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NCT Number: NCT03311139

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

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.

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Key information

Conditions

Atrial Fibrillation Acute Coronary Syndrome Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many locations

Multiple Locations, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Antithrombotic agents

Drug

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

Primary outcomes

  1. Composition of treatment regimens

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

    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).

  2. Frequency of treatment regimens

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

    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).

  3. Prescribed strength of the most common regimens

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

    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)

  4. Prescribed treatment duration of the most common regimens

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

    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)

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

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

    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)

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

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

    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)

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

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

    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)

  8. Ischaemic stroke or systemic embolism as effectiveness outcome

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

    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)

  9. Death from any cause as effectiveness outcome

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

    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)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study title

Treatment and Outcomes Among Patients With Atrial Fibrillation and Acute Coronary Syndrome in Sweden

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 17, 2017
Registry last updated
Jan 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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