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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT02433366
Date of registration: 25/03/2015
Prospective Registration: No
Primary sponsor: Boehringer Ingelheim
Public title: Evaluation the Effectiveness of the Risk Minimisation Activities in the Treatment of Stroke Prevention in Atrial Fibrillation
Scientific title: Post-authorisation Study to Evaluate the Effectiveness of the Risk Minimisation Activities in the Treatment of SPAF
Date of first enrolment: January 2015
Target sample size: 1213
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02433366
Study type:  Observational
Study design:   
Phase:  N/A
Countries of recruitment
Bulgaria Czech Republic Denmark France Germany Slovakia Spain United Kingdom
Contacts
Name:     Boehringer Ingelheim
Address: 
Telephone:
Email:
Affiliation:  Boehringer Ingelheim
Key inclusion & exclusion criteria

Inclusion criteria:

- Pradaxa® prescribers (cardiologists and primary care physicians)

- Patients with atrial fibrillation treated with Pradaxa®

Exclusion criteria:

As defined in Summary of Product Characteristics for patients treated with Pradaxa®



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Atrial Fibrillation
Intervention(s)
Primary Outcome(s)
Patient's Understanding of the Disease, Bleeding Signs, What to do in Case of Bleeding and How to Deal With Emergency Situations (Measuring Physician Compliance From Patient Perspective) (Questionnaire) [Time Frame: Day 1]
Physician's Knowledge and Recommendations to Their Patients on Appropriate Dosing and Minimizing the Risk of Bleeding When Treated With Pradaxa® (Questionnaire) [Time Frame: Day 1]
Secondary Outcome(s)
Secondary ID(s)
1160.149
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 19/09/2016
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02433366
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