check_circleStudy Completed

Atrial Fibrillation

Bayer Identifier:

19562

ClinicalTrials.gov Identifier:

NCT03311139

EudraCT Number:

Not Available

EU CT Number:

Not Available
Treatment and outcomes of atrial fibrillation and acute coronary syndrome in Sweden

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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.

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

Trial summary

Enrollment Goal
14226
Trial Dates
November 2017 - March 2018
Phase
N/A
Could I Receive a placebo
No
Products
Unspecified
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locationsMany locations, Sweden

Primary Outcome

  • Composition of treatment regimens
    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).
    date_rangeTime Frame:
    Minimum 3 months and up to 5 years and 1 month
  • Frequency of treatment regimens
    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).
    date_rangeTime Frame:
    Minimum 3 months and up to 5 years and 1 month
  • Prescribed strength of the most common regimens
    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)
    date_rangeTime Frame:
    Minimum 3 months and up to 5 years and 1 month
  • Prescribed treatment duration of the most common regimens
    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)
    date_rangeTime Frame:
    Minimum 3 months and up to 5 years and 1 month
  • Hospitalization or death with a diagnosis of bleeding as safety outcome
    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)
    date_rangeTime Frame:
    Minimum 3 months and up to 5 years and 1 month
  • Hospitalization for recurrent Acute Coronary Syndrom (ACS) as effectiveness outcome
    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)
    date_rangeTime Frame:
    Minimum 3 months and up to 5 years and 1 month
  • Revascularization procedure ( percutaneous stenting procedure or coronary bypass grafting) as effectiveness outcome
    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)
    date_rangeTime Frame:
    Minimum 3 months and up to 5 years and 1 month
  • Ischaemic stroke or systemic embolism as effectiveness outcome
    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)
    date_rangeTime Frame:
    Minimum 3 months and up to 5 years and 1 month
  • Death from any cause as effectiveness outcome
    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)
    date_rangeTime Frame:
    Minimum 3 months and up to 5 years and 1 month

Trial design

Treatment and outcomes among patients with atrial fibrillation and acute coronary syndrome in Sweden
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A