Prospective Record Of the Use of Dabigatran in Patients With Acute Stroke or TIA

NCT ID: NCT02507856

Last Updated: 2022-05-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10044 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2022-04-30

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.

Conditions

Brain Ischemia With Non-valvular Atrial Fibrillation; Transient Ischemic Attack With Non-valvular Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

investigational group

early/late dabigatran

No interventions assigned to this group

control group

vitamin k antagonist (vka)

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Essen

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Hans Diener

Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hans Diener, Prof. Dr.

Role: STUDY_DIRECTOR

University Hospital, Essen

Locations

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

Vivantes Auguste-Viktoria Klinikum

Berlin, , Germany

Vivantes Klinikum Neukölln

Berlin, , Germany

Unfallkrankenhaus Berlin

Berlin, , Germany

Vivantes Humboldt Klinikum GmbH

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

Universitätsklinikum Köln

Cologne, , 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 im Breisgau, , 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

Krankenhaus Martha-Maria Halle-Dölau

Halle, , Germany

UKH Universitätsklinikum Halle (Saale)

Halle, , Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Asklepios Klinik Wandsbek

Hamburg, , Germany

Asklepios Klinik Barmbek

Hamburg, , Germany

Medizinische Hochschule Hannover

Hanover, , 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

Ibbenbueren, , Germany

Klinikum Idar-Oberstein GmbH

Idar-Oberstein, , Germany

SHR Klinikum Karlsbad-Langensteinbach GmbH

Karlsbad, , Germany

Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, , Germany

Alexianer Krefeld GmbH, Krankenhaus Maria-Hilf

Krefeld, , 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

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, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 39895532 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

PRODAST

Identifier Type: -

Identifier Source: org_study_id