ClinicalTrials.gg
CompletedNCT03311139Updated Jan 14, 2019

Treatment and Outcomes of Atrial Fibrillation and Acute Coronary Syndrome in Sweden

An observational study in Atrial Fibrillation, sponsored by Bayer. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-14.

Sponsored by Bayer · Observational

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
14,226
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 64 studies in Atrial Fibrillation by Bayer — 1 open to participants now, 1 under way, none of them phase 3. Atrial Fibrillation · Bayer.

Enrollment
20th of 51
14,226 · median 3,055
Started
2017
with 5 others
Observational
51 of 64
none open now
Registered
44th of 64
by date

Among the 64 studies in Atrial Fibrillation by Bayer, this one is the 20th largest by enrollment of the 51 observational ones that give a count, is one of 6 that started in 2017, is one of 51 observational ones, and was the 44th registered.

Atrial Fibrillation

4,009 studies on the registry are indexed under Atrial Fibrillation; 960 are open to participants now.

Browse Atrial Fibrillation studies →

Open to participants now

1 of the 64 studies in Atrial Fibrillation by Bayer is open now, in 8 countries. Recruiting first, the newest first:

By country, each count listing its studies:

Who these studies take

Of the 611 Atrial Fibrillation studies recruiting now, 407 (67%) set no upper age limit and 43 (7%) stop at 75 or younger; 21 take children under 18; 43 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

Many people who suffer from irregular heartbeats (atrial fibrillation) which might cause stroke, need to take blood thinners to prevent it. However, people with atrial fibrillation are also at increased risk of acute myocardial infarction or unstable angina pectoris (another heart condition marked by a chest pain, comprising so-called acute coronary syndrome for which another type of treatment that prevents blood from clotting (antiplatelet treatment) is indicated. In particularly if such patients undergo percutaneous coronary intervention, a procedure aimed to open up diseased blood vessels and hence to treat acute coronary syndrome, this treatment is needed. If a patients takes several anti-clotting blood drugs, the risk of bleeding is high. The number of possible drug combinations and treatment durations is large. This study will help us to understand which anti-clotting drug combinations are prescribed in real life among patients with atrial fibrillation and acute coronary syndrome, how effective and safe they are for patients. The study will look into the data that are already available in several very large Swedish databases which contain information needed for the research.

03

Conditions studied

  • Atrial Fibrillation

Keywords

  • Atrial Fibrillation
  • Acute Coronary Syndrome
  • Anticoagulation
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Population-based national Swedish dataset covering entire population without selection

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of ACS defined by a hospital discharge (ICD-10 code of I21 for myocardial infarction or I20.0 for unstable angina pectoris (with or without sub-codes) during the study period and a diagnosis of AF (ICD-10 code I48 with or without sub-codes) in the Patient Register before or on the same day as the patient was discharged for ACS.

Exclusion criteria

Exclusion Criteria:

  • No exclusions will be made as the registries capture the entire life-time of entire population of Sweden.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
14,226 participants (actual)
Patient registry
No

Groups and cohorts

  • AF and ACS patients: No PCI

    Patients with Atrial Fibrillation and Acute Coronary Syndrom who did not undergo a Percutaneous Coronary Intervention

    Drug: Antithrombotic agents

  • AF and ACS patients: PCI without stent

    Patients with Atrial Fibrillation and Acute Coronary Syndrom who underwent PCI without stent implantation (NOMESCO code FNG00-96 except FNG05)

    Drug: Antithrombotic agents

  • AF and ACS patients: PCI with stent

    Patients with Atrial Fibrillation and Acute Coronary Syndrom who underwent PCI with stent implantation (NOMESCO code FNG05)

    Drug: Antithrombotic agents

Interventions

  • Antiplatelets and anticoagulants purchased 4 months before and within 7 days after the index date

06

What researchers measure

Primary outcomes

  1. Composition of treatment regimens

    combinations of a vitamin K antagonist, antiplatelet therapy, a P2Y12 inhibitor without or with rivaroxaban in patients: who did not undergo Percutaneous Coronary Intervention (PCI), who underwent PCI without stent implantation (NOMESCO code FNG00-96 except FNG05), who underwent PCI with stent implantation (NOMESCO code FNG05).

