N/A
N=963
This Study Observes the Use of New Oral Anticoagulants (NOACs) in Patients With a Heart Rhythm Disorder in Spain
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT03285373 ↗Enrolled (actual)
963
Serious AEs
1.0%
Results posted
Feb 2020
Primary outcome: Primary: Usage of NOAC Based on Baseline Characteristics: Age at the Time of the First NOAC Initiation — 72.8; 72.5; 72.6; 74.0 Years
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- NOAC (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Usage of NOAC Based on Baseline Characteristics: Age at the Time of the First NOAC Initiation |
72.8; 72.5; 72.6; 74.0; 72.8 | — |
| PRIMARY Usage of NOAC Based on Baseline Characteristics: CHA2DS2-VASc Scores at the Time of the First NOAC Initiation |
3.2; 3.3; 3.3; 3.3; 3.3 | — |
| PRIMARY Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation |
3; 10; 3; 0; 16; 53 | — |
| PRIMARY Usage of NOAC Based on Baseline Characteristics: HAS-BLED Score at the Time of the First NOAC Initiation |
1.8; 1.8; 1.7; 1.8; 1.8 | — |
| PRIMARY Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation |
17; 29; 27; 11; 84; 219 | — |
| SECONDARY Appropriateness of NOACs Prescription |
88; 10; 16; 16; 271; 102 | — |
| SECONDARY Mean Number of Visits to the Physician Per Year |
2.0 | — |
| SECONDARY Duration of First NOAC, All NOAC and Subsequent NOAC Treatment |
9.4; 9.6; 5.1 | — |
| SECONDARY Number of Patients Who Required Discontinuing the NOAC Treatment, to Adjust the NOAC Dose or to Change to a New NOAC |
4; 20; 32; 907 | — |
| SECONDARY Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose |
5; 4; 1; 2; 4; 2 | — |
| SECONDARY Reason for Treatment Changes |
5; 30; 7; 14 | — |
| SECONDARY Number of Patients With Previous Treatment With Vitamin K Antagonists |
146; 125; 100; 53; 424; 168 | — |
| SECONDARY Duration of Previous VKA Treatment |
46.6; 37.0; 54.5; 34.0; 43.8 | — |
| SECONDARY Patient's Knowledge About His Condition |
845; 118; 820; 143; 766; 197 | — |
Summary
The primary objective of the study is to describe the usage of NOACs in patients with NVAF, in the hospital setting, based on the baseline characteristics at the time of first NOAC initiation.
Eligibility Criteria
Inclusion Criteria
- The patient is willing and provides written informed consent to participate in this study
- The patient is at least 18 years of age
- The patient has a diagnosis of non-valvular atrial fibrillation (NVAF)
- The patient is on treatment with NOAC according to its approved local SmPC and has initiated his first NOAC starting from November 2016
Exclusion Criteria
-if the current participating patient participate in any clinical trial of a drug or device will be excluded
Data sourced from ClinicalTrials.gov (NCT03285373). 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.