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

University Hospital, Essen10,044 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

10,044

Conditions

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

Eligibility

Medical Language ↔ Plain English

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.

Locations (90)

Klinikum Altenburger Land GmbH

Altenburg, Germany

Kreisklinik Altötting

Altötting, Germany

Schön Klinik Bad Aibling

Bad Aibling, Germany

Hochtaunus-Kliniken gGmbH, Krankenhaus Bad Homburg

Bad Homburg, Germany

Neurologische Klinik Bad Neustadt a. d. Saale

Bad Neustadt an der Saale, Germany

Outcomes

Primary Outcomes

Major bleeding event rate

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

Time frame: from study inclusion up to 3 months

Secondary Outcomes

Complications during hospitalisation

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

Time frame: from index event up to 1 week

Number of participants with newly occurring or recurrent strokes

Stroke (hemorrhagic, ischemic or uncertain classification)

Time frame: from study inclusion up to 3 months

Severity of stroke assessed by modified Rankin Scale (mRS)

Time frame: from study inclusion up to 3 months

Number of participants with newly occurring or recurrent TIA

transient ischemic attack

Time frame: from study inclusion up to 3 months

Number of participants with systemic embolism

Time frame: from study inclusion up to 3 months

Number of participants with pulmonary embolism

Time frame: from study inclusion up to 3 months

Number of participants with myocardial infarction

Time frame: from study inclusion up to 3 months

Life-threatening bleeding events

Time frame: from study inclusion up to 3 months

Any cause of death

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

Time frame: from study inclusion up to 3 months

Point in time for withdrawal/change of medication

Time frame: from study inclusion up to 3 months

Reason for withdrawal/change of medication

Time frame: from study inclusion up to 3 months

Patient compliance

Time frame: from study inclusion up to 3 months

Treatment persistence

Time frame: from study inclusion up to 3 months

(Serious) Adverse Events (AE/SAE)

Time frame: from study inclusion up to 3 months

Survival one year after study inclusion

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

Time frame: up to 1 year from study inclusion