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

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ClinicalTrials.gov Identifier: NCT02507856
Recruitment Status : Recruiting
First Posted : July 24, 2015
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Hans Diener, 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.

Condition or disease
Brain Ischemia With Non-valvular Atrial Fibrillation Transient Ischemic Attack With Non-valvular Atrial Fibrillation

Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Prospective Record Of the Use of Dabigatran in Patients With Acute Stroke or TIA
Study Start Date : July 2015
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : March 2022


Group/Cohort
investigational group
early/late dabigatran
control group
vitamin k antagonist (vka)



Primary Outcome Measures :
  1. Major bleeding event rate [ Time Frame: from study inclusion up to 3 months ]
    Major bleeding event rate within 3 months following the index event (= stroke or TIA)


Secondary Outcome Measures :
  1. Complications during hospitalisation [ Time Frame: from index event up to 1 week ]
    Complications during hospitalisation before study inclusion (= signature of informed consent)

  2. Number of participants with newly occurring or recurrent strokes [ Time Frame: from study inclusion up to 3 months ]
    Stroke (hemorrhagic, ischemic or uncertain classification)

  3. Severity of stroke assessed by modified Rankin Scale (mRS) [ Time Frame: from study inclusion up to 3 months ]
  4. Number of participants with newly occurring or recurrent TIA [ Time Frame: from study inclusion up to 3 months ]
    transient ischemic attack

  5. Number of participants with systemic embolism [ Time Frame: from study inclusion up to 3 months ]
  6. Number of participants with pulmonary embolism [ Time Frame: from study inclusion up to 3 months ]
  7. Number of participants with myocardial infarction [ Time Frame: from study inclusion up to 3 months ]
  8. Life-threatening bleeding events [ Time Frame: from study inclusion up to 3 months ]
  9. Any cause of death [ Time Frame: from study inclusion up to 3 months ]
    any cause of death (non-vascular, vascular or unknown cause)

  10. Point in time for withdrawal/change of medication [ Time Frame: from study inclusion up to 3 months ]
  11. Reason for withdrawal/change of medication [ Time Frame: from study inclusion up to 3 months ]
  12. Patient compliance [ Time Frame: from study inclusion up to 3 months ]
  13. Treatment persistence [ Time Frame: from study inclusion up to 3 months ]
  14. (Serious) Adverse Events (AE/SAE) [ Time Frame: from study inclusion up to 3 months ]
  15. Survival one year after study inclusion [ Time Frame: up to 1 year from study inclusion ]
    any cause of death (non-vascular, vascular or unknown cause)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study 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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02507856


Contacts
Contact: Hans Diener, Prof. Dr. +49 201/ 723 ext -2460 hans.diener@uk-essen.de
Contact: Christian Weimar, Prof. Dr. +49 201/ 723 ext -6503 christian.weimar@uk-essen.de

  Show 90 Study Locations
Sponsors and Collaborators
University Hospital, Essen
Investigators
Study Director: Hans Diener, Prof. Dr. University Hospital, Essen
Principal Investigator: Christian Weimar, Prof. Dr. University Hospital, Essen
  Study Documents (Full-Text)

Documents provided by Prof. Dr. Hans Diener, University Hospital, Essen:
Study Protocol  [PDF] September 24, 2018


Responsible Party: Prof. Dr. Hans Diener, Prof. Dr. med., University Hospital, Essen
ClinicalTrials.gov Identifier: NCT02507856     History of Changes
Other Study ID Numbers: PRODAST
First Posted: July 24, 2015    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
Ischemic Attack, Transient
Atrial Fibrillation
Ischemia
Stroke
Brain Ischemia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Dabigatran
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants