Brain Ischemia With Non-valvular Atrial Fibrillation Clinical Trial
— PRODASTOfficial title:
Prospective Record Of the Use of Dabigatran in Patients With Acute Stroke or TIA
| NCT number | NCT02507856 |
| Other study ID # | PRODAST |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 2015 |
| Est. completion date | April 2022 |
| Verified date | May 2022 |
| Source | University Hospital, Essen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 10044 |
| Est. completion date | April 2022 |
| Est. primary completion date | December 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Klinikum Altenburger Land GmbH | Altenburg | |
| Germany | Kreisklinik Altötting | Altötting | |
| Germany | Schön Klinik Bad Aibling | Bad Aibling | |
| Germany | Hochtaunus-Kliniken gGmbH, Krankenhaus Bad Homburg | Bad Homburg | |
| Germany | Neurologische Klinik Bad Neustadt a. d. Saale | Bad Neustadt an der Saale | |
| Germany | Klinikum Bayreuth | Bayreuth | |
| Germany | Unfallkrankenhaus Berlin | Berlin | |
| Germany | Vivantes Auguste-Viktoria Klinikum | Berlin | |
| Germany | Vivantes Humboldt Klinikum GmbH | Berlin | |
| Germany | Vivantes Klinikum Neukölln | Berlin | |
| Germany | Evangelisches Krankenhaus Bielefeld gGmbH | Bielefeld | |
| Germany | Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH | Bochum | |
| Germany | St. Josef Hospital Ruhr University Bochum | Bochum | |
| Germany | Universitätsklinikum Bonn | Bonn | |
| Germany | Knappschaftskrankenhaus Bottrop GmbH | Bottrop | |
| Germany | Klinikum Bremerhaven-Reinkenheide gGmbH | Bremerhaven | |
| Germany | Krankenhaus Buchholz und Winsen gGmbH | Buchholz | |
| Germany | Evangelisches Krankenhaus Castrop-Rauxel | Castrop-Rauxel | |
| Germany | Allgemeines Krankenhaus Celle | Celle | |
| 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 Frankfurt Höchst GmbH | Frankfurt | |
| Germany | Klinikum der Johann Wolfgang Goethe-Universität | Frankfurt am Main | |
| Germany | Universitätsklinikum Freiburg | Freiburg | |
| Germany | Klinikum Fulda gAG | Fulda | |
| Germany | Evangelische Kliniken Gelsenkirchen gGmbH | Gelsenkirchen | |
| Germany | SRH Wald-Klinikum Gera GmbH | Gera | |
| Germany | Universitätsmedizin Göttingen, Georg-August-Universität | Göttingen | |
| Germany | Klinikum Oberberg - Kreiskrankenhaus Gummersbach GmbH | Gummersbach | |
| Germany | UKH Universitätsklinikum Halle (Saale) | Halle | |
| Germany | Krankenhaus Martha-Maria Halle-Dölau | Halle (Saale) | |
| Germany | Asklepios Klinik Barmbek | Hamburg | |
| Germany | Asklepios Klinik Wandsbek | Hamburg | |
| Germany | Universitätsklinikum Hamburg-Eppendorf | Hamburg | |
| Germany | Medizinische Hochschule Hannover | Hannover | |
| Germany | Evangelisches Krankenhaus Hattingen gGmbH | Hattingen | |
| Germany | Krankenhaus Agatharied GmbH | Hausham | |
| Germany | Universitätsklinikum Heidelberg | Heidelberg | |
| Germany | Evangelisches Krankenhaus Herne | Herne | |
| Germany | BDH-Klinik Hessisch-Oldendorf GmbH | Hessisch Oldendorf | |
| Germany | Klinikum Ibbenbüren GmbH | Ibbenbüren | |
| Germany | Klinikum Idar-Oberstein GmbH | Idar-Oberstein | |
| Germany | SHR Klinikum Karlsbad-Langensteinbach GmbH | Karlsbad | |
| Germany | Universitätsklinikum Schleswig-Holstein, Campus Kiel | Kiel | |
| Germany | Universitätsklinikum Köln | Köln | |
| Germany | Alexianer Krefeld GmbH, Krankenhaus Maria-Hilf | Krefeld | |
