Prospective Record Of the Use of Dabigatran in Patients With Acute Stroke or TIA
- Conditions
- Transient Ischemic Attack With Non-valvular Atrial FibrillationBrain Ischemia With Non-valvular Atrial Fibrillation
- Registration Number
- NCT02507856
- Lead Sponsor
- University Hospital, Essen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10044
- Age ≥18 years at enrollment
- Male or female patient willing and able to provide written informed consent for data transmission. For patients who are not legally competent to sign this informed consent for data transmission exceptions/special cases are described in the protocol.
- Patient with ischemic stroke or TIA within the last 7 days.
- Patient diagnosed with non-valvular AF. Documentation of AF by 12 lead ECG, ECG rhythm strip, monitor print-out, pacemaker/ICD electrocardiogram, Holter ECG (duration of AF episode at least 30 seconds) or written physician´s diagnosis prior to index event needed for all enrolled patients.
- Presence of any mechanical heart valve, or valve disease that is expected to require valve replacement intervention (surgical or non-surgical) during the next 3 months.
- Current participation in any randomized clinical trial of an experimental drug or device.
- Women of childbearing age without anamnestic exclusion of pregnancy or not using an effective contraception or nursing mothers.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Major bleeding event rate from study inclusion up to 3 months Major bleeding event rate within 3 months following the index event (= stroke or TIA)
- Secondary Outcome Measures
Name Time Method Complications during hospitalisation from index event up to 1 week Complications during hospitalisation before study inclusion (= signature of informed consent)
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 Severity of stroke assessed by modified Rankin Scale (mRS) from study inclusion up to 3 months Patient compliance from study inclusion up to 3 months (Serious) Adverse Events (AE/SAE) from study inclusion up to 3 months Number of participants with newly occurring or recurrent TIA from study inclusion up to 3 months transient ischemic attack
Number of participants with newly occurring or recurrent strokes from study inclusion up to 3 months Stroke (hemorrhagic, ischemic or uncertain classification)
Reason for withdrawal/change of medication from study inclusion up to 3 months Survival one year after study inclusion up to 1 year from study inclusion any cause of death (non-vascular, vascular or unknown cause)
Number of participants with systemic embolism from study inclusion up to 3 months Life-threatening bleeding events from study inclusion up to 3 months Any cause of death from study inclusion up to 3 months any cause of death (non-vascular, vascular or unknown cause)
Point in time for withdrawal/change of medication from study inclusion up to 3 months Treatment persistence from study inclusion up to 3 months
Trial Locations
- Locations (90)
Klinikum Frankfurt Höchst GmbH
🇩🇪Frankfurt, Germany
Klinikum Fulda gAG
🇩🇪Fulda, Germany
Universitätsklinikum Freiburg
🇩🇪Freiburg, Germany
Klinikum Altenburger Land GmbH
🇩🇪Altenburg, Germany
Schön Klinik Bad Aibling
🇩🇪Bad Aibling, Germany
Hochtaunus-Kliniken gGmbH, Krankenhaus Bad Homburg
🇩🇪Bad Homburg, Germany
Vivantes Auguste-Viktoria Klinikum
🇩🇪Berlin, Germany
Neurologische Klinik Bad Neustadt a. d. Saale
🇩🇪Bad Neustadt an der Saale, Germany
Klinikum Bayreuth
🇩🇪Bayreuth, Germany
Vivantes Klinikum Neukölln
🇩🇪Berlin, Germany
Unfallkrankenhaus Berlin
🇩🇪Berlin, Germany
SRH Wald-Klinikum Gera GmbH
🇩🇪Gera, Germany
Vivantes Humboldt Klinikum GmbH
🇩🇪Berlin, Germany
Evangelisches Krankenhaus Bielefeld gGmbH
🇩🇪Bielefeld, Germany
St. Josef Hospital Ruhr University Bochum
🇩🇪Bochum, Germany
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH
🇩🇪Bochum, Germany
Universitätsklinikum Bonn
🇩🇪Bonn, Germany
Knappschaftskrankenhaus Bottrop GmbH
🇩🇪Bottrop, Germany
