Clinical trial NCT03311139: Treatment and Outcomes of Atrial Fibrillation and Acute Coronary Syndrome in Sweden
Official title: Treatment and Outcomes Among Patients With Atrial Fibrillation and Acute Coronary Syndrome in Sweden
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Acute Coronary Syndrome
Anticoagulation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2017-10-17
Enrollment: 14226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population-based national Swedish dataset covering entire population without selection

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.


Eligibility 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.

Primary outcomes:
measure: Composition of treatment regimens
timeFrame: Minimum 3 months and up to 5 years and 1 month
measure: Frequency of treatment regimens
timeFrame: Minimum 3 months and up to 5 years and 1 month
measure: Prescribed strength of the most common regimens
timeFrame: Minimum 3 months and up to 5 years and 1 month
measure: Prescribed treatment duration of the most common regimens
timeFrame: Minimum 3 months and up to 5 years and 1 month
measure: Hospitalization or death with a diagnosis of bleeding as safety outcome
timeFrame: Minimum 3 months and up to 5 years and 1 month
measure: Hospitalization for recurrent Acute Coronary Syndrom (ACS) as effectiveness outcome
timeFrame: Minimum 3 months and up to 5 years and 1 month
measure: Revascularization procedure ( percutaneous stenting procedure or coronary bypass grafting) as effectiveness outcome
timeFrame: Minimum 3 months and up to 5 years and 1 month
measure: Ischaemic stroke or systemic embolism as effectiveness outcome
timeFrame: Minimum 3 months and up to 5 years and 1 month
measure: Death from any cause as effectiveness outcome
timeFrame: Minimum 3 months and up to 5 years and 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Multiple Locations
country: Sweden
facility: Many locations
Study officials:
References: