbH, Krankenhaus Bad Homburg | Bad Homburg | 61352 | Germany |
| Neurologische Klinik Bad Neustadt a. d. Saale | Bad Neustadt an der Saale | 97616 | Germany |
| Klinikum Bayreuth | Bayreuth | 95445 | Germany |
| Vivantes Auguste-Viktoria Klinikum | Berlin | 12157 | Germany |
| Vivantes Klinikum Neukölln | Berlin | 12351 | Germany |
| Unfallkrankenhaus Berlin | Berlin | 12683 | Germany |
| Vivantes Humboldt Klinikum GmbH | Berlin | 13509 | Germany |
| Evangelisches Krankenhaus Bielefeld gGmbH | Bielefeld | 33611 | Germany |
| Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH | Bochum | 44789 | Germany |
| St. Josef Hospital Ruhr University Bochum | Bochum | 44791 | Germany |
| Universitätsklinikum Bonn | Bonn | 53127 | Germany |
| Knappschaftskrankenhaus Bottrop GmbH | Bottrop | 46242 | Germany |
| Klinikum Bremerhaven-Reinkenheide gGmbH | Bremerhaven | 27574 | Germany |
| Krankenhaus Buchholz und Winsen gGmbH | Buchholz | 21244 | Germany |
| Evangelisches Krankenhaus Castrop-Rauxel | Castrop-Rauxel | 44577 | Germany |
| Allgemeines Krankenhaus Celle | Celle | 29223 | Germany |
| REGIOMED-Kliniken - Klinikum Coburg | Coburg | 96450 | Germany |
| Universitätsklinikum Köln | Cologne | 50924 | Germany |
| Krankenhaus St. Elisabeth gGmbH | Damme | 49401 | Germany |
| Klinikum Dortmund gGmbH | Dortmund | 44137 | Germany |
| Städtisches Klinikum Dresden-Neustadt | Dresden | 01129 | Germany |
| Universitätsklinikum Carl Gustav Carus Dresden | Dresden | 01304 | Germany |
| Evangelisches Klinikum Niederrhein gGmbH | Duisburg | 47169 | Germany |
| Klinikum Emden, Hans-Susemihl Krankenhaus | Emden | 26721 | Germany |
| Alfried Krupp Krankenhaus Rüttenscheid | Essen | 45131 | Germany |
| University Hospital Essen, Department of Neurology | Essen | 45147 | Germany |
| Klinikum Frankfurt Höchst GmbH | Frankfurt | 65929 | Germany |
| Klinikum der Johann Wolfgang Goethe-Universität | Frankfurt am Main | 60528 | Germany |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Klinikum Fulda gAG | Fulda | 36043 | Germany |
| Evangelische Kliniken Gelsenkirchen gGmbH | Gelsenkirchen | 45879 | Germany |
| SRH Wald-Klinikum Gera GmbH | Gera | 07548 | Germany |
| Universitätsmedizin Göttingen, Georg-August-Universität | Göttingen | 37075 | Germany |
| Klinikum Oberberg - Kreiskrankenhaus Gummersbach GmbH | Gummersbach | 51643 | Germany |
| Krankenhaus Martha-Maria Halle-Dölau | Halle | 06056 | Germany |
| UKH Universitätsklinikum Halle (Saale) | Halle | 06120 | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Asklepios Klinik Wandsbek | Hamburg | 22043 | Germany |
| Asklepios Klinik Barmbek | Hamburg | 22291 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Evangelisches Krankenhaus Hattingen gGmbH | Hattingen | 45525 | Germany |
| Krankenhaus Agatharied GmbH | Hausham | 83734 | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Evangelisches Krankenhaus Herne | Herne | 44623 | Germany |