Klinikum Bremerhaven-Reinkenheide gGmbH
🇩🇪Bremerhaven, Germany
Krankenhaus Buchholz und Winsen gGmbH
🇩🇪Buchholz, Germany
Allgemeines Krankenhaus Celle
🇩🇪Celle, Germany
Evangelisches Krankenhaus Castrop-Rauxel
🇩🇪Castrop-Rauxel, Germany
REGIOMED-Kliniken - Klinikum Coburg
🇩🇪Coburg, Germany
Krankenhaus St. Elisabeth gGmbH
🇩🇪Damme, Germany
Klinikum Dortmund gGmbH
🇩🇪Dortmund, Germany
Städtisches Klinikum Dresden-Neustadt
🇩🇪Dresden, Germany
Universitätsklinikum Carl Gustav Carus Dresden
🇩🇪Dresden, Germany
Evangelisches Klinikum Niederrhein gGmbH
🇩🇪Duisburg, Germany
Klinikum Emden, Hans-Susemihl Krankenhaus
🇩🇪Emden, Germany
Alfried Krupp Krankenhaus Rüttenscheid
🇩🇪Essen, Germany
University Hospital Essen, Department of Neurology
🇩🇪Essen, Germany
Klinikum der Johann Wolfgang Goethe-Universität
🇩🇪Frankfurt am Main, Germany
Evangelische Kliniken Gelsenkirchen gGmbH
🇩🇪Gelsenkirchen, Germany
Klinikum Oberberg - Kreiskrankenhaus Gummersbach GmbH
🇩🇪Gummersbach, Germany
Universitätsmedizin Göttingen, Georg-August-Universität
🇩🇪Göttingen, Germany
Krankenhaus Martha-Maria Halle-Dölau
🇩🇪Halle (Saale), Germany
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
UKH Universitätsklinikum Halle (Saale)
🇩🇪Halle, Germany
Asklepios Klinik Wandsbek
🇩🇪Hamburg, Germany
Asklepios Klinik Barmbek
🇩🇪Hamburg, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Evangelisches Krankenhaus Hattingen gGmbH
🇩🇪Hattingen, Germany
Krankenhaus Agatharied GmbH
🇩🇪Hausham, Germany
Evangelisches Krankenhaus Herne
🇩🇪Herne, Germany
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
BDH-Klinik Hessisch-Oldendorf GmbH
🇩🇪Hessisch Oldendorf, Germany
Klinikum Idar-Oberstein GmbH
🇩🇪Idar-Oberstein, Germany
SHR Klinikum Karlsbad-Langensteinbach GmbH
🇩🇪Karlsbad, Germany
Klinikum Ibbenbüren GmbH
🇩🇪Ibbenbüren, Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
🇩🇪Kiel, Germany
Alexianer Krefeld GmbH, Krankenhaus Maria-Hilf
🇩🇪Krefeld, Germany
Universitätsklinikum Köln
🇩🇪Köln, Germany
Universitätsklinikum Leipzig AöR
🇩🇪Leipzig, Germany
Klinikum Main-Spessart, Krankenhaus Lohr
🇩🇪Lohr, Germany
Klinikum der Stadt Ludwigshafen gGmbH
🇩🇪Ludwigshafen, Germany
Universitätsklinikum Schleswig-Holstein Campus Lübeck
🇩🇪Lübeck, Germany
Sana Kliniken Luebeck GmbH
🇩🇪Lübeck, Germany
Städtisches Klinikum Lüneburg gGmbH
🇩🇪Lüneburg, Germany
Universitätsklinikum Magdeburg
🇩🇪Magdeburg, Germany
St.-Marien-Hospital GmbH
🇩🇪Lünen, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Germany
Universitätsmedizin Mannheim
🇩🇪Mannheim, Germany
Klinikum Merzig
🇩🇪Merzig, Germany
Mühlenkreiskliniken AöR, Johannes Wesling Klinikum Minden
🇩🇪Minden, Germany
St. Josef Krankenhaus GmbH Moers
🇩🇪Moers, Germany
Kliniken Maria Hilf GmbH
🇩🇪Mönchengladbach, Germany
UKM Universitätsklinikum Münster
🇩🇪Münster, Germany
Dietrich-Bonhoeffer-Klinikum Neubrandenburg
🇩🇪Neubrandenburg, Germany
Klinikum Osnabrück GmbH
🇩🇪Osnabrück, Germany
Klinikum Vest GmbH, Behandlungszentrum Knappschaftskrankenhaus Recklinghausen
🇩🇪Recklinghausen, Germany
Imland Klinik Rendsburg
🇩🇪Rendsburg, Germany
Klinikum Saarbrücken gGmbH
🇩🇪Saarbrücken, Germany
ASKLEPIOS Kliniken Schildautal Seesen
🇩🇪Seesen, Germany
Nordwest-Krankenhaus Sanderbusch
🇩🇪Sande, Germany
Diakonie-Klinikum Schwäbisch Hall gGmbH
🇩🇪Schwäbisch Hall, Germany
Kreisklinikum Siegen
🇩🇪Siegen, Germany
SRH Zentralklinikum Suhl GmbH
🇩🇪Suhl, Germany
Klinikum Stuttgart - Katharinenhospital
🇩🇪Stuttgart, Germany
Medinos Kliniken Sonneberg
🇩🇪Sonneberg, Germany
Asklepios Fachklinikum Teupitz
🇩🇪Teupitz, Germany
RKU - Universitäts- und Rehabilitationskliniken Ulm gGmbH
🇩🇪Ulm, Germany
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden
🇩🇪Wiesbaden, Germany
Sana HANSE-Klinikum Wismar
🇩🇪Wismar, Germany
Ammerland Klinik GmbH
🇩🇪Westerstede, Germany
Rems-Murr-Klinikum Winnenden
🇩🇪Winnenden, Germany
Klinikum Wolfsburg
🇩🇪Wolfsburg, Germany
Rhein-Maas-Klinikum GmbH
🇩🇪Würselen, Germany
Universitätsklinikum Würzburg AöR
🇩🇪Würzburg, Germany
Kreisklinik Altötting
🇩🇪Altötting, Germany