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

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.

Study Overview

• Status: Completed
• Conditions: Brain Ischemia With Non-valvular Atrial Fibrillation; Transient Ischemic Attack With Non-valvular Atrial Fibrillation

• Study Type: Observational
• Enrollment (Actual): 10044

Contacts and Locations

Study Locations

• Germany
  • Altenburg, Germany, 04600
    • Klinikum Altenburger Land GmbH
  • Altötting, Germany, 84503
    • Kreisklinik Altötting
  • Bad Aibling, Germany, 83043
    • Schon Klinik Bad Aibling
  • Bad Homburg, Germany, 61352
    • Hochtaunus-Kliniken gGmbH, Krankenhaus Bad Homburg
  • Bad Neustadt an der Saale, Germany, 97616
    • Neurologische Klinik Bad Neustadt a. d. Saale
  • Bayreuth, Germany, 95445
    • Klinikum Bayreuth
  • Berlin, Germany, 12683
    • Unfallkrankenhaus Berlin
  • Berlin, Germany, 12351
    • Vivantes Klinikum Neukölln
  • Berlin, Germany, 12157
    • Vivantes Auguste-Viktoria Klinikum
  • Berlin, Germany, 13509
    • Vivantes Humboldt Klinikum GmbH
  • Bielefeld, Germany, 33611
    • Evangelisches Krankenhaus Bielefeld gGmbH
  • Bochum, Germany, 44789
    • Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH
  • Bochum, Germany, 44791
    • St. Josef Hospital Ruhr University Bochum
  • Bonn, Germany, 53127
    • Universitätsklinikum Bonn
  • Bottrop, Germany, 46242
    • Knappschaftskrankenhaus Bottrop GmbH
  • Bremerhaven, Germany, 27574
    • Klinikum Bremerhaven-Reinkenheide gGmbH
  • Buchholz, Germany, 21244
    • Krankenhaus Buchholz und Winsen gGmbH
  • Castrop-Rauxel, Germany, 44577
    • Evangelisches Krankenhaus Castrop-Rauxel
  • Celle, Germany, 29223
    • Allgemeines Krankenhaus Celle
  • Coburg, Germany, 96450
    • REGIOMED-Kliniken - Klinikum Coburg
  • Damme, Germany, 49401
    • Krankenhaus St. Elisabeth gGmbH
  • Dortmund, Germany, 44137
    • Klinikum Dortmund gGmbH
  • Dresden, Germany, 01129
    • Städtisches Klinikum Dresden-Neustadt
  • Dresden, Germany, 01304
    • Universitätsklinikum Carl Gustav Carus Dresden
  • Duisburg, Germany, 47169
    • Evangelisches Klinikum Niederrhein gGmbH
  • Emden, Germany, 26721
    • Klinikum Emden, Hans-Susemihl Krankenhaus
  • Essen, Germany, 45131
    • Alfried Krupp Krankenhaus Rüttenscheid
  • Essen, Germany, 45147
    • University Hospital Essen, Department of Neurology
  • Frankfurt, Germany, 65929
    • Klinikum Frankfurt Höchst GmbH
  • Frankfurt am Main, Germany, 60528
    • Klinikum der Johann Wolfgang Goethe-Universität
  • Freiburg, Germany, 79106
    • Universitätsklinikum Freiburg
  • Fulda, Germany, 36043
    • Klinikum Fulda gAG
  • Gelsenkirchen, Germany, 45879
    • Evangelische Kliniken Gelsenkirchen gGmbH
  • Gera, Germany, 07548
    • SRH Wald-Klinikum Gera GmbH
  • Gummersbach, Germany, 51643
    • Klinikum Oberberg - Kreiskrankenhaus Gummersbach GmbH
  • Göttingen, Germany, 37075
    • Universitätsmedizin Göttingen, Georg-August-Universität
  • Halle, Germany, 06120
    • UKH Universitätsklinikum Halle (Saale)
  • Halle (Saale), Germany, 06056
    • Krankenhaus Martha-Maria Halle-Dölau
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg-Eppendorf
  • Hamburg, Germany, 22291
    • Asklepios Klinik Barmbek
  • Hamburg, Germany, 22043
    • Asklepios Klinik Wandsbek
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Hattingen, Germany, 45525
    • Evangelisches Krankenhaus Hattingen gGmbH
  • Hausham, Germany, 83734
    • Krankenhaus Agatharied GmbH
  • Heidelberg, Germany, 69120
    • Universitätsklinikum Heidelberg
  • Herne, Germany, 44623
    • Evangelisches Krankenhaus Herne
