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

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Antithrombotic agents

• Registration Number: NCT03311139
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-09-28
• Study First Submitted QC: 2017-10-10
• Study First Posted: 2017-10-17
• Study Start: 2017-11-16
• Primary Completion: 2018-03-23
• Study Completion: 2018-03-23
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-10
• Last Update Posted: 2019-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14226

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AF and ACS patients: No PCI	Antithrombotic agents	Patients with Atrial Fibrillation and Acute Coronary Syndrom who did not undergo a Percutaneous Coronary Intervention
AF and ACS patients: PCI without stent	Antithrombotic agents	Patients with Atrial Fibrillation and Acute Coronary Syndrom who underwent PCI without stent implantation (NOMESCO code FNG00-96 except FNG05)
AF and ACS patients: PCI with stent	Antithrombotic agents	Patients with Atrial Fibrillation and Acute Coronary Syndrom who underwent PCI with stent implantation (NOMESCO code FNG05)

Primary Outcome Measures

Name	Time	Method
Prescribed strength of the most common regimens	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)
Revascularization procedure ( percutaneous stenting procedure or coronary bypass grafting) as effectiveness outcome	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)
Composition of treatment regimens	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).
Frequency of treatment regimens	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).
Prescribed treatment duration of the most common regimens	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)
Hospitalization or death with a diagnosis of bleeding as safety outcome	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)
Hospitalization for recurrent Acute Coronary Syndrom (ACS) as effectiveness outcome	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)
Ischaemic stroke or systemic embolism as effectiveness outcome	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)
Death from any cause as effectiveness outcome	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)

Trial Locations

Locations (1)

Many locations; 🇸🇪 Multiple Locations, Sweden