Japanese Pradaxa PMS, Long Term

An observational study of Atrial Fibrillation, run by Boehringer Ingelheim at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The study objective is to confirm appropriate use and safety profile of Prazaxa® Capsules in real-world setting after the availability of idarucizumab Read more about this study

Who is it for?: Ages 15 years and older
Conditions the study is for: Atrial Fibrillation
What is being tested?: Prazaxa® Capsules
Type of treatment: Pill or oral medicine
How many people: 5,660 participants
Where: 1 siteJapan
Study dates: 5 Jul 2017to 12 Jan 2021
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: An observational study, no specific treatment is mandated or withheld from the patients. The choice of maintenance treatment for nonvalvular atrial fibrillation must be according to regular medical practice and at discretion of physician (i.e., no randomised assignment of patient to treatment [Prazaxa® Capsules or other treatment] is performed).

Who may be able to join

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

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

Japan1 site

Nippon Boehringer Ingelheim Co., Ltd
Tokyo

Other trials in Japan

About this study

Official title: Post-Marketing Surveillance on the Use of Prazaxa® Capsules in Japanese Patients With Nonvalvular Atrial Fibrillation After the Availability of Idarucizumab

The study objective is to confirm appropriate use and safety profile of Prazaxa® Capsules in real-world setting after the availability of idarucizumab

Read the 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

Conditions: Atrial Fibrillation
Being tested: Prazaxa® Capsules
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prazaxa® CapsulesDrug
Also called 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.

Study groups in NCT03175198
Study group	Role	What they receive
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. Receives: Drug: Prazaxa® Capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: From baseline till the last administration + 6 days. Up to 364 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jul 201712 Jan 2021

First posted5 Jun 2017
Study start5 Jul 2017
Primary completion21 Dec 2020
Study completion12 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 5,660 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03175198
Sponsor's protocol ID: 1160-0284
Status last verified: Feb 2022
First submitted: 1 Jun 2017
Last updated: 6 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-Marketing Surveillance on the Use of Prazaxa® Capsules in Japanese Patients With Nonvalvular Atrial Fibrillation After the Availability of Idarucizumab
ClinicalTrials.gov ID: NCT03175198
Acronym / sponsor ID: 1160-0284
Conditions: Atrial Fibrillation
Study type: Observational
Recruitment status: Completed
Enrolment: 5,660 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 5 Jul 2017 (actual)
Primary completion: 21 Dec 2020 (actual)
Study completion: 12 Jan 2021 (actual)
First posted: 5 Jun 2017 (actual)
Results: Posted 6 Apr 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients with nonvalvular atrial fibrillation (NVAF)	–	Drug: Prazaxa® CapsulesPatients 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.

Who may qualify

Ages: 15 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: An observational study, no specific treatment is mandated or withheld from the patients. The choice of maintenance treatment for nonvalvular atrial fibrillation must be according to regular medical practice and at discretion of physician (i.e., no randomised assignment of patient to treatment [Prazaxa® Capsules or other treatment] is performed).

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Prazaxa® CapsulesAlso: Dabigatran etexilateDosage 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.	Drug	Patients with nonvalvular atrial fibrillation (NVAF)

Primary outcome

Percentage of Patients With Suspected Adverse Drug Reactions (ADRs)
Time frame: 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.

Results and safety

Results posted to the registry on 6 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients With Nonvalvular Atrial Fibrillation (NVAF)	5,565	3,238

Primary outcome: Percentage of Patients With Suspected Adverse Drug Reactions (ADRs)

Time frame: From baseline till the last administration + 6 days. Up to 364 days.. Number. Unit: Percentage of participants

Measure	Patients With Nonvalvular Atrial Fibrillation (NVAF) n = 5436
Value	10.69

Population analysed: 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.

Adverse events

Time frame: From baseline till the last administration + 6 days. Up to 364 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients With Nonvalvular Atrial Fibrillation (NVAF)	416 of 5,436 (7.7%)	0 of 5,436 (0%)	51 of 5,436

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Atrial Fibrillation

Active, not recruiting
ARIADNE Clinical Trial
Persistent Atrial Fibrillation
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Not yet recruitingPhase 4
A Comparison of Beta-blockers and Calcium Channel Blockers in Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruiting
CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rie Ikeda, 81364172200 study chair

zzCDMJP_PV_PMS@boehringer-ingelheim.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by Boehringer Ingelheim at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients With Suspected Adverse Drug Reactions (ADRs) (time frame: From baseline till the last administration + 6 days. Up to 364 days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03175198.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.