N/A N=1,313

Patient Convenience Study- NIS RELATE

Atrial Fibrillation

Bottom Line

View on ClinicalTrials.gov: NCT02849509 ↗

Enrolled (actual)

1,313

Serious AEs

0.9%

Results posted

Jul 2019

Primary outcome: Primary: Mean Perception of Anticoagulant Treatment Questionnaire, Part 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second Assessment Compared to Baseline Assessment — 71.4; 79.6; 61.0; 63.2 Unit on scale — p=<0.0001

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Pradaxa (dabigatran) (Drug); Vitamin K antagonist (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Dec 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Perception of Anticoagulant Treatment Questionnaire, Part 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second Assessment Compared to Baseline Assessment	71.4; 79.6; 61.0; 63.2	<0.0001 sig
PRIMARY Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Baseline Assessment	71.4; 82.0; 61.0; 64.4	<0.0001 sig
PRIMARY Mean PACT-Q2 Scores, for Patients in Cohort B, at Second Assessment Compared Between Treatment Groups	78.4; 75.1; 61.5; 59.9	0.0423 sig
PRIMARY Mean PACT-Q2 Scores, for Patients in Cohort B, at Last Assessment Compared Between Treatment Groups	80.4; 76.0; 63.9; 60.9	0.0287 sig
PRIMARY Patient Characterization at Baseline - Categorical Parameters	25.1; 33.2; 53.6; 40.6; 43.3; 29.4	—
PRIMARY Patient Characteristics at Baseline - Duration of Previous VKA Treatment for Cohort A	4.28	—
SECONDARY Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score	3.1; 2.6; 2.0	—
SECONDARY Patient Characteristics at Baseline - HAS-BLED Bleeding Risk Score	1.8; 1.3; 1.1	—
SECONDARY Patient Characteristics at Baseline - Creatinine Clearance	68.114; 75.367; 73.017	—
SECONDARY Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment	79.6; 82.0; 63.2; 64.4	0.1234
SECONDARY Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B	3.4; 3.3; 3.4; 3.3; 2.5; 2.6	—

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).

Eligibility Criteria

Inclusion criteria

Cohort A:

A. Written informed consent prior to participation
A. Female and male patients >= 18 years of age with a diagnosis of non-valvular atrial fibrillation.
A. At least 3 months of continuous VKA treatment for stroke prevention prior to baseline assessment.
A. Patients switched to Pradaxa® according Summary of Product Characteristics and physician's discretion.

Cohort B:

B. Written informed consent prior to participation.
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).
B. Stroke prevention treatment initiated with Pradaxa® or VKA according to Summary of Product Characteristics and physician's discretion.

Exclusion criteria

Contraindication to the use of Pradaxa® or VKA as described in the Summary of Product Characteristics (SmPC).
Patients receiving Pradaxa® or VKA for any other condition than stroke prevention in atrial fibrillation.
Current participation in any clinical trial of a drug or device.
Current participation in an European registry on the use of oral anticoagulation in AF.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02849509). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.