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

NCT02507856 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10044

Last updated 2022-05-10

No results posted yet for this study

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

Sponsors & Collaborators

  • University Hospital, Essen

    lead OTHER

Principal Investigators

  • Hans Diener, Prof. Dr. · University Hospital, Essen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2021-12-31
Completion
2022-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02507856 on ClinicalTrials.gov