Clinical trial NCT02507856: Prospective Record Of the Use of Dabigatran in Patients With Acute Stroke or TIA
Official title: Prospective Record Of the Use of Dabigatran in Patients With Acute Stroke or TIA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Ischemia With Non-valvular Atrial Fibrillation
Transient Ischemic Attack With Non-valvular Atrial Fibrillation
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2015-07-24
Enrollment: 10044
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


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.

Primary outcomes:
measure: Major bleeding event rate
timeFrame: from study inclusion up to 3 months
Secondary outcomes:
measure: Complications during hospitalisation
timeFrame: from index event up to 1 week
measure: Number of participants with newly occurring or recurrent strokes
timeFrame: from study inclusion up to 3 months
measure: Severity of stroke assessed by modified Rankin Scale (mRS)
timeFrame: from study inclusion up to 3 months
measure: Number of participants with newly occurring or recurrent TIA
timeFrame: from study inclusion up to 3 months
measure: Number of participants with systemic embolism
timeFrame: from study inclusion up to 3 months
measure: Number of participants with pulmonary embolism
timeFrame: from study inclusion up to 3 months
measure: Number of participants with myocardial infarction
timeFrame: from study inclusion up to 3 months
measure: Life-threatening bleeding events
timeFrame: from study inclusion up to 3 months
measure: Any cause of death
timeFrame: from study inclusion up to 3 months
measure: Point in time for withdrawal/change of medication
timeFrame: from study inclusion up to 3 months
measure: Reason for withdrawal/change of medication
timeFrame: from study inclusion up to 3 months
measure: Patient compliance
timeFrame: from study inclusion up to 3 months
measure: Treatment persistence
timeFrame: from study inclusion up to 3 months
measure: (Serious) Adverse Events (AE/SAE)
timeFrame: from study inclusion up to 3 months
measure: Survival one year after study inclusion
timeFrame: up to 1 year from study inclusion
Other outcomes:
Locations:
city: Altenburg
country: Germany
facility: Klinikum Altenburger Land GmbH
city: Altötting
country: Germany
facility: Kreisklinik Altötting
city: Bad Aibling
country: Germany
facility: Schön Klinik Bad Aibling
city: Bad Homburg
country: Germany
facility: Hochtaunus-Kliniken gGmbH, Krankenhaus Bad Homburg
city: Bad Neustadt an der Saale
country: Germany
facility: Neurologische Klinik Bad Neustadt a. d. Saale
city: Bayreuth
country: Germany
facility: Klinikum Bayreuth
city: Berlin
country: Germany
facility: Vivantes Auguste-Viktoria Klinikum
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukölln
city: Berlin
country: Germany
facility: Unfallkrankenhaus Berlin
city: Berlin
country: Germany
facility: Vivantes Humboldt Klinikum GmbH
city: Bielefeld
country: Germany
facility: Evangelisches Krankenhaus Bielefeld gGmbH
city: Bochum
country: Germany
facility: Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH
city: Bochum
country: Germany
facility: St. Josef Hospital Ruhr University Bochum
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Bottrop
country: Germany
facility: Knappschaftskrankenhaus Bottrop GmbH
city: Bremerhaven
country: Germany
facility: Klinikum Bremerhaven-Reinkenheide gGmbH
city: Buchholz
country: Germany
facility: Krankenhaus Buchholz und Winsen gGmbH
city: Castrop-Rauxel
country: Germany
facility: Evangelisches Krankenhaus Castrop-Rauxel
city: Celle
country: Germany
facility: Allgemeines Krankenhaus Celle
city: Coburg
country: Germany
facility: REGIOMED-Kliniken - Klinikum Coburg
city: Damme
country: Germany
facility: Krankenhaus St. Elisabeth gGmbH
city: Dortmund
country: Germany
facility: Klinikum Dortmund gGmbH
city: Dresden
country: Germany
facility: Städtisches Klinikum Dresden-Neustadt
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus Dresden
city: Duisburg
country: Germany
facility: Evangelisches Klinikum Niederrhein gGmbH
city: Emden
country: Germany
facility: Klinikum Emden, Hans-Susemihl Krankenhaus
city: Essen
country: Germany
facility: Alfried Krupp Krankenhaus Rüttenscheid
city: Essen
country: Germany
facility: University Hospital Essen, Department of Neurology
city: Frankfurt am Main
