Patient Convenience Study- NIS RELATE

• Status: Completed
• Trial end date: 2017-12-30
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this non-interventional study is to describe patient's perception of anticoagulant treatment when using Pradaxa® to prevent stroke and systemic embolism while suffering from atrial fibrillation (according to its approved indication in the approved dosages of 110 mg or 150 mg twice daily) in comparison to standard care using Vitamin K Antagonist (VKA).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Dabigatran; Vitamin K; Vitamins

Criteria

Inclusion criteria:

Cohort A:

1. A. Written informed consent prior to participation

2. A. Female and male patients >= 18 years of age with a diagnosis of non-valvular atrial fibrillation.

3. A. At least 3 months of continuous VKA treatment for stroke prevention prior to baseline assessment.

4. A. Patients switched to Pradaxa® according Summary of Product Characteristics and physician's discretion.

OR

Cohort B:

1. B. Written informed consent prior to participation.

2. B. Female and male patients >= 18 years of age newly diagnosed with non-valvular atrial fibrillation and no previous treatment for stroke prevention (no use of any oral anticoagulant (OAC) within one year prior to enrolment).

3. B. Stroke prevention treatment initiated with Pradaxa® or VKA according to Summary of Product Characteristics and physician's discretion.

Exclusion criteria:

1. Contraindication to the use of Pradaxa® or VKA as described in the Summary of Product Characteristics (SmPC).

2. Patients receiving Pradaxa® or VKA for any other condition than stroke prevention in atrial fibrillation.

3. Current participation in any clinical trial of a drug or device.

4. Current participation in an European registry on the use of oral anticoagulation in AF.