Prospective Record Of the use of Dabigatran in patients with Acute Stroke or TIA (PRODAST)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/26744
• EU PAS number:
  EUPAS8525
• Study ID:
  26744
• Official title and acronym:
  Prospective Record Of the use of Dabigatran in patients with Acute Stroke or TIA (PRODAST)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  The multi-center, prospective PRODAST study is investigating patients with TIA or ischemic stroke and non-valvular AF 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, the study will use data from the first as well as from the second prescribed medication. To explore a long-term effect of anticoagulation, survival up to one year will be assessed.
• Study status:
  Finalised

Research institutions and networks

Institutions

Multiple centres: 100 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 22/12/2014

Study start date

Actual: 02/07/2015

Data analysis start date

Planned: 27/04/2022

Actual: 27/04/2022

Date of final study report

Actual: 15/03/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim Pharma GmbH

Study protocol

Initial protocol

PRODAST_Beobachtungsplan_V3 8_20150609_Unterschr_geschwärzt

Updated protocol

PRODAST_Beobachtungsplan_V5.0_20180924_geschwärzt

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

ClinicalTrials.gov Identifier: NCT02507856 https://clinicaltrials.gov/ct2/show/NCT02507856?titles=prodast&rank=1