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Completed

NCT Number: NCT02507856

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Altenburger Land GmbH, Altenburg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Major bleeding event rate

    Time frame: from study inclusion up to 3 months

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

Secondary outcomes

  1. Complications during hospitalisation

    Time frame: from index event up to 1 week

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

  2. Number of participants with newly occurring or recurrent strokes

    Time frame: from study inclusion up to 3 months

    Stroke (hemorrhagic, ischemic or uncertain classification)

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

    Time frame: from study inclusion up to 3 months

  4. Number of participants with newly occurring or recurrent TIA

    Time frame: from study inclusion up to 3 months

    transient ischemic attack

  5. Number of participants with systemic embolism

    Time frame: from study inclusion up to 3 months

  6. Number of participants with pulmonary embolism

    Time frame: from study inclusion up to 3 months

  7. Number of participants with myocardial infarction

    Time frame: from study inclusion up to 3 months

  8. Life-threatening bleeding events

    Time frame: from study inclusion up to 3 months

  9. Any cause of death

    Time frame: from study inclusion up to 3 months

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

  10. Point in time for withdrawal/change of medication

    Time frame: from study inclusion up to 3 months

  11. Reason for withdrawal/change of medication

    Time frame: from study inclusion up to 3 months

  12. Patient compliance

    Time frame: from study inclusion up to 3 months

  13. Treatment persistence

    Time frame: from study inclusion up to 3 months

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

    Time frame: from study inclusion up to 3 months

  15. Survival one year after study inclusion

    Time frame: up to 1 year from study inclusion

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

Sponsors and collaborators

Lead sponsor

University Hospital, Essen

Other

Registry information

Acronym: PRODAST

Important dates

Study start
2015
Primary completion
2021
Study completion
2022
First posted
Jul 24, 2015
Registry last updated
May 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.