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

Study Overview
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Brief Summary
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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.

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

Conditions
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Brain Ischemia With Non-valvular Atrial Fibrillation, Transient Ischemic Attack With Non-valvular Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| investigational group<br>early/late dabigatran | |
| control group<br>vitamin k antagonist (vka) | |

What is the study measuring?
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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 |