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Brain Ischemia With Non-valvular Atrial FibrillationPRODASTNCT02507856

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

An observational study of Brain Ischemia With Non-valvular Atrial Fibrillation and Transient Ischemic Attack With Non-valvular Atrial Fibrillation, run by University Hospital, Essen at 90 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
10,044 participants
Where
90 sitesGermany
Study dates
Jul 2015to Apr 2022
How long will I take part?
3 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

90 sites in 1 country.

90 sites in 1 country

Germany90 sites

  • Klinikum Altenburger Land GmbH

    Altenburg, 04600

  • Kreisklinik Altötting

    Altötting, 84503

  • Schön Klinik Bad Aibling

    Bad Aibling, 83043

  • Hochtaunus-Kliniken gGmbH, Krankenhaus Bad Homburg

    Bad Homburg, 61352

  • Neurologische Klinik Bad Neustadt a. d. Saale

    Bad Neustadt an der Saale, 97616

  • Klinikum Bayreuth

    Bayreuth, 95445

  • Vivantes Auguste-Viktoria Klinikum

    Berlin, 12157

  • Vivantes Klinikum Neukölln

    Berlin, 12351

  • Unfallkrankenhaus Berlin

    Berlin, 12683

  • Vivantes Humboldt Klinikum GmbH

    Berlin, 13509

  • Evangelisches Krankenhaus Bielefeld gGmbH

    Bielefeld, 33611

  • Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH

    Bochum, 44789

  • St. Josef Hospital Ruhr University Bochum

    Bochum, 44791

  • Universitätsklinikum Bonn

    Bonn, 53127

  • Knappschaftskrankenhaus Bottrop GmbH

    Bottrop, 46242

  • Klinikum Bremerhaven-Reinkenheide gGmbH

    Bremerhaven, 27574

  • Krankenhaus Buchholz und Winsen gGmbH

    Buchholz, 21244

  • Evangelisches Krankenhaus Castrop-Rauxel

    Castrop-Rauxel, 44577

  • Allgemeines Krankenhaus Celle

    Celle, 29223

  • REGIOMED-Kliniken - Klinikum Coburg

    Coburg, 96450

  • Universitätsklinikum Köln

    Cologne, 50924

  • Krankenhaus St. Elisabeth gGmbH

    Damme, 49401

  • Klinikum Dortmund gGmbH

    Dortmund, 44137

  • Städtisches Klinikum Dresden-Neustadt

    Dresden, 01129

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 01304

  • Evangelisches Klinikum Niederrhein gGmbH

    Duisburg, 47169

  • Klinikum Emden, Hans-Susemihl Krankenhaus

    Emden, 26721

  • Alfried Krupp Krankenhaus Rüttenscheid

    Essen, 45131

  • University Hospital Essen, Department of Neurology

    Essen, 45147

  • Klinikum Frankfurt Höchst GmbH

    Frankfurt, 65929

  • Klinikum der Johann Wolfgang Goethe-Universität

    Frankfurt am Main, 60528

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Klinikum Fulda gAG

    Fulda, 36043

  • Evangelische Kliniken Gelsenkirchen gGmbH

    Gelsenkirchen, 45879

  • SRH Wald-Klinikum Gera GmbH

    Gera, 07548

  • Universitätsmedizin Göttingen, Georg-August-Universität

    Göttingen, 37075

  • Klinikum Oberberg - Kreiskrankenhaus Gummersbach GmbH

    Gummersbach, 51643

  • Krankenhaus Martha-Maria Halle-Dölau

    Halle, 06056

  • UKH Universitätsklinikum Halle (Saale)

    Halle, 06120

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Asklepios Klinik Wandsbek

    Hamburg, 22043

  • Asklepios Klinik Barmbek

    Hamburg, 22291

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Evangelisches Krankenhaus Hattingen gGmbH

    Hattingen, 45525

  • Krankenhaus Agatharied GmbH

    Hausham, 83734

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Evangelisches Krankenhaus Herne

