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

Completed

• Conditions: Transient Ischemic Attack With Non-valvular Atrial Fibrillation; Brain Ischemia With Non-valvular Atrial Fibrillation

• Registration Number: NCT02507856
• Lead Sponsor: University Hospital, Essen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-16
• Study First Submitted QC: 2015-07-22
• Study First Posted: 2015-07-24
• Primary Completion: 2021-12
• Study Completion: 2022-04
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-09
• Last Update Posted: 2022-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10044

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major bleeding event rate	from study inclusion up to 3 months	Major bleeding event rate within 3 months following the index event (= stroke or TIA)

Secondary Outcome Measures

Name	Time	Method
Complications during hospitalisation	from index event up to 1 week	Complications during hospitalisation before study inclusion (= signature of informed consent)
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
Severity of stroke assessed by modified Rankin Scale (mRS)	from study inclusion up to 3 months
Patient compliance	from study inclusion up to 3 months
Number of participants with newly occurring or recurrent TIA	from study inclusion up to 3 months	transient ischemic attack
Number of participants with newly occurring or recurrent strokes	from study inclusion up to 3 months	Stroke (hemorrhagic, ischemic or uncertain classification)
Survival one year after study inclusion	up to 1 year from study inclusion	any cause of death (non-vascular, vascular or unknown cause)
Number of participants with systemic embolism	from study inclusion up to 3 months
Life-threatening bleeding events	from study inclusion up to 3 months
Any cause of death	from study inclusion up to 3 months	any cause of death (non-vascular, vascular or unknown cause)
Point in time for withdrawal/change of medication	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
Reason for withdrawal/change of medication	from study inclusion up to 3 months

Trial Locations

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

Klinikum Bayreuth; 🇩🇪 Bayreuth, Germany

Vivantes Auguste-Viktoria Klinikum; 🇩🇪 Berlin, Germany

Vivantes Klinikum Neukölln; 🇩🇪 Berlin, Germany

Unfallkrankenhaus Berlin; 🇩🇪 Berlin, Germany

Vivantes Humboldt Klinikum GmbH; 🇩🇪 Berlin, Germany

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