| BDH-Klinik Hessisch-Oldendorf GmbH | Hessisch Oldendorf | 31840 | Germany |
| Klinikum Ibbenbüren GmbH | Ibbenbueren | 49477 | Germany |
| Klinikum Idar-Oberstein GmbH | Idar-Oberstein | 55743 | Germany |
| SHR Klinikum Karlsbad-Langensteinbach GmbH | Karlsbad | 76307 | Germany |
| Universitätsklinikum Schleswig-Holstein, Campus Kiel | Kiel | 24105 | Germany |
| Alexianer Krefeld GmbH, Krankenhaus Maria-Hilf | Krefeld | 47805 | Germany |
| Universitätsklinikum Leipzig AöR | Leipzig | 04103 | Germany |
| Klinikum Main-Spessart, Krankenhaus Lohr | Lohr | 97816 | Germany |
| Klinikum der Stadt Ludwigshafen gGmbH | Ludwigshafen | 67063 | Germany |
| Universitätsklinikum Schleswig-Holstein Campus Lübeck | Lübeck | 23538 | Germany |
| Sana Kliniken Luebeck GmbH | Lübeck | 23560 | Germany |
| Städtisches Klinikum Lüneburg gGmbH | Lüneburg | 21339 | Germany |
| St.-Marien-Hospital GmbH | Lünen | 44534 | Germany |
| Universitätsklinikum Magdeburg | Magdeburg | 39120 | Germany |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz | Mainz | 55131 | Germany |
| Universitätsmedizin Mannheim | Mannheim | 68167 | Germany |
| Klinikum Merzig | Merzig | 66663 | Germany |
| Mühlenkreiskliniken AöR, Johannes Wesling Klinikum Minden | Minden | 32492 | Germany |
| St. Josef Krankenhaus GmbH Moers | Moers | 47441 | Germany |
| Kliniken Maria Hilf GmbH | Mönchengladbach | 41063 | Germany |
| UKM Universitätsklinikum Münster | Münster | 48149 | Germany |
| Dietrich-Bonhoeffer-Klinikum Neubrandenburg | Neubrandenburg | 17036 | Germany |
| Klinikum Osnabrück GmbH | Osnabrück | 49076 | Germany |
| Klinikum Vest GmbH, Behandlungszentrum Knappschaftskrankenhaus Recklinghausen | Recklinghausen | 45657 | Germany |
| Imland Klinik Rendsburg | Rendsburg | 24768 | Germany |
| Klinikum Saarbrücken gGmbH | Saarbrücken | 66119 | Germany |
| Nordwest-Krankenhaus Sanderbusch | Sande | 26452 | Germany |
| Diakonie-Klinikum Schwäbisch Hall gGmbH | Schwäbisch Hall | 74523 | Germany |
| ASKLEPIOS Kliniken Schildautal Seesen | Seesen | 38723 | Germany |
| Kreisklinikum Siegen | Siegen | 57076 | Germany |
| Medinos Kliniken Sonneberg | Sonneberg | 96515 | Germany |
| Klinikum Stuttgart - Katharinenhospital | Stuttgart | 70174 | Germany |
| SRH Zentralklinikum Suhl GmbH | Suhl | 98527 | Germany |
| Asklepios Fachklinikum Teupitz | Teupitz | 15755 | Germany |
| Universitätsklinikum Tübingen | Tübingen | 72076 | Germany |
| RKU - Universitäts- und Rehabilitationskliniken Ulm gGmbH | Ulm | 89081 | Germany |
| Ammerland Klinik GmbH | Westerstede | 26655 | Germany |
| HELIOS Dr. Horst Schmidt Kliniken Wiesbaden | Wiesbaden | 65199 | Germany |
| Rems-Murr-Klinikum Winnenden | Winnenden | 71364 | Germany |
| Sana HANSE-Klinikum Wismar | Wismar | 23966 | Germany |
| Klinikum Wolfsburg | Wolfsburg | 38440 | Germany |
| Rhein-Maas-Klinikum GmbH | Würselen | 52146 | Germany |
| Universitätsklinikum Würzburg AöR | Würzburg | 97080 | Germany |
| Prot_001.pdf |