    Herne, 44623

  • BDH-Klinik Hessisch-Oldendorf GmbH

    Hessisch Oldendorf, 31840

  • Klinikum Ibbenbüren GmbH

    Ibbenbueren, 49477

  • Klinikum Idar-Oberstein GmbH

    Idar-Oberstein, 55743

  • SHR Klinikum Karlsbad-Langensteinbach GmbH

    Karlsbad, 76307

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105

  • Alexianer Krefeld GmbH, Krankenhaus Maria-Hilf

    Krefeld, 47805

  • Universitätsklinikum Leipzig AöR

    Leipzig, 04103

  • Klinikum Main-Spessart, Krankenhaus Lohr

    Lohr, 97816

  • Universitätsklinikum Schleswig-Holstein Campus Lübeck

    Lübeck, 23538

  • Sana Kliniken Luebeck GmbH

    Lübeck, 23560

  • Klinikum der Stadt Ludwigshafen gGmbH

    Ludwigshafen, 67063

  • Städtisches Klinikum Lüneburg gGmbH

    Lüneburg, 21339

  • St.-Marien-Hospital GmbH

    Lünen, 44534

  • Universitätsklinikum Magdeburg

    Magdeburg, 39120

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131

  • Universitätsmedizin Mannheim

    Mannheim, 68167

  • Klinikum Merzig

    Merzig, 66663

  • Mühlenkreiskliniken AöR, Johannes Wesling Klinikum Minden

    Minden, 32492

  • St. Josef Krankenhaus GmbH Moers

    Moers, 47441

  • Kliniken Maria Hilf GmbH

    Mönchengladbach, 41063

  • UKM Universitätsklinikum Münster

    Münster, 48149

  • Dietrich-Bonhoeffer-Klinikum Neubrandenburg

    Neubrandenburg, 17036

  • Klinikum Osnabrück GmbH

    Osnabrück, 49076

  • Klinikum Vest GmbH, Behandlungszentrum Knappschaftskrankenhaus Recklinghausen

    Recklinghausen, 45657

  • Imland Klinik Rendsburg

    Rendsburg, 24768

  • Klinikum Saarbrücken gGmbH

    Saarbrücken, 66119

  • Nordwest-Krankenhaus Sanderbusch

    Sande, 26452

  • Diakonie-Klinikum Schwäbisch Hall gGmbH

    Schwäbisch Hall, 74523

  • ASKLEPIOS Kliniken Schildautal Seesen

    Seesen, 38723

  • Kreisklinikum Siegen

    Siegen, 57076

  • Medinos Kliniken Sonneberg

    Sonneberg, 96515

  • Klinikum Stuttgart - Katharinenhospital

    Stuttgart, 70174

  • SRH Zentralklinikum Suhl GmbH

    Suhl, 98527

  • Asklepios Fachklinikum Teupitz

    Teupitz, 15755

  • Universitätsklinikum Tübingen

    Tübingen, 72076

  • RKU - Universitäts- und Rehabilitationskliniken Ulm gGmbH

    Ulm, 89081

  • Ammerland Klinik GmbH

    Westerstede, 26655

  • HELIOS Dr. Horst Schmidt Kliniken Wiesbaden

    Wiesbaden, 65199

  • Rems-Murr-Klinikum Winnenden

    Winnenden, 71364

  • Sana HANSE-Klinikum Wismar

    Wismar, 23966

  • Klinikum Wolfsburg

    Wolfsburg, 38440

  • Rhein-Maas-Klinikum GmbH

    Würselen, 52146

  • Universitätsklinikum Würzburg AöR

    Würzburg, 97080

Other trials in Germany

About this study

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.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02507856
Study groupRoleWhat they receive
investigational groupearly/late dabigatran
control groupvitamin k antagonist (vka)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major bleeding event rate

    Major bleeding event rate within 3 months following the index event (= stroke or TIA)

    Measured: from study inclusion up to 3 months

Secondary outcomes (15)

  1. Complications during hospitalisation

    Complications during hospitalisation before study inclusion (= signature of informed consent)

    Measured: from index event up to 1 week

  2. Number of participants with newly occurring or recurrent strokes

    Stroke (hemorrhagic, ischemic or uncertain classification)

    Measured: from study inclusion up to 3 months

  3. Severity of stroke assessed by modified Rankin Scale (mRS)

    Measured: from study inclusion up to 3 months

  4. Number of participants with newly occurring or recurrent TIA

    transient ischemic attack

    Measured: from study inclusion up to 3 months

  5. Number of participants with systemic embolism

    Measured: from study inclusion up to 3 months

  6. Number of participants with pulmonary embolism

    Measured: from study inclusion up to 3 months

  7. Number of participants with myocardial infarction

    Measured: from study inclusion up to 3 months

  8. Life-threatening bleeding events

    Measured: from study inclusion up to 3 months

  9. Any cause of death

    any cause of death (non-vascular, vascular or unknown cause)

    Measured: from study inclusion up to 3 months

  10. Point in time for withdrawal/change of medication

    Measured: from study inclusion up to 3 months

  11. Reason for withdrawal/change of medication

    Measured: from study inclusion up to 3 months

  12. Patient compliance

    Measured: from study inclusion up to 3 months

  13. Treatment persistence

    Measured: from study inclusion up to 3 months

  14. (Serious) Adverse Events (AE/SAE)

    Measured: from study inclusion up to 3 months

  15. Survival one year after study inclusion

    any cause of death (non-vascular, vascular or unknown cause)

    Measured: up to 1 year from study inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionDec 2021
  4. Study completionApr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10,044 participants (actual)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02507856
Sponsor's protocol ID
PRODAST
Acronym
PRODAST
Status last verified
May 2022
First submitted
16 Jul 2015
Last updated
10 May 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 39895532

Questions about this trial

What is this clinical trial studying?

An observational study of Brain Ischemia With Non-valvular Atrial Fibrillation and Transient Ischemic Attack With Non-valvular Atrial Fibrillation, run by University Hospital, Essen at 90 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major bleeding event rate (time frame: from study inclusion up to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02507856, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.

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