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

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ClinicalTrials.gov Identifier: NCT03311139
Recruitment Status : Completed
First Posted : October 17, 2017
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer

Brief 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.

Condition or disease Intervention/treatment
Atrial Fibrillation Drug: Antithrombotic agents

Study Type : Observational
Actual Enrollment : 14226 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Treatment and Outcomes Among Patients With Atrial Fibrillation and Acute Coronary Syndrome in Sweden
Actual Study Start Date : November 16, 2017
Actual Primary Completion Date : March 23, 2018
Actual Study Completion Date : March 23, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Antiplatelets and anticoagulants purchased 4 months before and within 7 days after the index date

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

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




Primary Outcome Measures :
  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)




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Population-based national Swedish dataset covering entire population without selection
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03311139


Locations
Sweden
Many locations
Multiple Locations, Sweden
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03311139     History of Changes
Other Study ID Numbers: 19562
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Atrial Fibrillation
Acute Coronary Syndrome
Anticoagulation

Additional relevant MeSH terms:
Atrial Fibrillation
Acute Coronary Syndrome
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action