    Time frame: Minimum 3 months and up to 5 years and 1 month

  2. Frequency of treatment regimens

    frequency of identified drug combinations of a vitamin K antagonist, antiplatelet therapy, a P2Y12 inhibitor without or with rivaroxaban in patients: who did not undergo Percutaneous Coronary Intervention (PCI), who underwent PCI without stent implantation (NOMESCO code FNG00-96 except FNG05), who underwent PCI with stent implantation (NOMESCO code FNG05).

    Time frame: Minimum 3 months and up to 5 years and 1 month

  3. Prescribed strength of the most common regimens

    prescribed strength of identified drug combinations of a vitamin K antagonist, antiplatelet therapy, a P2Y12 inhibitor without or with rivaroxaban in patients: who did not undergo Percutaneous Coronary Intervention (PCI), who underwent PCI without stent implantation (NOMESCO code FNG00-96 except FNG05), who underwent PCI with stent implantation (NOMESCO code FNG05)

    Time frame: Minimum 3 months and up to 5 years and 1 month

  4. Prescribed treatment duration of the most common regimens

    prescribed duration of identified drug combinations of a vitamin K antagonist, antiplatelet therapy, a P2Y12 inhibitor without or with rivaroxaban in patients: who did not undergo Percutaneous Coronary Intervention (PCI), who underwent PCI without stent implantation (NOMESCO code FNG00-96 except FNG05), who underwent PCI with stent implantation (NOMESCO code FNG05)

    Time frame: Minimum 3 months and up to 5 years and 1 month

  5. Hospitalization or death with a diagnosis of bleeding as safety outcome

    Total observation time is from 1st December 2011 and will include patients up to 31st December 2016. The analysis will be done in patients: who did not undergo Percutaneous Coronary Intervention (PCI), who underwent PCI without stent implantation (NOMESCO code FNG00-96 except FNG05), who underwent PCI with stent implantation (NOMESCO code FNG05)

    Time frame: Minimum 3 months and up to 5 years and 1 month

  6. Hospitalization for recurrent Acute Coronary Syndrom (ACS) as effectiveness outcome

    Total observation time is from 1st December 2011 and will include patients up to 31st December 2016. The analysis will be done in patients: who did not undergo Percutaneous Coronary Intervention (PCI), who underwent PCI without stent implantation (NOMESCO code FNG00-96 except FNG05), who underwent PCI with stent implantation (NOMESCO code FNG05)

    Time frame: Minimum 3 months and up to 5 years and 1 month

  7. Revascularization procedure ( percutaneous stenting procedure or coronary bypass grafting) as effectiveness outcome

    Total observation time is from 1st December 2011 and will include patients up to 31st December 2016. The analysis will be done in patients: who did not undergo Percutaneous Coronary Intervention (PCI), who underwent PCI without stent implantation (NOMESCO code FNG00-96 except FNG05), who underwent PCI with stent implantation (NOMESCO code FNG05)

    Time frame: Minimum 3 months and up to 5 years and 1 month

  8. Ischaemic stroke or systemic embolism as effectiveness outcome

    Total observation time is from 1st December 2011 and will include patients up to 31st December 2016. The analysis will be done in patients: who did not undergo Percutaneous Coronary Intervention (PCI), who underwent PCI without stent implantation (NOMESCO code FNG00-96 except FNG05), who underwent PCI with stent implantation (NOMESCO code FNG05)

    Time frame: Minimum 3 months and up to 5 years and 1 month

  9. Death from any cause as effectiveness outcome

    Total observation time is from 1st December 2011 and will include patients up to 31st December 2016. The analysis will be done in patients: who did not undergo Percutaneous Coronary Intervention (PCI), who underwent PCI without stent implantation (NOMESCO code FNG00-96 except FNG05), who underwent PCI with stent implantation (NOMESCO code FNG05)

    Time frame: Minimum 3 months and up to 5 years and 1 month

07

Study locations

1 site
  • Many locations
    Multiple Locations, Sweden
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2017 to primary completion in Mar 2018, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 28, 2017
First posted
Oct 17, 2017
StartActual
Nov 16, 2017
Primary completionActual
Mar 23, 2018
CompletionActual
Mar 23, 2018
Last update
Jan 14, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03311139
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Oct 17, 2017
Start date
Nov 16, 2017
Primary completion
Mar 23, 2018
Completion
Mar 23, 2018
Last update
Jan 14, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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