Patient Convenience Study- NIS RELATE

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02849509
• Date of registration: 04/05/2016
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim
• Public title: Patient Convenience Study- NIS RELATE
• Scientific title: Non-interventional Study Describing Patients' Perception on Anticoagulant Treatment and Treatment Convenience When Treated With Pradaxa or Vitamin K Antagonist for Stroke Prophylaxis in Atrial Fibrillation.
• Date of first enrolment: June 20, 2016
• Target sample size: 1313
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02849509
• Study type: Observational

Countries of recruitment

Indonesia, Korea, Republic of, Malaysia, Singapore, Thailand, Turkey, Vietnam

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Atrial Fibrillation

Intervention(s)

Drug: Pradaxa (dabigatran)

Drug: Vitamin K antagonist

Primary Outcome(s)

Mean PACT-Q2 Scores, for Patients in Cohort B, at Last Assessment Compared Between Treatment Groups [Time Frame: Last assessment - Visit 3 (125-365 days after initiation on Pradaxa or VKA)]

Mean PACT-Q2 Scores, for Patients in Cohort B, at Second Assessment Compared Between Treatment Groups [Time Frame: Second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA)]

Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Baseline Assessment [Time Frame: Visit 1 (Baseline) and last assessment Visit 3 (125-365 days after initiation on Pradaxa or VKA)]

Mean Perception of Anticoagulant Treatment Questionnaire, Part 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second Assessment Compared to Baseline Assessment [Time Frame: Visit 1 (Baseline) and second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA)]

Patient Characteristics at Baseline - Duration of Previous VKA Treatment for Cohort A [Time Frame: Baseline (Visit1)]

Patient Characterization at Baseline - Categorical Parameters [Time Frame: Baseline (Visit1)]

Secondary Outcome(s)

Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B [Time Frame: Baseline (Visit1)]

Patient Characteristics at Baseline - Creatinine Clearance [Time Frame: Baseline (Visit1)]

Patient Characteristics at Baseline - HAS-BLED Bleeding Risk Score [Time Frame: Baseline (Visit1)]

Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment [Time Frame: Second assessment - Visit 2 (7-124 days after initiation on Pradaxa or VKA) and last assessment - Visit 3 (125-365 days after initiation on Pradaxa or VKA)]

Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score [Time Frame: Baseline (Visit1)]

Secondary ID(s)

1160.261

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 08/07/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02849509