  • Hessisch Oldendorf, Germany, 31840
    • BDH-Klinik Hessisch-Oldendorf GmbH
  • Ibbenbüren, Germany, 49477
    • Klinikum Ibbenbüren gmbH
  • Idar-Oberstein, Germany, 55743
    • Klinikum Idar-Oberstein GmbH
  • Karlsbad, Germany, 76307
    • SHR Klinikum Karlsbad-Langensteinbach GmbH
  • Kiel, Germany, 24105
    • Universitätsklinikum Schleswig-Holstein, Campus Kiel
  • Krefeld, Germany, 47805
    • Alexianer Krefeld GmbH, Krankenhaus Maria-Hilf
  • Köln, Germany, 50924
    • Universitätsklinikum Köln
  • Leipzig, Germany, 04103
    • Universitätsklinikum Leipzig AöR
  • Lohr, Germany, 97816
    • Klinikum Main-Spessart, Krankenhaus Lohr
  • Ludwigshafen, Germany, 67063
    • Klinikum der Stadt Ludwigshafen gGmbh
  • Lübeck, Germany, 23538
    • Universitätsklinikum Schleswig-Holstein Campus Lübeck
  • Lübeck, Germany, 23560
    • Sana Kliniken Luebeck GmbH
  • Lüneburg, Germany, 21339
    • Städtisches Klinikum Lüneburg gGmbH
  • Lünen, Germany, 44534
    • St.-Marien-Hospital GmbH
  • Magdeburg, Germany, 39120
    • Universitätsklinikum Magdeburg
  • Mainz, Germany, 55131
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Mannheim, Germany, 68167
    • Universitätsmedizin Mannheim
  • Merzig, Germany, 66663
    • Klinikum Merzig
  • Minden, Germany, 32492
    • Mühlenkreiskliniken AöR, Johannes Wesling Klinikum Minden
  • Moers, Germany, 47441
    • St. Josef Krankenhaus GmbH Moers
  • Mönchengladbach, Germany, 41063
    • Kliniken Maria Hilf GmbH
  • Münster, Germany, 48149
    • UKM Universitätsklinikum Münster
  • Neubrandenburg, Germany, 17036
    • Dietrich-Bonhoeffer-Klinikum Neubrandenburg
  • Osnabrück, Germany, 49076
    • Klinikum Osnabrück GmbH
  • Recklinghausen, Germany, 45657
    • Klinikum Vest GmbH, Behandlungszentrum Knappschaftskrankenhaus Recklinghausen
  • Rendsburg, Germany, 24768
    • Imland Klinik Rendsburg
  • Saarbrücken, Germany, 66119
    • Klinikum Saarbrücken gGmbH
  • Sande, Germany, 26452
    • Nordwest-Krankenhaus Sanderbusch
  • Schwäbisch Hall, Germany, 74523
    • Diakonie-Klinikum Schwäbisch Hall gGmbH
  • Seesen, Germany, 38723
    • ASKLEPIOS Kliniken Schildautal Seesen
  • Siegen, Germany, 57076
    • Kreisklinikum Siegen
  • Sonneberg, Germany, 96515
    • MEDINOS Kliniken Sonneberg
  • Stuttgart, Germany, 70174
    • Klinikum Stuttgart - Katharinenhospital
  • Suhl, Germany, 98527
    • SRH Zentralklinikum Suhl GmbH
  • Teupitz, Germany, 15755
    • ASKLEPIOS Fachklinikum Teupitz
  • Tübingen, Germany, 72076
    • Universitätsklinikum Tübingen
  • Ulm, Germany, 89081
    • RKU - Universitäts- und Rehabilitationskliniken Ulm gGmbH
  • Westerstede, Germany, 26655
    • Ammerland Klinik GmbH
  • Wiesbaden, Germany, 65199
    • Helios Dr. Horst Schmidt Kliniken Wiesbaden
  • Winnenden, Germany, 71364
    • Rems-Murr-Klinikum Winnenden
  • Wismar, Germany, 23966
    • Sana HANSE-Klinikum Wismar
  • Wolfsburg, Germany, 38440
    • Klinikum Wolfsburg
  • Würselen, Germany, 52146
    • Rhein-Maas-Klinikum GmbH
  • Würzburg, Germany, 97080
    • Universitätsklinikum Würzburg AÖR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
investigational group; early/late dabigatran
control group; vitamin k antagonist (vka)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Essen

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: July 16, 2015
• First Submitted That Met QC Criteria: July 22, 2015
• First Posted (Estimate): July 24, 2015

Study Record Updates

• Last Update Posted (Actual): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Stroke; Brain Ischemia; Ischemia; Ischemic Attack, Transient; Atrial Fibrillation
• Other Study ID Numbers: PRODAST