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

Recruiting

Phase N/A Results N/A

Trial Description

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

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial 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.

Outcomes

Type Measure Time Frame Safety Issue
Primary Major bleeding event rate from study inclusion up to 3 months Yes
Secondary Complications during hospitalisation from index event up to 1 week Yes
Secondary Number of participants with newly occurring or recurrent strokes from study inclusion up to 3 months Yes
Secondary Severity of stroke assessed by modified Rankin Scale (mRS) from study inclusion up to 3 months Yes
Secondary Number of participants with newly occurring or recurrent TIA from study inclusion up to 3 months Yes
Secondary Number of participants with systemic embolism from study inclusion up to 3 months Yes
Secondary Number of participants with pulmonary embolism from study inclusion up to 3 months Yes
Secondary Number of participants with myocardial infarction from study inclusion up to 3 months Yes
Secondary Life-threatening bleeding events from study inclusion up to 3 months Yes
Secondary Any cause of death from study inclusion up to 3 months Yes
Secondary Point in time for withdrawal/change of medication from study inclusion up to 3 months Yes
Secondary Reason for withdrawal/change of medication from study inclusion up to 3 months Yes
Secondary Patient compliance from study inclusion up to 3 months Yes
Secondary Treatment persistence from study inclusion up to 3 months Yes
Secondary (Serious) Adverse Events (AE/SAE) from study inclusion up to 3 months Yes
Secondary Survival one year after study inclusion up to 1 year from study inclusion Yes

Sponsors