Atrial Fibrillation
Conditions
Brief summary
The study objective is to confirm appropriate use and safety profile of Prazaxa® Capsules in real-world setting after the availability of idarucizumab
Detailed description
The study is Post-Marketing Surveillance on the Long-Term Use of Prazaxa® Capsules in Japanese patients with nonvalvular atrial fibrillation after the availability of idarucizumab. Even after the availability of idarucizumab in real clinical practice, appropriate use of Prazaxa® Capsules will continue. The patient population who receive Prazaxa® Capsules and the safety profile of Prazaxa® Capsules is not expected to change. This study investigates appropriate use with prospective investigation in the routine medical practice
Interventions
DRUGPrazaxa® Capsules
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) for a treatment duration of 52 weeks.
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female patients with nonvalvular atrial fibrillation who have never received Prazaxa® Capsules / dabigatran etexilate for preventing the occurrence of ischemic stroke and systemic embolism before enrolment in Japan
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Suspected Adverse Drug Reactions (ADRs) | From baseline till the last administration + 6 days. Up to 364 days. | Percentage of patients with suspected adverse drug reactions (ADRs). An adverse drug reaction is defined as a response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility. Percentages were pre-specified to be rounded to two decimal places. |
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
All subjects were screened for eligibility prior to participation in the trial. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated. Out of the 5660 enrolled subjects case report forms (CRF) were collected for 5565 subjects. It was pre-specified to combine the dose groups into one arm as the objective is to confirm appropriate use and safety profile of Prazaxa® in a real-world setting and not to compare between different dose groups.
Participants by arm
| Arm | Count |
|---|---|
| Patients With Nonvalvular Atrial Fibrillation (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) for a treatment duration of 52 weeks. | 5,436 |
| Total | 5,436 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 480 |
| Overall Study | Improvement of nonvalvular atrial fibrillation | 629 |
| Overall Study | Lost to follow-up (changing hospital) | 373 |
| Overall Study | Lost to follow-up (unknown reason) | 146 |
| Overall Study | No actual visit | 120 |
| Overall Study | Other personal reason | 509 |
| Overall Study | Patients received Prazaxa treatment before | 5 |
| Overall Study | Registration rule not followed | 4 |
| Overall Study | To conduct invasive treatment of operation | 53 |
| Overall Study | To take a contraindication/careful administration drug | 8 |
Baseline characteristics
| Characteristic | Patients With Nonvalvular Atrial Fibrillation (NVAF) | — |
|---|---|---|
| Age, Continuous | 69.8 years STANDARD_DEVIATION 11.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 1624 Participants | — |
| Sex: Female, Male Male | 3812 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 51 / 5,436 |
| other Total, other adverse events | 0 / 5,436 |
| serious Total, serious adverse events | 416 / 5,436 |
Outcome results
Primary
Percentage of Patients With Suspected Adverse Drug Reactions (ADRs)
Percentage of patients with suspected adverse drug reactions (ADRs). An adverse drug reaction is defined as a response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility. Percentages were pre-specified to be rounded to two decimal places.
Time frame: From baseline till the last administration + 6 days. Up to 364 days.
Population: Safety Set 1: This patient set included all patients who were documented to take at least one dose of Prazasa® except patients who experienced with Prazaxa® treatment for the prevention of ischemic stroke and Systemic Embolism, who did not followed registration rules, who registered outside the site contract period and/or who made no visit after the entry.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Nonvalvular Atrial Fibrillation (NVAF) | Percentage of Patients With Suspected Adverse Drug Reactions (ADRs) | 10.69 Percentage of participants |