Atrial Fibrillation
Conditions
Brief summary
To investigate the safety and efficacy of long-term use of Prazaxa® Capsules in patients with nonvalvular atrial fibrillation for preventing the occurrence of ischemic stroke or systemic embolism (SEE).
Interventions
DRUGPrazaxa
Dabigatran etexilate
Sponsors
Boehringer Ingelheim
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
\- Patients with nonvalvular atrial fibrillation who have never received Prazaxa Capsules for preventing the occurrence of ischemic stroke and systemic embolism will be included.
Exclusion criteria
\- None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency (Percentage) of Participants With Adverse Drug Reactions | Up to 104 weeks from first administration of study drug | Percentage of participants with adverse drug reactions (ADRs) is presented. An ADR is defined as an adverse event (AE) for which either the investigator or the sponsor (or both) assess the causal relationship to Prazaxa® Capsules either as Related, Probably related, or Cannot be denied. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidences of Stroke and Systemic Embolism (SEE) | Up to 104 weeks from first administration of study drug | Incidence rate of Stroke and SEE (number of patients per 100 patient year) with 95% confidence interval (CI) is reported. Stroke and SEE were recorded as adverse events (AEs) of special interest. Exact Poisson confidence intervals are presented for incidence rate. |
Countries
Japan
Participant flow
Recruitment details
Post-Marketing Surveillance on the Long-Term Use of Prazaxa® Capsules in patients with nonvalvular atrial fibrillation
Pre-assignment details
6772 subjects were enrolled. Among them, Electronic Case Report Form (eCRF) was not collected for 144 subjects and 185 subjects were excluded because of them not following registration rule, no actual visit or previous treatment experience with Prazaxa, leaving 6443 subjects eligible for study who were enrolled and included in the final study.
Participants by arm
| Arm | Count |
|---|---|
| Patients With NVAF Patients with nonvalvular atrial fibrillation (NVAF) taking daily oral dose of Prazaxa® Capsules (Dabigatran etexilate). Dosage of Dabigatran etexilate approved in Japan: 300 milligram (mg) daily (150 mg \[as 2 capsules of 75 mg\] twice a day (b.i.d)) or 220 mg (110 mg \[as 1 capsule of 110 mg\] b.i.d) | 6,443 |
| Total | 6,443 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1,016 |
| Overall Study | Improvement of NVAF | 210 |
| Overall Study | Lost to follow-up (changing hospital) | 545 |
| Overall Study | Lost to follow-up (unknown reason) | 287 |
| Overall Study | Other than specified above | 657 |
| Overall Study | To conduct invasive treatment | 59 |
| Overall Study | To take a contraindication | 20 |
Baseline characteristics
| Characteristic | Patients With NVAF |
|---|---|
| Age, Continuous | 70.9 Years STANDARD_DEVIATION 9.9 |
| Sex: Female, Male Female | 2133 Participants |
| Sex: Female, Male Male | 4310 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 408 / 6,443 |
| serious Total, serious adverse events | 618 / 6,443 |
Outcome results
Primary
Frequency (Percentage) of Participants With Adverse Drug Reactions
Percentage of participants with adverse drug reactions (ADRs) is presented. An ADR is defined as an adverse event (AE) for which either the investigator or the sponsor (or both) assess the causal relationship to Prazaxa® Capsules either as Related, Probably related, or Cannot be denied.
Time frame: Up to 104 weeks from first administration of study drug
Population: Safety set: This patient set includes all patients who received treatment of Prazaxa® Capsules except those who were found not following registration rule, no actual visit, previous treatment experience with Prazaxa.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With NVAF | Frequency (Percentage) of Participants With Adverse Drug Reactions | 28.2 Percentage of participants |
Secondary
Incidences of Stroke and Systemic Embolism (SEE)
Incidence rate of Stroke and SEE (number of patients per 100 patient year) with 95% confidence interval (CI) is reported. Stroke and SEE were recorded as adverse events (AEs) of special interest. Exact Poisson confidence intervals are presented for incidence rate.
Time frame: Up to 104 weeks from first administration of study drug
Population: Effectiveness set: This analysis set included all patients who received treatment of Prazaxa® Capsules except those who were found not following registration rule, no actual visit, previous treatment experience with Prazaxa, contraindication and / or who did not suffer from NVAF.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With NVAF | Incidences of Stroke and Systemic Embolism (SEE) | 1.27 Number of patients per 100 patient year |