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universität
city: Frankfurt
country: Germany
facility: Klinikum Frankfurt Höchst GmbH
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Fulda
country: Germany
facility: Klinikum Fulda gAG
city: Gelsenkirchen
country: Germany
facility: Evangelische Kliniken Gelsenkirchen gGmbH
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera GmbH
city: Gummersbach
country: Germany
facility: Klinikum Oberberg - Kreiskrankenhaus Gummersbach GmbH
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen, Georg-August-Universität
city: Halle (Saale)
country: Germany
facility: Krankenhaus Martha-Maria Halle-Dölau
city: Halle
country: Germany
facility: UKH Universitätsklinikum Halle (Saale)
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Asklepios Klinik Wandsbek
city: Hamburg
country: Germany
facility: Asklepios Klinik Barmbek
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Hattingen
country: Germany
facility: Evangelisches Krankenhaus Hattingen gGmbH
city: Hausham
country: Germany
facility: Krankenhaus Agatharied GmbH
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Herne
country: Germany
facility: Evangelisches Krankenhaus Herne
city: Hessisch Oldendorf
country: Germany
facility: BDH-Klinik Hessisch-Oldendorf GmbH
city: Ibbenbüren
country: Germany
facility: Klinikum Ibbenbüren GmbH
city: Idar-Oberstein
country: Germany
facility: Klinikum Idar-Oberstein GmbH
city: Karlsbad
country: Germany
facility: SHR Klinikum Karlsbad-Langensteinbach GmbH
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel
city: Krefeld
country: Germany
facility: Alexianer Krefeld GmbH, Krankenhaus Maria-Hilf
city: Köln
country: Germany
facility: Universitätsklinikum Köln
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig AöR
city: Lohr
country: Germany
facility: Klinikum Main-Spessart, Krankenhaus Lohr
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen gGmbH
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck
city: Lübeck
country: Germany
facility: Sana Kliniken Luebeck GmbH
city: Lüneburg
country: Germany
facility: Städtisches Klinikum Lüneburg gGmbH
city: Lünen
country: Germany
facility: St.-Marien-Hospital GmbH
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim
city: Merzig
country: Germany
facility: Klinikum Merzig
city: Minden
country: Germany
facility: Mühlenkreiskliniken AöR, Johannes Wesling Klinikum Minden
city: Moers
country: Germany
facility: St. Josef Krankenhaus GmbH Moers
city: Mönchengladbach
country: Germany
facility: Kliniken Maria Hilf GmbH
city: Münster
country: Germany
facility: UKM Universitätsklinikum Münster
city: Neubrandenburg
country: Germany
facility: Dietrich-Bonhoeffer-Klinikum Neubrandenburg
city: Osnabrück
country: Germany
facility: Klinikum Osnabrück GmbH
city: Recklinghausen
country: Germany
facility: Klinikum Vest GmbH, Behandlungszentrum Knappschaftskrankenhaus Recklinghausen
city: Rendsburg
country: Germany
facility: Imland Klinik Rendsburg
city: Saarbrücken
country: Germany
facility: Klinikum Saarbrücken gGmbH
city: Sande
country: Germany
facility: Nordwest-Krankenhaus Sanderbusch
city: Schwäbisch Hall
country: Germany
facility: Diakonie-Klinikum Schwäbisch Hall gGmbH
city: Seesen
country: Germany
facility: ASKLEPIOS Kliniken Schildautal Seesen
city: Siegen
country: Germany
facility: Kreisklinikum Siegen
city: Sonneberg
country: Germany
facility: Medinos Kliniken Sonneberg
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart - Katharinenhospital
city: Suhl
country: Germany
facility: SRH Zentralklinikum Suhl GmbH
city: Teupitz
country: Germany
facility: Asklepios Fachklinikum Teupitz
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Ulm
country: Germany
facility: RKU - Universitäts- und Rehabilitationskliniken Ulm gGmbH
city: Westerstede
country: Germany
facility: Ammerland Klinik GmbH
city: Wiesbaden
country: Germany
facility: HELIOS Dr. Horst Schmidt Kliniken Wiesbaden
city: Winnenden
country: Germany
facility: Rems-Murr-Klinikum Winnenden
city: Wismar
country: Germany
facility: Sana HANSE-Klinikum Wismar
city: Wolfsburg
country: Germany
facility: Klinikum Wolfsburg
city: Würselen
country: Germany
facility: Rhein-Maas-Klinikum GmbH
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg AöR
Study officials:
affiliation: University Hospital, Essen
name: Hans Diener, Prof. Dr.
role: STUDY_DIRECTOR
References: