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

NCT ID: NCT03311139

Last Updated: 2019-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14226 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-16

Study Completion Date

2018-03-23

Brief Summary

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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

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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AF and ACS patients: No PCI

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

Antithrombotic agents

Intervention Type DRUG

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)

Antithrombotic agents

Intervention Type DRUG

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)

Antithrombotic agents

Intervention Type DRUG

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

Interventions

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Antithrombotic agents

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Many locations

Multiple Locations, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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19562

Identifier Type: -

Identifier Source: org_study_id

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