| Germany | Universitätsklinikum Leipzig AöR | Leipzig | |
| Germany | Klinikum Main-Spessart, Krankenhaus Lohr | Lohr | |
| Germany | Sana Kliniken Luebeck GmbH | Lübeck | |
| Germany | Universitätsklinikum Schleswig-Holstein Campus Lübeck | Lübeck | |
| Germany | Klinikum der Stadt Ludwigshafen gGmbH | Ludwigshafen | |
| Germany | Städtisches Klinikum Lüneburg gGmbH | Lüneburg | |
| Germany | St.-Marien-Hospital GmbH | Lünen | |
| Germany | Universitätsklinikum Magdeburg | Magdeburg | |
| 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 | Nordwest-Krankenhaus Sanderbusch | Sande | |
| Germany | Diakonie-Klinikum Schwäbisch Hall gGmbH | Schwäbisch Hall | |
| Germany | ASKLEPIOS Kliniken Schildautal Seesen | Seesen | |
| Germany | Kreisklinikum Siegen | Siegen | |
| Germany | Medinos Kliniken Sonneberg | Sonneberg | |
| Germany | Klinikum Stuttgart - Katharinenhospital | Stuttgart | |
| Germany | SRH Zentralklinikum Suhl GmbH | Suhl | |
| Germany | Asklepios Fachklinikum Teupitz | Teupitz | |
| Germany | Universitätsklinikum Tübingen | Tübingen | |
| Germany | RKU - Universitäts- und Rehabilitationskliniken Ulm gGmbH | Ulm | |
| Germany | Ammerland Klinik GmbH | Westerstede | |
| Germany | HELIOS Dr. Horst Schmidt Kliniken Wiesbaden | Wiesbaden | |
| Germany | Rems-Murr-Klinikum Winnenden | Winnenden | |
| Germany | Sana HANSE-Klinikum Wismar | Wismar | |
| Germany | Klinikum Wolfsburg | Wolfsburg | |
| Germany | Rhein-Maas-Klinikum GmbH | Würselen | |
| Germany | Universitätsklinikum Würzburg AöR | Würzburg |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Essen |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | Complications during hospitalisation | Complications during hospitalisation before study inclusion (= signature of informed consent) | from index event up to 1 week | |
| Secondary | Number of participants with newly occurring or recurrent strokes | Stroke (hemorrhagic, ischemic or uncertain classification) | from study inclusion up to 3 months | |
| Secondary | Severity of stroke assessed by modified Rankin Scale (mRS) | from study inclusion up to 3 months | ||
| Secondary | Number of participants with newly occurring or recurrent TIA | transient ischemic attack | from study inclusion up to 3 months | |
| Secondary | Number of participants with systemic embolism | from study inclusion up to 3 months | ||
| Secondary | Number of participants with pulmonary embolism | from study inclusion up to 3 months | ||
| Secondary | Number of participants with myocardial infarction | from study inclusion up to 3 months | ||
| Secondary | Life-threatening bleeding events | from study inclusion up to 3 months | ||
| Secondary | Any cause of death | any cause of death (non-vascular, vascular or unknown cause) | from study inclusion up to 3 months | |
| Secondary | Point in time for withdrawal/change of medication | from study inclusion up to 3 months | ||
| Secondary | Reason for withdrawal/change of medication | from study inclusion up to 3 months | ||
| Secondary | Patient compliance | from study inclusion up to 3 months | ||
| Secondary | Treatment persistence | from study inclusion up to 3 months | ||
| Secondary | (Serious) Adverse Events (AE/SAE) | from study inclusion up to 3 months | ||
| Secondary | Survival one year after study inclusion | any cause of death (non-vascular, vascular or unknown cause) | up to 1 year from study inclusion |